Macular Degeneration: Smiddy WE

Smiddy WE. · The Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. · Curr Opin Ophthalmol. · Pubmed #18408493 No free full text.

Abstract: PURPOSE OF REVIEW: This article reviews the current status of treatments for age-related macular degeneration from a cost-effectiveness perspective. RECENT FINDINGS: Treatments are now available to a broad range of patients with age-related macular degeneration, but they are pharmaceutical based and require repeated evaluation and treatment. The resulting unprecedented levels of cost make cost-effectiveness considerations more prescient. Newer methods to evaluate cost-effectiveness and treatment outcomes have included utility and value-based analyses. These have attempted to utilize accurate, objective parameters, but are calibrated by subjective patient assessments and are limited by certain methodological assumptions. Treatment methods to improve outcomes are increasingly being considered within the context of cost-effectiveness. SUMMARY: Although improved understanding of basic, cellular processes has led to markedly improved treatment options for age-related macular degeneration within the past decade, the high costs and wide applicability threaten the balance and viability of the payor system. Accurate means of assessing cost-effectiveness are critical to defining clinical applications.

Smiddy WE. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. · Ophthalmology. · Pubmed #17306878 No free full text.

Abstract: PURPOSE: To quantitate the relative cost of new therapies for age-related macular degeneration (AMD) versus saved vision. DESIGN: Systematic review. METHODS: Landmark AMD treatment studies were reviewed to quantitate the visual benefit. For comparison, representative treatment studies for common retinal conditions including retinal detachment, macular hole (MH), epiretinal membrane (ERM), and diabetic retinopathy were also reviewed. MAIN OUTCOME MEASURES: Several parameters to estimate Snellen lines of vision saved were defined and tabulated for each condition. A regimen of office visits, ancillary testing, and treatments was outlined. Costs for this were tabulated using Medicare-allowable costs, and costs of visual benefit (per line of vision) for each condition were calculated. Life expectancy was factored in to calculate the cost of a line of vision for each year (line-year). The proportions of costs allocated to professional, technical, and pharmaceutical expenses were tabulated for each therapy. RESULTS: The cost per line of vision saved for AMD therapies ranged from $997 for laser for extrafoveal choroidal neovascularization, to $5509 for photodynamic therapy for occult lesions, to $12 482 for pegaptanib injections. This compares to $651 for retinal detachment repair, $1658 for MH repair, $2411 for ERM peeling, $5458 for diabetic macular edema laser, $594 for panretinal photocoagulation, and $2984 to $4178 for diabetic vitrectomy. The costs per line-years ranged from $77 to $1248 for AMD, and $21 to $194 for the comparison conditions. The proportion of costs for pegaptanib treatment was 17% for professional fees and 70% for pharmaceutical fees. Assumptions incorporated in estimating costs for pegaptanib could easily have doubled because second-year costs might approximate first-year costs and the maintenance of treatment effect has not been well established. CONCLUSIONS: Although correctly heralded as a breakthrough in macular degeneration treatment, new pharmacologic therapies for AMD are extremely expensive and some yield marginal visual dividends. As in all fields of medicine that provide care to elderly patients, these costs should be considered as they relate to health care costs for the individual patient and payors, and must be considered in a larger perspective of health care benefit apportionment.

Smiddy WE, Flynn HW. · Department of Ophthalmology, University of Miami School of Medicine, Bascom Palmer Eye Institute, Miami, Florida 33101, USA. · Am J Ophthalmol. · Pubmed #15013877 No free full text.

Abstract: PURPOSE: To review the literature and identify consistencies and inconsistencies in existing theories of pathogenesis and to consider some of their possible therapeutic implications. DESIGN: Presentation of clinical case material with a synthesis of ideas on macular holes. METHODS: The literature of macular hole surgery is reviewed pertinent to pathogenic theories. Clinical examples of evolving macular holes shown on ocular coherence tomography are presented to illustrate issues. RESULTS: The history of pathogenesis and macular holes is interesting in that, in many ways pathogenic theory has come full cycle. Initially, anteroposterior traction was thought to cause direct formation of a macular hole. Subsequently, degenerative and then tangential tractional etiologies were proposed. Current imaging studies have greatly advanced our understanding of anatomic features of full-thickness holes and early full-thickness hole conditions. These are most consistent with a focal anteroposterior traction mechanism, but some inconsistences in clinical cases suggest a role for degeneration of the inner retinal layers. CONCLUSIONS: Degeneration of the inner retinal layers at the central fovea may predispose the eye to macular hole formation. What may otherwise be incidental tractional forces appear to initiate the hole. These tractional elements are oriented perpendicularly to the retinal surface, rather than tangentially. Further observations, especially with sequential observations from ocular coherence tomography, may yield further insights into the pathogenesis of macular holes as well as implications regarding the best repair techniques.

