Macular Degeneration: Virgili G

Giansanti F, Eandi CM, Virgili G. · Department of Neuro-Oto-Ophthalmological Surgical Sciences, Eye Clinic, University of Florence, Via le Morgagni 85, Florence, Italy, 50134. · Cochrane Database Syst Rev. · Pubmed #19370663 No free full text.

Abstract: BACKGROUND: Vitreoretinal surgeons proposed submacular surgery to remove the fibrovascular tissue causing damage to the centre of the retina, in the attempt to limit central visual loss in people affected by neovascular age-related macular degeneration (AMD). OBJECTIVES: This review aims at assessing the effectiveness of submacular surgery for preserving or improving vision in patients with AMD. SEARCH STRATEGY: We searched CENTRAL, MEDLINE, EMBASE and LILACS. There were no language or date restrictions in the search for trials. The electronic databases were last searched on 11 February 2009. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials comparing submacular surgery with any other treatment or observation. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. The risk ratio (RR) of visual loss and visual gain was estimated at one year. MAIN RESULTS: Two multicentre studies with a similar design were conducted between 1997 and 2003 and compared submacular surgery with observation in people affected by subfoveal neovascular AMD with (n=336) or without (n=454) extensive blood in the macula. At one year there was high quality evidence of no benefit for preventing visual loss (RR: 0.96; 95% confidence interval (CI): 0.84 to 1.09). No difference could be demonstrated regarding the chance of visual gain (RR: 1.06; 95% CI: 0.75 to 1.51), although this evidence was of low quality because of imprecision. The risk difference was -2% (95% CI: -10% to 5%) and 1% (95% CI: -4% to 6%) for visual loss and visual gain, respectively, thus excluding a large benefit with surgery in terms of absolute risk in this sample. There was high quality evidence that cataract needing surgery (RR: 8.69; 95% CI: 4.06 to 18.61) and retinal detachment (RR: 6.13; 95% CI: 2.81 to 13.38) were more common among operated patients, and detachment occurred in 5% of patients with no extensive blood and in 18% of those with extensive blood beneath the macula.A pilot study compared submacular surgery with laser photocoagulation in 70 patients. No difference between the two treatments could be demonstrated for any outcome measure, but estimates were very imprecise because of small sample size. AUTHORS' CONCLUSIONS: There is no benefit with submacular surgery in most people with subfoveal choroidal neovascularisation due to AMD in terms of prevention of visual loss. Furthermore, the risk of developing cataract and retinal detachment increases after surgery.

Eandi CM, Giansanti F, Virgili G. · Department of Clinical Physiopathology, Eye Clinic, University of Torino, Via Juvarra 19, Torino, Italy, 10122. · Cochrane Database Syst Rev. · Pubmed #18843739 No free full text.

Abstract: BACKGROUND: Macular translocation has been proposed by vitreoretinal surgeons to displace the neuroretinal tissue onto healthy retinal pigment epithelium and choroid when the macula has been invaded by subretinal neovascularisation. OBJECTIVES: This review aims at assessing the effectiveness of macular translocation for preserving or improving vision in patients with neovascular age-related macular degeneration (AMD). SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE and Caribbean Literature on Health Sciences (LILACS). There were no language or date restrictions in the search for trials.The electronic databases were last searched on 21 July 2008. SELECTION CRITERIA: We included randomised or quasi randomised controlled trials comparing macular translocation with any other treatment or observation. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. The risk ratio (RR) of visual loss and visual gain was estimated at one year after treatment. MAIN RESULTS: Only one small unblinded study on 50 people compared full macular translocation with photodynamic therapy (PDT) in AMD patients with predominantly classic subfoveal choroidal neovascularisation (CNV). At the last examination, performed in most of the cases after one year, there was no difference in the rate of visual loss of 3 or more lines (translocation versus PDT: RR 0.56, 95% confidence interval (CI) 0.22 to 1.43), as well as in the mean change of contrast sensitivity (1 letter favouring translocation; 95% CI -3.51 to 5.51) and the rate of recurrence of CNV (translocation versus PDT: RR 1.56, 95% CI 0.83 to 2.91). Other outcomes significantly favoured translocation, such as the gain of 3 or more ETDRS lines (RR 21, 95% CI 1.30 to 340.02), the mean change of visual acuity (mean difference (MD) 14.60, 95% CI 5.39 to 23.81) and the mean change of near visual acuity score (MD 17.80, 95% CI 3.98 to 31.62) which is obtained with an algorithm. Serious complications reported after macular translocation were retinal detachment in 6/25 patients and diplopia requiring prismatic correction in 5/25 patients. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials on the effectiveness of macular translocation, which is also not free of important risks. Furthermore, this technique is difficult to perform and a long surgical training is required. Future studies might include patients with small neovascular lesions that failed to respond to current pharmacological therapies and are willing to accept the risks associated with surgery to try to improve visual acuity.

