Macular Degeneration: Sharma S

Sharma S. · No affiliation provided · Can J Ophthalmol. · Pubmed #15947796 links to  free full text

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Mandell MA, Sharma S. · University of Toronto, Ontario. · Can Fam Physician. · Pubmed #16805079 links to  free full text

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Brown MM, Brown GC, Sharma S, Stein JD, Roth Z, Campanella J, Beauchamp GR. · Center for Value-Based Medicine, Flourtown 19031, USA. · Curr Opin Ophthalmol. · Pubmed #16794438 No free full text.

Abstract: PURPOSE OF REVIEW: The quality-of-life loss and the financial consequences associated with age-related macular degeneration are assessed. RECENT FINDINGS: The quality-of-life loss associated with macular degeneration is markedly underestimated by the general public, nonophthalmic physicians, and ophthalmologists who treat patients with this condition. Mild age-related macular degeneration causes a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate age-related macular degeneration causes a 40% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or renal dialysis. Very severe age-related macular degeneration causes a large 63% decrease in the average patient's quality of life, similar to that encountered with end-stage prostatic cancer or a catastrophic stroke that leaves a person bedridden, incontinent and requiring constant nursing care. The return on investment is high for both treatment with current age-related macular degeneration therapies and the research costs invested in the development of age-related macular degeneration treatment modalities. SUMMARY: Age-related macular degeneration is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.

Hollands H, Sharma S. · Cost-effective Ocular Health Policy Unit, Queens University, Kingston, Ontario, Canada. · Curr Opin Ophthalmol. · Pubmed #16794433 No free full text.

Abstract: PURPOSE OF REVIEW: The purpose of this review is to summarize the recent and noteworthy utility studies and cost-utility analyses in the area of retina/vitreous during the period January 2004 to January 2006. RECENT FINDINGS: This review considers the cost-effectiveness of treatments for wet age-related macular degeneration, dry age-related macular degeneration, telemedicine in diabetic retinopathy, and utilities and patients with age-related macular degeneration and diabetic retinopathy. SUMMARY: Utilities are being used increasingly to measure health-related quality of life. Cost-utility analyses are becoming more readily available for comparing the incremental cost-effectiveness of different ophthalmic interventions.

Sharma S, Oliver-Fernandez A, Liu W, Buchholz P, Walt J. · Department of Ophthalmology, Queen's University, Kingston, Ontario, Canada. · Curr Opin Ophthalmol. · Pubmed #15870571 No free full text.

Abstract: PURPOSE OF REVIEW: To review recent evidence evaluating the effect of diabetic retinopathy and diabetic macular edema on health-related quality of life. RECENT FINDINGS: A search of PubMed was conducted according to a strategy that combined the text words 'diabetic retinopathy' and 'quality of life' (n = 91; November 11, 2004) and 'diabetic macular edema' and 'quality of life' (n = 6; November 22, 2004). The Methods sections of all abstracts were reviewed for valid generic or disease-specific instruments used to evaluate health-related quality of life. In addition, abstracts were reviewed to ensure that the study sample was made up predominantly of diabetic individuals. Recent data suggest that persons with diabetic retinopathy are willing to trade off significant time to eliminate their ocular condition (mean time tradeoff score = 0.77-0.8) and that laser photocoagulation can improve health-related quality of life (significant improvement noted in 8 of 11 domains in the National Eye Institute Visual Function Questionnaire). In addition, recent research has noted that health-related quality of life can become affected in persons with diabetic retinopathy prior to visual loss, primarily because of anxiety about the future and emotional reaction to diagnosis and treatment. SUMMARY: From a search of the literature, several recent articles could be identified that demonstrated both a qualitative and a quantitative reduction in health-related quality of life in persons with diabetic retinopathy. With many novel treatments being explored for the management of diabetic retinopathy and diabetic macular edema, measuring health-related quality of life will likely play an important role both in the decision to offer treatment and in monitoring relevant health gains that may be derived from intervention.

Sharma S, Oliver-Fernandez A. · Cost Effective Ocular Health Policy Unit, Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Brock II-224B, 116 Brock Street, Kingston, Ontario, Canada K7L 5G2. · Curr Opin Ophthalmol. · Pubmed #15118510 No free full text.