Gregori NZ, Gaitan J, Rosenfeld PJ, Puliafito CA, Feuer W, Flynn HW, Berrocal AM, Al-Attar L, Dubovy S, Smiddy WE, Schwartz SG, Lee WH, Murray TG. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 900 NW 17th St., Miami, FL 33136, USA. · Retina. · Pubmed #19430392 No free full text.

Abstract: PURPOSE: To evaluate the long-term safety and efficacy of intravitreal bevacizumab injections (Avastin, Genentech Inc., San Francisco, CA) for the treatment of macular edema secondary to central retinal vein occlusions. METHODS: A retrospective review was performed of eyes treated from May 2005 to August 2006 with follow-up through February 2007. The dose of bevacizumab was 1.25 mg (0.05 mL). Retreatment was performed at monthly or longer intervals at the discretion of the treating physician. RESULTS: Fifty-seven eyes received intravitreal bevacizumab at baseline. Visual acuity improved by a mean of 14 letters (N = 53; P < 0.001) at 1 month, 13 letters at 3 months (N = 53; P < 0.001), 9 letters at 6 months (N = 30; P = 0.001), 9 letters at 12 months (N = 17; P = 0.004). The mean optical coherence tomography thickness decreased by 299 microm at 1 month (N = 53; P < 0.001), 144 microm at 3 months, (N = 53; P < 0.001), 127 microm at 6 months (N = 30; P = 0.011), and 276 microm at 12 months (N = 17; P < 0.001). No ocular or systemic adverse events were observed. CONCLUSION: Improvements in visual acuity and optical coherence tomography were observed during the first year following intravitreal bevacizumab for macular edema secondary to central retinal vein occlusions. These retrospective results provide additional evidence to support the perceived safety and efficacy of intravitreal bevacizumab in this disorder.

Smiddy WE. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida 33136, USA. · Ophthalmology. · Pubmed #19157562 No free full text.

Abstract: PURPOSE: To measure the cost versus benefit of age-related macular degeneration (AMD) treatment strategies, existing and proposed, in the postranibizumab era. DESIGN: Cost-effectiveness model. PARTICIPANTS: None. METHODS: University with hospital-based practice modeling of clinical examination, imaging, and treatment schedules were constructed considering published protocols where available, or by estimating usual practices. Medicare-allowable reimbursement schedules for a hospital-based, south Florida practice in 2007 were used to calculate costs of treatment. The lines of vision saved were deduced from published reports or using identified assumptions. This information was used to calculate cost per lines saved and, using actuarial tables data, costs per line-year saved were calculated. MAIN OUTCOME MEASURE: Cost ($US) per line-year. RESULTS: Consensus control values of expected lines loss if untreated (natural history) were established from published reports (2.5 lines at 1 year; 3.5 at 2 years) and photodynamic therapy (2.0 lines at 1 year; 3.0 at 2 years) for use in calculating lines of vision saved in studies without untreated control groups. The cost per line-year for 1 year of treatment ranged from a low of $84 with as-needed bevacizumab to $766 for protocol-style use of ranibizumab. Combination treatment regimens yielded a range of $71 to $269. The pharmaceutical proportion of treatment costs is higher than professional or facility costs, ranging to 83% for protocol-style ranibizumab. CONCLUSIONS: Pharmaceutical-based treatments of AMD have markedly improved visual outcomes, but also have escalated costs markedly. Treatment regimens involving as-needed dosing, alternate medications, and combination therapy may preserve benefit for substantially lower costs. Disparate safety profiles would require consideration in choosing treatment regimens. Cost-benefit issues must be considered in AMD treatment regimens.

Hartley KL, Smiddy WE, Flynn HW, Murray TG. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami, Miller School of Medicine, Florida, USA. · Retina. · Pubmed #18327132 No free full text.