Virgili G, Menchini F, Dimastrogiovanni AF, Rapizzi E, Menchini U, Bandello F, Chiodini RG. · Department of Ophthalmology, University of Florence, Florence, Italy. · Invest Ophthalmol Vis Sci. · Pubmed #17962446 links to  free full text

Abstract: PURPOSE: To review systematically the sensitivity and specificity of optical coherence tomography (OCT) for diagnosing macular edema attributable to diabetic retinopathy compared with well-established gold standard tests such as fundus stereophotography or contact and noncontact fundus biomicroscopy. METHODS: Medline and Embase were searched electronically and six major ophthalmic journals from 1998 to 2006 were hand searched. Two reviewers independently assessed trial searches, studied quality with the QUADAS (Quality Assessment of Diagnostic Accuracy Studies) checklist, and extracted data. The target disease was clinically significant macular edema (CSME) according to Early Treatment of Diabetic Retinopathy Study (ETDRS) criteria. A bivariate model was used to obtain summary estimates of sensitivity and specificity and fit a summary receiver operating characteristic (ROC) curve. RESULTS: Fifteen studies were considered eligible. These studies were of good quality for most items of the QUADAS checklist, but most studies did not report masking of examiners and did not describe how withdrawals and undetermined results were treated. Seven studies included healthy control subjects, which could have artificially enhanced OCT diagnostic performance. All but one study included both eyes of the patients without taking into account the within-subject correlation in statistical analyses. Sensitivity and specificity data could be extracted from only 6 of 15 studies, because appropriate cross tabulations of index and reference tests were not reported by the others. In five of these studies, central retinal thickness cutoffs between 230 and 300 microm were adopted to define abnormal OCT results and considered the central type of CSME only, whereas in one study a complex algorithm accounting for extrafoveal CSME was used. The design of one study was case-control and was excluded from the meta-analysis. The expected operating point on the summary ROC, a pooled estimate of all studies, corresponded to a sensitivity of 0.79 (95% CI: 0.71-0.86), a specificity of 0.88 (95% CI: 0.80-0.93), a positive likelihood ratio of 6.5 (95% CI: 4.0-10.7), and a negative likelihood ratio of 0.24 (95% CI: 0.17-0.32). These values suggest a good overall performance of OCT for diagnosing CSME. CONCLUSIONS: OCT performs well compared with fundus stereophotography or biomicroscopy to diagnose diabetic macular edema. The quality of reporting of such studies should be improved, and authors should present cross tabulations of index and reference test results. Data adjusted for within-subject correlation should also be provided, although this issue represents a challenge for systematic reviewers.

Virgili G, Bini A. · University of Florence, Department of Ophthalmology, Via le Morgagni 85, Florence, Italy, 50134. · Cochrane Database Syst Rev. · Pubmed #17636773 No free full text.