Abstract: PURPOSE OF REVIEW: To review how to critically appraise a research article pertaining to changes in health-related quality of life (HRQoL) related to interventions for age-related macular degeneration (AMD). RECENT FINDINGS: We searched PubMed using a strategy that combined the text-words, "macular degeneration" and "quality of life" (n = 73; January 17, 2004), while limiting the search to "clinical trials" (n = 6; of which 3 were published within the past year). A randomized clinical trial evaluating the efficacy of self-management as an intervention for AMD has been selected to introduce the reader to the concept of how to critically review a research paper pertaining to HRQoL in AMD. Other pertinent articles used in this review include recent results published from the Age-Related Eye Disease Study and the Submacular Surgery Trial. SUMMARY: The NEI-VFQ is a reliable, valid, and responsive tool when applied to patients with AMD. Self-management of patients with AMD has been demonstrated to improve their HRQoL by way of an internally valid randomized clinical trial. In this issue of Current Opinion in Ophthalmology, we confront the issue of how to assess the validity and importance of a research paper pertaining to the issue of quality of life. To introduce this topic, we will present a real world clinical example to better understand how quality of life may aid in medical decision making.

Brown MM, Brown GC, Sharma S. · Center for Value-Based Medicine, 1107 Bethlehem Pike, Flourtown, PA 19031, USA. · Curr Opin Ophthalmol. · Pubmed #15118501 No free full text.

Abstract: PURPOSE OF REVIEW: The purpose of the review is to examine the role of value-based medicine and its impact, or potential impact, on vitreoretinal interventions. RECENT FINDINGS: Value-based medicine integrates evidence-based data from clinical trials with the patient-perceived improvement in quality of life conferred by an intervention. Cost-utility analysis, the healthcare economic instrument used to create a value-based medicine database, is being increasingly used to study the cost-effectiveness of vitreoretinal interventions. SUMMARY: Vitreoretinal interventions are generally cost-effective because of the great value they impart to patients. Laser surgical procedures, such as for diabetic retinopathy, threshold retinopathy of prematurity, and exudative macular degeneration appear to be especially cost-effective as a group.

Busbee BG, Brown MM, Brown GC, Sharma S. · Center for Value-Based Medicine, and Department of Ophthalmology, Tufts New England Medical Center, USA. · Retina. · Pubmed #12824826 No free full text.

Abstract: PURPOSE: The purpose of this study was to perform a reference case (average case), cost-utility analysis of laser photocoagulation for extrafoveal choroidal neovascularization associated with age-related macular degeneration using a model incorporating patient preferences. METHODS: Visual acuity data for patients treated and observed over a 5-year period were obtained from previously reported studies by the Macular Photocoagulation Study Group. The results from this prospective, randomized trial were incorporated in a cost-utility model using time-trade-off utility analysis and decision analysis with Markov modeling according to the recommendations of the Panel on Cost-Effectiveness in Health and Medicine. Expenditures and health care benefits were each discounted at a 3% yearly rate. RESULTS: Laser photocoagulation therapy for extrafoveal choroidal neovascularization in age-related macular degeneration, compared with observation, resulted in a mean gain of 0.0740 quality-adjusted life-year per patient treated. The mean cost of treatment for the average patient totaled 1,715 US dollars. The cost divided by the health care benefit resulted in 23,176 year 2001 US dollars per quality-adjusted life-year gained for this procedure for a reference case. Sensitivity analyses, varying the cost, utility values, and discount parameters, resulted in dollars per quality-adjusted life-year gained ranging from 16,117 to 49,766 US dollars. CONCLUSION: Laser photocoagulation for extrafoveal choroidal neovascularization associated with age-related macular degeneration appears to be cost-effective when compared with interventions across multiple medical specialties.

Sharma S. · Cost-Effective Ocular Health Policy Unit, Hotel Dieu Hospital, 224B-166 Brock St., Kingston ON K7L 5G2. · Can J Ophthalmol. · Pubmed #11227391 No free full text.

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Brown MM, Brown GC, Sharma S, Garrett S. · Cataract and Primary Eye Care Service, Wills Eye Hospital, Philadelphia, Pennsylvania, USA. · Curr Opin Ophthalmol. · Pubmed #10537783 No free full text.

Abstract: Evidence-based medicine provides the highest quality of information for medical practitioners. At the top of the pyramid of evidence-based medicine are the prospective, randomized clinical trials and meta-analysis. Evidence-based medicine can be incorporated with quality-of-life parameters; the latter can be quantified using utility theory. With utility theory, utility values range from 0.0 (death state) to 1.0 (perfect health state). The higher the utility value, the better a person's quality of life. Interventional treatment can change the utility level experienced by a patient. A change in utility value induced by an interventional treatment can be amalgamated with the duration of the treatment effect to provide the number of quality-adjusted life-years (QALYs) gained by a specific treatment (QALYs = [gain in utility value] x [duration of treatment effect]). Thus, this formula takes into account both the improvement in quality of life and the improvement in length of life gained by a treatment. The number of QALYs gained by a treatment can then be incorporated with medical costs (discounted for the time value of money) to arrive at a final common denominator of $/QALY (cost per QALY). The parameter $/QALY can be used to compare the cost-effectiveness of interventional treatments across diverse specialties in medicine. In essence, this methodology allows a measure of the cost-effectiveness of a treatment that incorporates the highest quality of scientific information, clinical efficacy, patient quality-of-life preferences, and realistic costs.