Abstract: PURPOSE: To evaluate anatomic and visual acuity (VA) results of pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling for diffuse diabetic macular edema (DME), and to review the literature on the topic. METHODS: Retrospective noncomparative case series of patients who underwent PPV with ILM peeling for diffuse DME between January 1, 2000, and December 1, 2005, performed by three surgeons at Bascom Palmer Eye Institute. Main outcome measures included pre- and postoperative optical coherence tomography (OCT) and visual acuity. Mean follow-up period was 8 months (range, 43 days-2 years). RESULTS: Twenty-four eyes of 23 patients meeting the criteria were evaluated. Duration of DME ranged from 1 to 93 months. Mean preoperative logMAR vision was 0.782 (range, 0.30-1.82). Mean logMAR visual acuity at final follow-up was 0.771 (range, 0.10-2.00). At last follow-up, 25% of eyes had > or =2 line increase in VA from baseline, 54% of eyes had no improvement in VA, and 21% of eyes had > or =2 line decrease in VA. Of 9 eyes with pre- and postoperative OCT, there was an overall reduction in central macular thickness of 141 microm at postoperative month 3 and 120 microm at last follow-up. Postoperative complications included progression of cataract in 6 (60%) of 10 phakic eyes, postoperative intraocular pressure > or =30 mmHg in 6 (24%) eyes, and postoperative vitreous hemorrhage in 2 (8%) eyes. CONCLUSIONS: Pars plana vitrectomy with ILM peeling was associated with a reduction in DME when measured by OCT in the majority of eyes, but visual acuity outcomes showed minimal improvement compared to baseline. These results suggest the efficacy of PPV with ILM peeling for eyes with DME has not been well established and should be reserved for therapy with selected cases.

Gregori NZ, Rosenfeld PJ, Puliafito CA, Flynn HW, Lee JE, Mavrofrides EC, Smiddy WE, Murray TG, Berrocal AM, Scott IU, Gregori G. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida 33136, USA. · Retina. · Pubmed #17031288 No free full text.

Abstract: PURPOSE: To evaluate the safety and efficacy of intravitreal triamcinolone acetonide (IVTA) as treatment for macular edema associated with central retinal vein occlusion (CRVO). METHODS: A retrospective review was performed of data for 40 consecutive patients (40 eyes) with CRVO and macular edema treated with IVTA at the Bascom Palmer Eye Institute (Miami, FL). RESULTS: Median duration of symptoms before the first injection was 3 months (range, 1 day to 8 years). Median Snellen visual acuity was 20/400 at baseline (range, 20/60 to light perception; n = 40), 20/300 at 1 month (P = 0.010; n = 37), 20/300 at 3 months (P = 0.007; n = 33), 20/400 at 6 months (P = 0.726; n = 28), and 8/200 at 1 year (P = 0.569; n = 17). Vision improved by > or =3 lines in 21% of eyes at 1 month, 27% at 3 months, 14% at 6 months, and 12% at 1 year. Visual acuity was unchanged from baseline in 71% of eyes at 6 months and 1 year. By 1 year, 50% of eyes received more than one injection (mean = 1.6 injections; range 1-4 injections). Overall, intraocular pressure increased by > or =10 mmHg in 24% of eyes at 1 year. Trabeculectomy was performed on 2 of 12 eyes with preexisting open-angle glaucoma. CONCLUSION: IVTA can substantially improve vision in some patients, but most patients have stable visual acuity compared with baseline at 1 year despite repeated injections.

Tabandeh H, Smiddy WE, Sullivan PM, Monshizadeh R, Rafiei N, Cheng L, Freeman W. · Department of Ophthalmology, University of Florida, Gainesville, Florida, USA. · Retina. · Pubmed #15492624 No free full text.

Abstract: PURPOSE: To study the characteristics and outcomes of choroidal neovascularization (CNV) developing after surgery for idiopathic macular holes. METHODS: Retrospective, noncomparative case series. Search of diagnostic and procedure databases of four participating institutes identified nine eyes of eight patients with CNV after surgery for idiopathic macular hole. Demographic, clinical, and fundus fluorescein angiographic data were abstracted from patients' medical records. RESULTS: Choroidal neovascularization developed 6 weeks to 30 months after macular hole surgery. The macular hole was closed in all cases. The CNV complex involved the foveal region in 9 (100%) eyes, was predominantly classic in 8 (89%) eyes, and was associated with moderate to severe leakage of fluorescein in 8 (89%) eyes. The CNV was crescent-shaped and spared the central area of retinal pigment epithelial mottling that corresponded to the site of the macular hole in 6 (67%) cases. Other fluorescein angiographic features included retinal pigment epitheliopathy in 6 (67%) eyes and presence of drusen in 7 (78%) eyes. The final visual acuity after a mean follow-up period of 11.2 months (range, 3-16 months) was 20/50 to 20/80 in 2 (22%) eyes, 20/100 to 20/200 in 1 (11%) eye, and less than 20/200 in 6 (67%) eyes. CONCLUSION: Choroidal neovascular complexes occurring after macular hole surgery tend to share certain characteristics, including foveal involvement, frequent sparing of the central area corresponding to the site of the closed macular hole, and generally poor visual outcomes. Therapeutic modalities including photodynamic therapy and surgical options may be considered in these patients.