Abstract: BACKGROUND: Laser photocoagulation was the first treatment introduced to try to halt the progression of neovascular age-related macular degeneration (AMD), in which newly formed vessels or choroidal neovascularisation (CNV) grow under the macula leading to the occurrence of a scotoma or blind spot in the central visual field. OBJECTIVES: The aim of this review was to examine the effects of laser photocoagulation for neovascular AMD. SEARCH STRATEGY: We searched the CENTRAL, MEDLINE, EMBASE, LILACS, NRR and ZETOC in March 2007. SELECTION CRITERIA: We included randomised trials of laser photocoagulation in people with CNV due to AMD. DATA COLLECTION AND ANALYSIS: Two authors independently extracted the data. The risk ratio (RR) of severe visual loss (loss of six or more lines of visual acuity) was estimated at three months and two years after treatment. MAIN RESULTS: Fifteen trials were included in the review (2064 participants). Three types of photocoagulation were used in the trials: direct photocoagulation of the entire CNV (11 trials), perifoveal photocoagulation (one trial) and grid photocoagulation (three trials). In 12 trials the control group was observation only. One trial compared photocoagulation to submacular surgery and two trials compared different lasers. Data on the progression of visual loss could be extracted from five of the eight trials of direct photocoagulation of the CNV versus observation. The treatment effect was in the direction of harm in all studies at three months follow up (RR 1.41, 95% confidence intervals (CI) 1.08 to 1.82). After two years the treatment effect was in the direction of benefit (RR 0.67, 95% CI 0.53 to 0.83). These studies were clinically heterogeneous with participants having CNV lesions in different locations and different baseline visual acuities. There was little evidence of statistical heterogeneity at three months but substantial statistical heterogeneity at two years. However, all treatment effects in the individual trials were in the direction of benefit. One study comparing perifoveal photocoagulation or observation of subfoveal CNV found benefits that were statistically significant only at two years (RR 0.36, 95% CI 0.18 to 0.72). Other comparisons did not demonstrate differences. AUTHORS' CONCLUSIONS: In the medium to long term laser photocoagulation of CNV slows the progression of visual loss in people with neovascular AMD. However, it is associated with an increased risk of visual loss immediately after treatment and this period may be longer in people with subfoveal AMD. With the advent of modern pharmacological therapies, and concern for the impact of iatrogenic scotoma in subfoveal CNV, laser photocoagulation of subfoveal CNV is not recommended. No studies have compared photocoagulation with modern pharmacological agents for AMD for non-subfoveal CNV.

Virgili G, Do DV, Bressler NM, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Acta Ophthalmol Scand. · Pubmed #17244204 No free full text.

Abstract: During the past 20 years, several multicentre clinical trials have investigated different therapies for neovascular age-related macular degeneration (AMD). These landmark studies have provided the scientific community with powerful data regarding the ability of laser photocoagulation, verteporfin therapy, pegaptanib sodium and submacular surgery to treat particular choroidal neovascular lesion types. Accurate interpretation of data from these trials is essential to enable clinicians to make informed decisions about therapeutic interventions. Furthermore, several new treatment options are likely to become available in the next few years and clinicians will have to decide how effective these therapies may be, and how (or if) they should be used in clinical practice. It is therefore timely to review the strengths and weaknesses of the body of evidence for the currently available therapeutic options for patients with choroidal neovascularization due to AMD. Evaluation of the quality of reporting in past clinical trials will also enable critical review of new studies that will be published in the future. This review summarizes the design, reporting and results of key randomized clinical trials, in addition to evaluating the available evidence for new therapies and identifying the important issues that need to be considered when evaluating their efficacy.

Virgili G, Acosta R. · University of Florence, Eye Clinic II, Department of Oto-neuro-ophthalmological Surgical Sciences, Via le Morgagni 85, Florence, Italy. · Cochrane Database Syst Rev. · Pubmed #17054166 No free full text.

Abstract: BACKGROUND: The purpose of low vision rehabilitation is to allow people to resume or to continue to perform daily living tasks, reading being one of the most important. This is achieved by providing appropriate optical devices and special training in the use of residual vision and low vision aids, which range from simple optical magnifiers to high power video magnifiers. OBJECTIVES: The objective of this review was to assess the effects of reading aids for adults with low vision. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) in The Cochrane Library, MEDLINE, EMBASE, SIGLE, LILACS, IndMed to July 2006 and the reference lists of relevant articles. We used the Science Citation Index to find articles that cited the included studies and contacted investigators and manufacturers of low vision aids. We handsearched the British Journal of Visual Impairment from 1983 to 1999 and the Journal of Visual Impairment and Blindness from 1976 to 1991. SELECTION CRITERIA: This review included randomised and quasi-randomised trials in which any device or aid used for reading had been compared to another device or aid in people aged 16 or over with low vision as defined by the study investigators. DATA COLLECTION AND ANALYSIS: Each author independently assessed trial quality and extracted data. MAIN RESULTS: Eight small studies with a cross-over design (221 people overall) and one three parallel-arm study (243 participants) were included in the review. The cross-over studies evaluated various types of aids. The quality of the studies was unclear in most cases, especially concerning carry-over or period effects. In one study on 20 participants head-mounted electronic devices (four types) were worse than optical devices. We could not find any differences in comparisons among electronic devices when pooling 23 participants of two small studies. One study on 10 people found that overlay coloured filters were no better than a clear filter. A parallel-arm study including 243 patients with age-related macular degeneration found that custom or standard prism spectacles are not different from conventional near spectacles, but the estimated difference was not precise. AUTHORS' CONCLUSIONS: Further research is needed on the comparison of different types of low vision aids. It will be also necessary to delineate patient's characteristics that predict performance with costly electronic devices as well as their sustained use in the long term compared to simpler and cheaper optical devices.