Sayanagi K, Sharma S, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. · Br J Ophthalmol. · Pubmed #19208677 No free full text.

Abstract: AIMS: To evaluate the photoreceptor layer status after antivascular endothelial growth factor (VEGF) therapy in choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) using spectral-domain optical coherence tomography (SD-OCT). DESIGN: Prospective, consecutive case series. METHODS: Twenty-three eyes of 22 patients with CNV secondary to AMD with foveal thickness less than 250 microm after treatment with anti-VEGF therapy and no obvious leakage on time domain OCT, and eight healthy subjects as controls, were imaged with at least one of four different SD-OCT devices. The inner and outer segment (IS/OS) photoreceptor layers were graded, and correlated with various characteristics including visual acuity. RESULTS: The IS/OS layer was detected in eight eyes (35%) of patients with AMD and all eyes (100%) of the healthy control subjects (p = 0.002). Eyes in patients with AMD with preserved IS/OS had a significantly better BCVA and mean change in BCVA, and were more likely not to have had previous laser treatment compared with eyes with absent IS/OS. CONCLUSIONS: SD-OCT is a useful tool to visualise IS/OS status. IS/OS is often absent in patients who have received treatment with anti-VEGF therapy for CNV due to AMD. The IS/OS status after anti-VEFG therapy correlates with BCVA and mean change in vision.

Nagpal M, Nagpal K, Sharma S, Puri J, Nagpal PN. · Retina Foundation, Ahmedabad, Gujarat, India. · Indian J Ophthalmol. · Pubmed #14601850 links to  free full text

Abstract: AIM: To evaluate the efficacy of transpupillary thermotherapy (TTT) for treatment of subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD), and to define accurate power settings for this procedure in Indian eyes. METHODS: A prospective, nonrandomised study of 160 eyes of 144 patients with subfoveal CNV. The laser settings included 2 mm spot and 300 mw power or 3 mm spot and 400-600 mw power. Two separate 3 mm spots were used in larger lesions. The treatment was given for 60 seconds at each point. RESULTS: Ninety-nine eyes had classic membranes and 61 eyes had occult membranes. Following treatment, 79 of 99 (79.8%) classic and 52 of 61 (85%) occult membranes regressed. Visual improvement (> or = 2 lines) was seen in 29 (29.3%) eyes and 12 (19.6%) eyes; visual stabilisation (1 line) in 39 (39.4%) eyes, and 35 (57.4%) eyes; and reduction of vision (< or = 2 lines) in 31 (31.3%) eyes and 14 (22.9%) eyes with classic and occult membranes respectively. Mean follow-up was 12 months. One patient suffered inadvertant foveal burn. CONCLUSION: TTT is effective in the management of subfoveal membranes in Indian eyes. They respond to lower energy levels compared to the Caucasian eyes.

Taban M, Sharma S, Williams DR, Waheed N, Kaiser PK. · Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave., Cleveland, OH 44195, USA. · Ophthalmology. · Pubmed #19410954 No free full text.