Pinto RV, Smiddy WE, Culbertson W. · Instituto Mineiro De Olhos Belo Horizonte, Minas Gerais, Brazil. · Ophthalmic Surg Lasers Imaging. · Pubmed #14750767 No free full text.

Abstract: Two cases of choroidal neovascularization occurring after laser in situ keratomileusis (LASIK) are presented from two separate centers. In the first case, an extrafoveal choroidal neovascular membrane, apparently associated with age-related macular degeneration, occurred 3 months after a LASIK procedure was performed on a 64-year-old man with hyperopia. Argon laser treatment and subsequent photodynamic therapy were performed and resulted in stabilization of vision. The second case involved neovascularization 3 weeks following a LASIK procedure for myopia, apparently associated with the myopia. No treatment was recommended and the vision stabilized at 20/50. Although the cause is not clear, careful preoperative macular evaluation and attention to symptoms that might herald the presence of choroidal neovascularization are recommended for patients undergoing LASIK.

Moore JK, Scott IU, Flynn HW, Smiddy WE, Murray TG, Kim JE, Vilar NF, Pereira MB, Jorge R. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida, USA. · Ophthalmology. · Pubmed #12689890 No free full text.

Abstract: PURPOSE: To investigate the incidence and outcomes of retinal detachment (RD) associated with retained lens fragments removed by pars plana vitrectomy (PPV). DESIGN: Retrospective, noncomparative, interventional consecutive case series. PARTICIPANTS: All patients who underwent PPV for retained lens material after cataract surgery at Bascom Palmer Eye Institute between January 1, 1990, and December 31, 2001. METHODS: Demographic and clinical data were extracted from patients' medical records. MAIN OUTCOME MEASURES: Incidence of retinal detachment, reattachment rate, and visual acuity outcome. RESULTS: RD occurred in 44 of 343 (12.8%) patients, including 25 (7.3%) before or during PPV and 19 (5.5%) after PPV. The RD was macula-on in 22 of 44 (50%) patients and macula-off in 22 of 44 (50%) patients. The RD was associated with a giant retinal tear in 7 of 44 (15.9%) patients, limited suprachoroidal hemorrhage in 3 of 44 (6.8%) patients, and endophthalmitis in 4 of 44 (9.1%) patients. Retinal reattachment was achieved in 40 of 44 (90.9%) patients; 14 of 44 (31.8%) patients underwent one or more additional procedures for recurrent detachment. Final visual acuity in the patients in this series was >/=20/40 in 8 of 44 (18%), 20/50 to 20/100 in 13 of 44 (30%), 20/200 to 5/200 in 13 of 44 (30%), and <5/200 in 10 of 44 (23%). In the 36 patients with vision less than 20/40, the primary causes of decreased vision were attributed to prior history of RD in 8 of 36 (22.2%), corneal edema in 7 of 36 (19.4%), cystoid macular edema in 5 of 36 (13.9%), persistent retinal detachment in 4/36 (11.1%), preexisting primary open-angle glaucoma in 4 of 36 (11.1%), age-related macular degeneration in 3 of 36 (8.3%), epiretinal membrane in 2 of 36 (5.5%), macular hole in 1 of 36 (2.7%), optic atrophy in 1 of 36 (2.7%), and irregular astigmatism in 1 of 36 (2.7%) patients. CONCLUSIONS: RD is a frequent complication in eyes undergoing PPV for removal of retained lens fragments. Despite favorable retinal reattachment rates, visual acuity outcomes are often poor in these eyes and are associated with other comorbidities such as corneal edema and cystoid macular edema. Poor initial visual acuity and the presence of a retinal tear at the time of PPV were associated with a higher rate of RD after PPV.

Benz MS, Smiddy WE. · Bascom Palmer Eye Institute, University of Miami School of Medicine, Miami, Florida 33101, USA. · Ophthalmic Surg Lasers Imaging. · Pubmed #12570009 No free full text.

Abstract: Intraoperative use of indocyanine green to stain the internal limiting membrane assists in its visualization and removal. This article describes increased uptake of diode laser energy by the superficial layers of the retina after indocyanine green staining of the internal limiting membrane in a patient with diabetic macular edema and a taut, attached posterior hyaloid. The patient was undergoing pars plana vitrectomy, removal of the posterior hyaloid, and indocyanine green-assisted peeling of the internal limiting membrane. In addition, panretinal diode laser endophotocoagulation was performed after discovering retinal neovascularization. In areas that were more intensely stained with indocyanine green, the clinical appearance and optical coherence tomography scans demonstrated markedly increased laser energy uptake in the superficial layers of the retina. This case indicates near-infrared or infrared laser procedures performed in areas of indocyanine green-stained internal limiting membrane may necessitate adjustment of laser power and technique.