Virgili G, Menchini F. · University of Florence, Eye Clinic II, Department Oto-Neuro-Ophthalmological Surgical Sciences, Via le Morgagni 85, Florence, Italy 50134. · Cochrane Database Syst Rev. · Pubmed #16235380 No free full text.

Abstract: BACKGROUND: Pathologic myopia is usually defined as the need for a spectacle correction of -6 diopters or higher. Choroidal neovascularisation (CNV) is the most commonly occurring cause of visual loss in people with pathologic myopia. In myopic macular degeneration the occurrence of newly formed vessels in the macula often leads to a fibrotic pigmented scar causing a blind spot in the centre of the visual field. OBJECTIVES: The primary objective of this review was to examine the effects of laser photocoagulation for CNV associated with pathologic myopia. A secondary objective was to compare the effects of different photocoagulation techniques. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) on The Cochrane Library (Issue 2, 2005), MEDLINE (1966 to July 2005), EMBASE (1980 to July 2005, week 28), LILACS (July 2005) and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials comparing photocoagulation with observation or comparing different photocoagulation techniques in people with CNV associated with myopia of -6 diopters or higher. DATA COLLECTION AND ANALYSIS: Two authors independently assessed the search results for eligibility. MAIN RESULTS: Two studies were included that enrolled people with CNV located at 100 microns or more from the foveal centre. One study compared photocoagulation with observation. At the final examination, 16/35 participants randomised to photocoagulation versus 31/35 randomised to observation had visual acuity of 20/100 or worse after 6 to 48 months. The second study randomised 27 eyes (26 patients) to photocoagulation with three laser wavelengths (9 eyes per group). The number of eyes losing two or more lines was 2 (577 nm), 3 (590 nm) and 3 (620 nm) after 3 to 17 months. In both studies comparisons were made using outcomes assessed at the final examination. As the final examination took place at different follow-up times it was difficult to interpret the findings and it was impossible to extract data for further analyses. AUTHORS' CONCLUSIONS: Despite its use over several years the effectiveness of laser photocoagulation for myopic CNV has not been established. Although there was a suggestion of short-term effectiveness in one small study on non-subfoveal CNV the results were potentially biased. Observational studies suggest that the enlargement of the atrophic laser scar after laser treatment of non-subfoveal CNV could be a potentially vision-threatening long-term complication, even in eyes free of CNV recurrence.

Menchini U, Cappelli S, Virgili G. · Eye Clinic II, Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Italy. · Semin Ophthalmol. · Pubmed #15513469 No free full text.

Abstract: Diabetes is a risk factor for the development of cataracts. Studies have shown an increased risk of ocular complications in diabetics after cataract surgery, but modern surgical techniques have minimized them, leading to an overall good visual outcome. Macular edema before surgery is the most common condition that limits post-operative visual recovery. Thus, pre-operative laser treatment is needed. Photocoagulation of preproliferative or early proliferative diabetic retinopathy is also advisable, due to the increased risk of iris neovascularization or retinopathy progression after surgery.

Giansanti F, Virgili G, Bini A, Rapizzi E, Giacomelli G, Donati MC, Verdina T, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. · Eur J Ophthalmol. · Pubmed #17415697 No free full text.