Abstract: PURPOSE: To compare automated retinal thickness values generated by the fast macular thickness maps (FMTM) and customized 6-radial line scans (RLS) versus manual retinal measurements on Stratus optical coherence tomography (OCT) (Carl Zeiss Meditec, Dublin, CA). DESIGN: Prospective, observational case series. PARTICIPANTS: Patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD), diabetic macular edema (DME), or branch/central retinal vein occlusion (RVO). METHODS: Patients were prospectively imaged using the FMTM and customized RLS patterns on Stratus OCT at the same sitting. Each scan was evaluated for errors in retinal segmentation (i.e., correct retinal boundaries [CRB]). Automated values were recorded while central retinal thickness measurements were determined manually for both patterns. The presence or absence of epiretinal phenomenon, cystoid spaces, pigment epithelial detachment, and subretinal fluid was also noted. MAIN OUTCOME MEASURES: Errors in retinal segmentation at and outside the fovea (i.e., CRB) and percentage of automated values within a clinically acceptable margin (+/-25 mum) of the manual central retinal thickness. RESULTS: A total of 147 eyes of 147 patients (95 eyes with exudative AMD, 41 eyes with DME, and 11 eyes with macular edema caused by RVO) were included. For wet AMD, the total number of CRB at the fovea and outside the fovea was 363 (63.7%) and 360 (63.2%), respectively, in FMTM and 428 (75.1%) and 426 (74.7%), respectively, in RLS (P<0.0001 for both). For DME and RVO, the total number of CRB at the fovea and outside the fovea was 274 (87.8%) and 256 (82.1%), respectively, in FMTM and 287 (92.0%) and 270 (86.5%), respectively, in RLS (P = 0.11, P = 0.15, respectively). Some 40% and 56% of automated foveal center point thicknesses on FMTM and RLS, respectively, were within +/-25 mum of the manual central retinal thickness for AMD (P = 0.042), versus 94% and 81% for DME and RVO, respectively (P = 0.07). CONCLUSIONS: For exudative AMD, the RLS protocol provides fewer segmentation errors than the FMTM protocol, and its automated retinal thickness values (e.g., foveal center point, central subfield) correlate better with manual retinal thickness measurement than FMTM. In DME and RVO, however, both protocols provide similar and low segmentation errors, and their automated results are close to manual measurements. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Sayanagi K, Sharma S, Yamamoto T, Kaiser PK. · Cole Eye Institute, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. · Ophthalmology. · Pubmed #19232732 No free full text.

Abstract: PURPOSE: To compare the ability to delineate and detect patterns of choroidal neovascularization (CNV) activity in patients with exudative age-related macular degeneration (AMD) after ranibizumab treatment between time-domain optical coherence tomography (TD-OCT) and 4 different spectral-domain optical coherence tomography (SD-OCT) devices. DESIGN: Prospective, consecutive case series. PARTICIPANTS: Sixty-one eyes of 58 patients with exudative AMD after ranibizumab treatment were included in this study. METHODS: All patients were imaged with TD-OCT and at least 1 of 4 different SD-OCT devices at the same visit after ranibizumab treatment. The OCT images were analyzed in a masked fashion by 2 independent graders (KS, TY) to delineate and detect the presence of CNV activity defined as the presence of subretinal fluid, intraretinal cysts, intraretinal fluid, sub-retinal pigment epithelium (sub-RPE) fluid, or a combination thereof. The automated evaluation of retinal thickness also was analyzed between devices. MAIN OUTCOME MEASURES: Evidence of CNV activity on linear B-scans and 3-dimensional so-called cube scans on SD-OCT and linear B-scan on TD-OCT. RESULTS: In linear B-scan mode, all 4 SD-OCT devices were superior in their ability to delineate sub-RPE fluid compared with TD-OCT (P<0.05). Three of 4 SD-OCT devices were superior in delineating intraretinal fluid, and 2 of 4 SD-OCT devices were superior in delineating subretinal fluid and intraretinal cysts (P<0.05). In the 3-dimensional so-called cube mode, all 4 SD-OCT devices were superior in detecting subretinal fluid and 2 of 4 SD-OCT devices were superior in detecting sub-RPE and intraretinal fluid (P<0.05). There were significant correlations in center point thickness between all SD-OCT devices and TD-OCT (P<0.01), and 3 of 4 and 1 of 3 SD-OCT devices showed significant differences from TD-OCT in center point thickness (P<0.01) and center subfield thickness (P<0.001), respectively. CONCLUSIONS: SD-OCT is superior to TD-OCT in evaluating for CNV activity in patients with wet AMD after ranibizumab injection. Retinal thickness measurements between SD-OCT and TD-OCT also were significantly different. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Karanjia R, Eng KT, Gale J, Sharma S, ten Hove MW. · Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, 166 Brock Street, Kingston, ON, Canada, K7L 5G2; · Br J Ophthalmol. · Pubmed #18617547 No free full text.

Abstract: OBJECTIVE: To examine the sensitivity of the multifocal electroretinogram (mf-ERG) at measuring changes in retinal electrical activity in response to Avastin (bevacizumab) treatment for age-related macular degeneration (ARMD). METHODS: Nine subjects with exudative ARMD, not previously treated with bevacizumab in the investigated eye, underwent pretreatment testing with mf-ERG and intravenous fluorescein angiography (IVFA). A second mf-ERG test was conducted post-treatment. The P1 response amplitudes were examined for the hexagons corresponding to areas of pathology on the IVFA. Intertest variability was accounted for by examining areas without pathology. Aggregate responses were also generated for central and lesion-associated responses. RESULTS: Changes in P1 response amplitude correlated with changes in visual acuity (R(2)>0.96). An improvement in Snellen visual acuity correlated with a significant improvement in P1 response amplitude from lesion associated recordings (p<0.03). Changes in P1 response amplitudes were not observed when aggregate responses were generated. CONCLUSION: This study represents a novel method for assessing an improvement of mf-ERG responses. This is the first study to demonstrate a statistically significant change in retinal electrical activity postbevacizumab in patients with ARMD. This study demonstrates a method for utilising mf-ERG to assess changes in retinal electrical activity and to assess the effectiveness of treatments such as bevacizumab.

Brown GC, Brown MM, Brown HC, Kindermann S, Sharma S. · Center for Value-Based Medicine, Flourtown, Pennsylvania, USA. · Trans Am Ophthalmol Soc. · Pubmed #18427606 links to  free full text

Abstract: PURPOSE: To evaluate the comparability of articles in the peer-reviewed literature assessing the (1) patient value and (2) cost-utility (cost-effectiveness) associated with interventions for neovascular age-related macular degeneration (ARMD). METHODS: A search was performed in the National Library of Medicine database of 16 million peer-reviewed articles using the key words cost-utility, cost-effectiveness, value, verteporfin, pegaptanib, laser photocoagulation, ranibizumab, and therapy. All articles that used an outcome of quality-adjusted life-years (QALYs) were studied in regard to (1) percent improvement in quality of life, (2) utility methodology, (3) utility respondents, (4) types of costs included (eg, direct healthcare, direct nonhealthcare, indirect), (5) cost bases (eg, Medicare, National Health Service in the United Kingdom), and (6) study cost perspective (eg, government, societal, third-party insurer). To qualify as a value-based medicine analysis, the patient value had to be measured using the outcome of the QALYs conferred by respective interventions. As with value-based medicine analyses, patient-based time tradeoff utility analysis had to be utilized, patient utility respondents were necessary, and direct medical costs were used. RESULTS: Among 21 cost-utility analyses performed on interventions for neovascular macular degeneration, 15 (71%) met value-based medicine criteria. The 6 others (29%) were not comparable owing to (1) varying utility methodology, (2) varying utility respondents, (3) differing costs utilized, (4) differing cost bases, and (5) varying study perspectives. Among value-based medicine studies, laser photocoagulation confers a 4.4% value gain (improvement in quality of life) for the treatment of classic subfoveal choroidal neovascularization. Intravitreal pegaptanib confers a 5.9% value gain (improvement in quality of life) for classic, minimally classic, and occult subfoveal choroidal neovascularization, and photodynamic therapy with verteporfin confers a 7.8% to 10.7% value gain for the treatment of classic subfoveal choroidal neovascularization. Intravitreal ranibizumab therapy confers greater than a 15% value gain for the treatment of subfoveal occult and minimally classic subfoveal choroidal neovascularization. CONCLUSIONS: The majority of cost-utility studies performed on interventions for neovascular macular degeneration are value-based medicine studies and thus are comparable. Value-based analyses of neovascular ARMD monotherapies demonstrate the power of value-based medicine to improve quality of care and concurrently maximize the efficacy of healthcare resource use in public policy. The comparability of value-based medicine cost-utility analyses has important implications for overall practice standards and public policy. The adoption of value-based medicine standards can greatly facilitate the goal of higher-quality care and maximize the best use of healthcare funds.

Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. · Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Kingston, Ontario, Canada. · J Cataract Refract Surg. · Pubmed #18165083 No free full text.

Abstract: PURPOSE: To evaluate the efficacy of prophylactic administration of the topical nonsteroidal antiinflammatory drug (NSAID) ketorolac tromethamine 0.5% on acute (within 4 weeks of surgery) cystoid macular edema (CME) and total macular volume (TMV) in patients having phacoemulsification cataract surgery. SETTING: Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Kingston, Ontario, Canada. METHODS: This open-label nonmasked randomized (random number assignment) study comprised 106 eyes of 98 patients. Exclusion criteria included hypersensitivity to the NSAID drug class, aspirin/NSAID-induced asthma, and pregnancy in the third trimester. Ketorolac tromethamine 0.5% was administered starting 2 days before surgery and for 29 days after surgery for a total of 31 days. The outcome measure was macular swelling, which was quantified by the optical coherence tomography. RESULTS: At 1 month, there was a statistically significant difference in TMV between the control group (0.4420 mm3) and the ketorolac group (0.2392 mm3), with the ketorolac group having 45.8% less macular swelling (P = .009). Multiple linear regression with backward selection indicated a 44.3% (P = .013) and 46.1% (P = .030) reduction in macular swelling in the ketorolac group at 1 week and 1 month, respectively. CONCLUSION: Used prophylactically after cataract surgery, ketorolac 0.5% was efficacious in decreasing postoperative macular edema.