Abstract: PURPOSE: To investigate the 6-month safety and clinical outcomes of intravitreal injections of bevacizumab administered to treat choroidal neovascularization secondary to age-related macular degeneration. METHODS: Twenty-seven patients underwent 1.25 mg intravitreal injections of bevacizumab at baseline. A similar intravitreal injection was administered to all eyes at 1 and 2 month follow-up visits. At baseline and at each follow-up visit (1, 2, 3, and 6 months), patients underwent best-corrected visual acuity (BCVA) measurement, fluorescein angiography, indocyanine green angiography, and optical coherence tomography. Laboratory testing, visual field analyses, and endothelial cell counts were performed at baseline and third and sixth months. RESULTS: At 3 months, the mean BCVA remained substantially stable at 20/100. Mean central retinal thickness (CRT) decreased from 373 to 279 microm (p<0.01). Mean lesion greatest linear dimension (GLD) decreased from 4087 to 3782 microns (p<0.01). At 6 months, mean BCVA slightly decreased from 20/100(-1) to 20/125(-3) (not significant, p=0.40). Mean CRT was still inferior to baseline (305 microm, p<0.01). Mean lesion GLD was 4186 microm, not different from baseline values (p=0.59), but superior to 3-month mean GLD (p<0.01). Significant visual field defects or endothelial cell losses were not detected at 3 and 6 months. Laboratory testing did not reveal any clinically significant deviations compared to baseline values. CONCLUSIONS: Intravitreal therapy using bevacizumab over 6 months showed stabilization of visual acuity and choroidal neovascularization activity; the safety data were convincing.

Bandello F, Brancato R, Menchini U, Virgili G, Lanzetta P, Ferrari E, Incorvaia C. · Department of Ophthalmology, University of Udine, Udine, Italy. · Semin Ophthalmol. · Pubmed #15487693 No free full text.

Abstract: PURPOSE: We misled to verify whether a panretinal photocoagulation (PRP) performed using low levels of ARGON laser energy (light PRP) has the same efficacy as a PRP performed in a conventional fashion using argon green wavelengths (classic PRP) in eyes with high-risk proliferative diabetic retinopathy (HRPDR). Furthermore, we misled to compare the session number performed and the side effects produced by the two techniques. METHODS: Sixty-five eyes with HRPDR of 50 consecutive patients were enrolled in a prospective randomized controlled trial. In eyes selected for light PRP, a very light biomicroscopic effect on the retina was obtained for each spot. In eyes assigned to classic PRP, each spot produced a white-yellow biomicroscopic effect. Mean follow-up was 22.4 months +/- 9.7 in the light PRP and 21.6 months +/- 9.3 in the classic PRP group (p = 0.727). RESULTS: The initial mean logMAR visual acuity (VA) in the light PRP group was 0.12 +/- 0.13 and in the classic PRP group 0.14 +/- 0.15 (p = 0.493). The final mean VA in the former was 0.18 +/- 0.25, and in the latter 0.27 +/- 0.30 (p = 0.231). Median power was 235mW (100-540mW) for light and 420mW (200-950mW) for classic PRP (p < 0.001). Regression of HRPDR at the end of the follow-up was obtained in 30/31 eyes (97%) treated with classic PRP and in 31/34 eyes (91%) treated with light PRP (p = 0.615). The total mean session number was 7.4 +/- 2.4 for light and 9.9 +/- 2.2 for the classic PRP group (p < 0.001). Complications were more frequent in the classic PRP group. CONCLUSIONS: The efficacy of Light PRP is similar to that of classic Light PRP in eyes with HRPDR. Light PRP is associated with fewer complications and allows the reduction of the number of treatment sessions.

Parodi MB, Virgili G, Evans JR. · Department of Ophthalmology, University of Udine, Piazzale Santa Maria della Misericordia, Udine, Italy, 33100. · Cochrane Database Syst Rev. · Pubmed #19588397 No free full text.