Hollands H, Wong J, Bruen R, Campbell RJ, Sharma S, Gale J. · Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Kingston, ON K7L 5S9. · Can J Ophthalmol. · Pubmed #18026202 links to  free full text

Abstract: BACKGROUND: This study examines the changes in short-term intraocular pressure (IOP) in patients receiving intravitreally administered bevacizumab. A prospective series of consecutive patients undergoing injection of intravitreal bevacizumab was investigated. METHODS: All patients received bevacizumab (0.05 cc) injected intravitreally in a standard fashion. IOP was measured at baseline, 2, 5, and 30 minutes after injection by 1 of 2 observers using Goldman applanation tonometry. An intraobserver study was done to assess agreement in IOP measurements. RESULTS: We accrued 104 patients with a mean age of 76 years: 58% were female, and 42% were male. Most patients (85%) were being treated for neovascular age-related macular degeneration. The mean IOP values at baseline, 2, 5, and 30 minutes after injection were 14.0 (95% confidence interval [CI] 13.4-14.7) mm Hg, 36.1 (95% CI 33.5-38.6) mm Hg, 25.7 (95% CI 23.8-27.5) mm Hg, and 15.5 (95% CI 12.4-16.51) mm Hg, respectively. Three patients (2.9%) had an IOP of 25 mm Hg or higher at 30 minutes. IOP normalized within 2 hours without medical therapy in 2 of these patients, and 1 patient required a 1-week course of glaucoma medication. Regression analysis showed a trend towards phakic patients having higher IOP at 30 minutes (odds ratio = 3.2; p = 0.089). INTERPRETATION: Intravitreal injection of bevacizumab is safe with respect to short-term IOP changes, as almost all patients' IOP returned to a safe range (<25 mm Hg) within 30 minutes. Elevated IOP at 30 minutes after injection does occur, rarely, thus clinicians should consider checking IOP after injection as a precaution. Transient extreme IOP elevations occur in a significant percentage of patients, but the consequences of these events are unknown.

Brown GC, Brown MM, Brown HC, Kindermann S, Sharma S. · Center for Value-Based Medicine, Flourtown, Pennsylvania 19031, USA. · Ophthalmology. · Pubmed #17320964 No free full text.

Abstract: OBJECTIVE: To perform a value-based medicine analysis of clinical trials that evaluate the interventions of laser photocoagulation, intravitreal pegaptanib therapy, and photodynamic therapy (PDT) with verteporfin for the treatment of classic subfoveal choroidal neovascularization. DESIGN: Reference case cost-utility analysis using value-based medicine principles, which use patient-based utility values and standardized, input variable criteria. PARTICIPANTS: Data from participants in the Macular Photocoagulation Study, Pegaptanib for Neovascular Age-Related Macular Degeneration Study, and the Treatment of Age-Related Macular Degeneration with Photodynamic Therapy Study. METHODS: Visual data were converted to a value-based format using time tradeoff utility analysis values from patients with macular degeneration. Costs were obtained from 2005 Medicare data. Outcomes (quality-adjusted life-years [QALYs]) and costs were discounted at a 3% annual rate. MAIN OUTCOME MEASURES: Interventional QALYs gained, percent improvement in quality of life, and dollars spent per QALY gained. RESULTS: Laser photocoagulation confers a 4.4% (P = 0.03 versus pegaptanib therapy) improvement in quality of life for the reference case, whereas pegaptanib therapy confers a 5.9% improvement and PDT confers an 8.1% (P = 0.0002 versus pegaptanib therapy) improvement. The cost-utility associated with laser photocoagulation is $8179, that for pegaptanib therapy is $66978, and that for PDT is $31544. All sensitivity analyses remain within the conventional standards of cost-effectiveness. CONCLUSIONS: Photodynamic therapy confers greater patient value than intravitreal pegaptanib therapy and laser photocoagulation for the treatment of classic subfoveal choroidal neovascularization. Despite the fact that laser photocoagulation is the most cost-effective intervention, both PDT and pegaptanib therapy deliver greater value, and thus are both preferred over laser photocoagulation. Using an economic measure, photodynamic therapy is the preferred treatment among these 3 interventions.

Schmier JK, Halpern MT, Covert D, Delgado J, Sharma S. · Exponent Inc, Alexandria, VA, USA. · Retina. · Pubmed #17151494 No free full text.

Abstract: BACKGROUND: To assess the patient-reported use of caregiving among individuals with age-related macular degeneration (AMD) and evaluate the impact of visual impairment level on this use. METHODS: A survey including the AMD Health and Impact Questionnaire and the Daily Living Tasks Dependent on Vision Questionnaire (DLTV) was mailed to members of the Macular Degeneration Partnership. The study was approved by an institutional review board, and respondents provided consent before participating. Responses were analyzed by estimated visual acuity determined by scores from the DLTV. Deidentified data were analyzed using SAS Version 8.2 (SAS Institute, Cary, NC). RESULTS: Of 803 respondents, 56% were male, and the mean age was 73 years. Use of paid and unpaid help significantly increased as visual acuity decreased. Using a national average for caregiver time, annual costs for caregiving ranged from 225 to 47,086 US dollar depending on visual acuity. CONCLUSION: There are substantial differences in caregiver support with increased AMD severity. Delaying progression of AMD could result in considerable cost savings.

Schmier JK, Halpern MT, Covert DW, Delgado J, Sharma S. · Exponent Inc., Alexandria, Virginia 22314, USA. · Disabil Rehabil. · Pubmed #17083181 No free full text.

Abstract: PURPOSE: To assess the patient-reported use of services, supplements, and devices among individuals with age-related macular degeneration (AMD) and evaluate the impact of visual impairment level on this use. METHOD: Data for this study were collected using two instruments, the AMD Health and Impact Questionnaire and the Daily Living Tasks Dependent on Vision questionnaire (DLTV). Both questionnaires were mailed to members of the Macular Degeneration Partnership. The study was approved by an IRB and respondents provided consent before participating. Respondents' visual acuity (VA) was estimated using scores from the DLTV, while use of services and devices was collected from the AMD Questionnaire. De-identified data were analysed in SAS. RESULTS: Of 803 respondents, 56% were male and the mean age was 73 years. Use of services (e.g., counseling, rehabilitation), and devices significantly increased as VA decreased. Using standard US costs, costs for services, supplements, and devices ranged from 506-1619 US dollars depending on VA. CONCLUSION: There are substantial differences in service and device use with increased AMD severity. Delaying progression of AMD could result in considerable cost savings.

Smith CP, Sharma S, Steinle JJ. · Department of Physiology, School of Medicine, Southern Illinois University, 1135 Lincoln Drive, LS III Room 2071, Carbondale, IL 62901, USA. · Exp Eye Res. · Pubmed #17074321 No free full text.

Abstract: While age-related night vision loss and age-related macular degeneration are well characterized, less is known about the normal aging process in the retina and choroid. The purpose of this study was to ascertain whether dopamine beta-hydroxylase (DBH), beta1- and beta2-adrenergic receptor gene and protein expression are altered in the retina and choroid with age. The retina and choroid were dissected from F344xBNF1 hybrid rats aged 8, 22, and 32 months. Real-time PCR and Western blot analysis were conducted to determine steady-state mRNA and protein expression. Immunohistochemistry (IHC) was conducted to localize DBH protein expression in the retina. DBH protein expression was substantially decreased with age in the retina, particularly in the outer nuclear layer, with no changes in DBH expression noted in the choroid. There was a significant increase in beta1-adrenergic receptor protein expression in retinal samples at 22 months, while beta2-adrenergic receptor protein expression was not affected by age. Decreased expression of DBH with age in the retina could lead to reduced production of norepinephrine, potentially resulting in an increase of beta1-adrenergic receptor expression due to denervation supersensitivity. Gene expression for DBH, beta1- and beta2-adrenergic receptors were observed to peak at 22 months and return to baseline levels by 32 months of age in the choroid. Our findings suggest that the retina may be more sensitive to age-related loss of sympathetic neurotransmission than the choroid, which may partially explain normal age-related vision loss in the elderly.

Brown GC, Brown MM, Sharma S, Stein JD, Roth Z, Campanella J, Beauchamp GR. · Center for Value-Based Medicine, Flourtown, Pennsylvania, USA. · Trans Am Ophthalmol Soc. · Pubmed #17057801 links to  free full text

Abstract: PURPOSE: To assess the quality-of-life loss and the macroeconomic financial consequences associated with age-related macular degeneration (ARMD). METHODS: Time tradeoff utility analysis was performed to assess the quality-of-life diminution caused by ARMD (both dry and neovascular) in cohorts consisting of (1) patients with ARMD, (2) ophthalmologists asked to assume they had various degrees of severity of ARMD, (3) healthcare providers asked to assume they had various degrees of severity of ARMD, and (4) participants from the general community asked to assume they had various degrees of severity of ARMD. ARMD was classified according to vision in the better-seeing eye as (1) mild: 20/20 to 20/40, (2) moderate: 20/50 to 20/100, (3) severe: < or = 20/200, or (4) very severe: < or = 20/800. RESULTS: Mild ARMD caused a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate ARMD caused a 32% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or a fractured hip. Severe ARMD caused a 53% decrease in quality, more than that of dialysis, and very severe ARMD caused a 60% decrease in the average ARMD patient's quality of life, similar to that encountered with end-stage prostate cancer or a catastrophic stroke that leaves a person bedridden, incontinent, and requiring constant nursing care. Patients with varying degrees of severity of ARMD were found to have quality-of-life impairment ranging from 96% to 750% greater than that estimated by treating ophthalmologists for the same condition. An economic analysis based upon losses to the gross domestic product suggests that ARMD has approximately a $30 billion annual negative impact. The return on investment is therefore potentially high for both treatment with current ARMD therapies and the research costs invested in the development of new ARMD treatment modalities. CONCLUSIONS: ARMD is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.