Abstract: BACKGROUND: Drusen are amorphous yellowish deposits beneath the sensory retina. People with drusen, particularly large drusen, are at higher risk of developing age-related macular degeneration (AMD). The most common complication in AMD is choroidal neovascularisation (CNV), the growth of new blood vessels in the centre of the macula. The risk of CNV is higher among patients who are already affected by CNV in one eye.It has been observed clinically that laser photocoagulation of drusen leads to their disappearance and may prevent the occurrence of advanced disease (CNV or geographic atrophy) associated with visual loss. OBJECTIVES: To examine the effectiveness and adverse effects of laser photocoagulation of drusen in AMD. SEARCH STRATEGY: We searched CENTRAL, MEDLINE and EMBASE on 14 November 2008. SELECTION CRITERIA: Randomised controlled trials (RCTs) of laser treatment of drusen in AMD in which laser treatment had been compared with no intervention or sham treatment. Two types of trials were included. Some trials studied one eye of each patient (unilateral studies); other studies recruited patients with bilateral drusen and randomised one eye to photocoagulation or control and the fellow eye to the other group. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data. We pooled data from unilateral and bilateral studies using a random-effects model. For the bilateral studies, we estimated the within-patient correlation coefficient from one study and assumed it was valid for the others. MAIN RESULTS: We found nine studies which randomised 2216 people: four unilateral trials, three bilateral trials and two trials that included both a unilateral and a bilateral study arm.Overall, the studies were of moderate quality. Only half of the trials reported adequate allocation sequence generation, allocation concealment and masking of visual acuity outcome assessors.Although two (of the nine) studies reported significant drusen disappearance at two years, photocoagulation did not appear to affect the development of CNV at two years follow up (nine studies, 1767 people followed up, odds ratio (OR) 1.04, 95% CI 0.71 to 1.51) or the loss of three or more lines of visual acuity (six studies, 1628 people followed up, OR 1.17, 95% CI 0.75 to 1.82). AUTHORS' CONCLUSIONS: The trials included in this review confirm the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, there is no evidence that this subsequently results in a reduction in the risk of developing CNV, geographic atrophy or visual acuity loss.

Donati MC, Virgili G, Bini A, Giansanti F, Rapizzi E, Giacomelli G, Menchini U. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Ophthalmologica. · Pubmed #18849633 No free full text.

Abstract: BACKGROUND: Intravitreal (IV) bevacizumab (Avastin(R), Roche), initially used for the off-label treatment of neovascular age-related macular degeneration (AMD), has extended itself to treat various ocular pathologies such as choroidal neovascularization not associated to AMD. METHODS: IV bevacizumab 1,25 mg (Avastin) was used in the treatment of choroidal neovascularization (CNV) in 6 eyes of 5 patients with angioid streaks. All cases had a history of photodynamic treatment (PDT) or laser treatment and all showed progressive worsening despite the use of these therapies. RESULTS: After injection patients were followed up at nearly 2-month intervals. IV Avastin was repeated in case of recurrence. Three eyes were treated combining PDT and IV Avastin. Cases were followed up for 7-14 months. All patients needed more IV injections. Five out of 6 eyes showed an improvement of BCVA and a slight reduction of leakage and size with FA. CONCLUSION: This small series suggests that IV Avastin might be useful in the treatment of CNV due to AS.

Chakravarthy U, Soubrane G, Bandello F, Chong V, Creuzot-Garcher C, Dimitrakos SA, Korobelnik JF, Larsen M, Monés J, Pauleikhoff D, Pournaras CJ, Staurenghi G, Virgili G, Wolf S. · Queen's University and Royal Victoria Hospitals, Belfast, UK. · Br J Ophthalmol. · Pubmed #16929063 No free full text.

Abstract: BACKGROUND: Until recently, only two options were available for the treatment of choroidal neovascularisation (CNV) associated with age related macular degeneration (AMD)-thermal laser photocoagulation and photodynamic therapy with verteporfin (PDT-V). However, new treatments for CNV are in development, and data from phase III clinical trials of some of these pharmacological interventions are now available. In light of these new data, expert guidance is required to enable retina specialists with expertise in the management of AMD to select and use the most appropriate therapies for the treatment of neovascular AMD. METHODS: Consensus from a round table of European retina specialists was obtained based on best available scientific data. Data rated at evidence levels 1 and 2 were evaluated for laser photocoagulation, PDT-V, pegaptanib sodium, and ranibizumab. Other treatments discussed are anecortave acetate, triamcinolone acetonide, bevacizumab, rostaporfin (SnET2), squalamine, and transpupillary thermotherapy. RESULTS: PDT-V is currently recommended for subfoveal lesions with predominantly classic CNV, or with occult with no classic CNV with evidence of recent disease progression and a lesion size <or=4 Macular Photocoagulation Study (MPS) disc areas (DA). The new classes of anti-angiogenic agents-namely, pegaptanib sodium and ranibizumab (the latter when peer reviewed phase III data become available) are recommended for subfoveal lesions with any proportion of classic CNV or occult with no classic CNV. For juxtafoveal classic CNV, PDT-V or anti-angiogenic therapy should be considered if the new vessels are so close to the fovea that laser photocoagulation would almost certainly extend under the centre of the foveal avascular zone. For all other well demarcated juxtafoveal lesions and for extrafoveal classic lesions, laser photocoagulation remains the standard treatment. Therapy should be undertaken within 1 week of the fluorescein angiogram on which the clinical decision to treat is based. At each follow up, fluorescein angiography should be performed and best corrected visual acuity measured as a minimum requirement. CONCLUSIONS: These recommendations provide evidence based guidance for the choice and use of non-surgical therapies for the management of neovascular AMD. Revisions of the recommendations may be required as new data become available.