Seddon JM, Sharma S, Adelman RA. · Epidemiology Unit, Department of Ophthalmology, Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts 02114, USA. · Ophthalmology. · Pubmed #16458093 No free full text.

Abstract: OBJECTIVE: To evaluate a clinical classification system, the Clinical Age-Related Maculopathy Staging (CARMS) system, for age-related maculopathy (ARM) using a simple grading scale designed for clinical practice and clinical research protocols. PARTICIPANTS: Two hundred forty-six male and female participants with various stages of ARM who were enrolled during the first 4 years of a longitudinal study were selected for the evaluation of the CARMS system. DESIGN: Cross-sectional comparison study. METHODS: The CARMS system divides patients into 5 mutually exclusive categories based on slit-lamp assessment of drusen, retinal pigment epithelial irregularities, geographic atrophy, retinal pigment epithelial detachment, and choroidal neovascularization. Fundus photographs and clinical data of the subjects were used to evaluate this scale. Clinical grades assigned for 492 eyes of 246 patients with varying stages of ARM were compared with grades obtained from photographs evaluated by a reading center. To compare grades obtained from an inexperienced grader with those of an experienced grader, observations based on photographs from 50 randomly selected patients were reviewed. To quantify intraobserver agreement for photographic grades, observations from one observer were compared with those made at a later date by the same observer. MAIN OUTCOME MEASURES: Reliability and validity of the CARMS system in grading various stages of ARM based on clinical examination and photography. RESULTS: The degree of overall agreement between the clinically assigned grade and photographic assessment for 492 eyes was substantial (exact overall agreement, 75%; unweighted kappa, 0.63; weighted kappa, 0.78). For advanced age-related macular degeneration, the sensitivity was 0.83, and specificity was 0.97. When assessing photographic grades, the degree of agreement between an inexperienced and an experienced grader was very high (unweighted kappa, 0.79; weighted kappa, 0.86), and the degree of intraobserver agreement was excellent (unweighted kappa, 0.92; weighted kappa, 0.97). CONCLUSIONS: The CARMS system, a 5-level clinical scale, is a valid and reliable staging system that can be used in both clinical practice and in clinical research protocols involving patients with all stages of ARM.

Blinder KJ, Shah GK, Thomas MA, Holekamp NM, Joseph DP, Grand MG, Sharma S. · Barnes Retina Institute, Washington University School of Medicine, St Louis, Missouri, USA. · Ophthalmic Surg Lasers Imaging. · Pubmed #16238033 No free full text.

Abstract: BACKGROUND AND OBJECTIVE: To describe the results of surgical treatment of peripapillary choroidal neovascularization in age-related macular degeneration as an option to both laser photocoagulation and photodynamic therapy. PATIENTS AND METHODS: Retrospective review of patients with peripapillary choroidal neovascularization secondary to age-related macular degeneration who were not eligible for or refused laser photocoagulation. Patients without the diagnosis of age-related macular degeneration and those who had extension of their neovascularization subfoveally were excluded from the review. RESULTS: Eleven patients total were identified who met the specified inclusion criteria. The male to female ratio was 4:7, with an age range of 63 to 94 years (mean = 78 years). The mean area of involved retina temporal to the optic disc was 5 clock hours, with the distance of the temporal edge of the lesion from the fovea ranging from 100 to 2,000 microm. The mean duration of follow-up was 23 months, with 27% (3 of 11) experiencing recurrent choroidal neovascularization. The preoperative and postoperative visual acuity ranges were both 20/25 to counting fingers. Sixty-four percent (7 of 11) of patients had stable or improved visual acuity postoperatively, with a mean visual acuity change of 1 line visual improvement. CONCLUSION: In cases where photodynamic therapy and laser photocoagulation are not indicated, the surgical treatment of peripapillary choroidal neovascularization secondary to age-related macular degeneration may prove beneficial.