Donati MC, Carifi G, Virgili G, Menchini U. · Eye Clinic, Department of Oto-Neuro-Ophthalmological Surgical Sciences, University of Florence, Florence, Italy. · Ophthalmologica. · Pubmed #16374046 No free full text.

Abstract: AIM: It was the aim of this study to evaluate the frequency of retinal angiomatous proliferation (RAP) and its association with specific clinical and angiographic characteristics in age-related macular degeneration (AMD). METHODS: A consecutive series of 126 newly diagnosed patients with exudative AMD was reviewed retrospectively. All underwent a complete ophthalmic examination, a red-free photograph and fluorescein angiography. Most patients (85/126) underwent indocyanine green choroidal angiography (ICGA). RAP was diagnosed when a connection between the retinal vasculature and the neovascular complex was recognized angiographically. RESULTS: Out of 126 patients with recent neovascular AMD, 17 had RAP (13.5%; 95% CI 8.1-20.7). The study eye of patients with RAP had more frequent hemorrhages (88.2 vs. 59.6%; p = 0.027), hard exudates (82.4 vs. 26.6%; p < 0.001), pigment epithelium detachment (64.7 vs. 23.8%; p = 0.001) and a hot spot in ICGA (70.6 vs. 22.1%; p < 0.001) with respect to the other forms of exudative AMD. Hemorrhages were more frequently superficial, multiple and within the edge of the lesion in the RAP group. Bilateral AMD was more common in the RAP group (70.6 vs. 38.0%; p = 0.011). No statistically significant differences were found regarding sex, age and visual acuity. CONCLUSION: RAP represents a common lesion in patients with neovascular AMD referred to a tertiary care clinic. The recognition of hemorrhages, hard exudates, pigment epithelium detachment or a hot spot in ICGA can assist a correct diagnosis.

Pece A, Sannace C, Menchini U, Virgili G, Galli L, Isola V, Brancato R. · Department of Ophthalmology, Hospital of Melegnano, Predabissi (MI), Italy. · Eur J Ophthalmol. · Pubmed #16329062 No free full text.

Abstract: PURPOSE: To assess whether fluorescein angiography (FA) alone without indocyanine green angiography (ICGA) can identify and localize occult choroidal neovascularization (CNV) in age-related macular degeneration (ARMD). METHODS: Seventy-nine eyes of 77 consecutive patients with occult CNV were evaluated independently by two skilled physicians at first with FA alone and then with FA combined with ICGA by fundus camera. RESULTS: The agreement between FA and ICGA was 73% and 68% for the two physicians (K=0.585 and 0.512, respectively). The first operator correctly identified 20/27 as plaque CNV; six had different sizes and locations. The second operator identified 25/30, with one mistaken for size and location. For focal CNV the first operator identified 34/39, and the second one 23/35. CONCLUSIONS: Comparing the FA results with ICGA, CNV was correctly identified in about 60% of cases. Therefore, ICGA should be considered an indispensable diagnostic test to identify the presence, the type, and the location of occult CNV.

Blinder KJ, Bradley S, Bressler NM, Bressler SB, Donati G, Hao Y, Ma C, Menchini U, Miller J, Potter MJ, Pournaras C, Reaves A, Rosenfeld PJ, Strong HA, Stur M, Su XY, Virgili G, Anonymous00153, Anonymous00154. · · Am J Ophthalmol. · Pubmed #12967792 No free full text.

Abstract: PURPOSE: To determine whether differences in baseline lesion size and visual acuity might explain differing results found in three different lesion compositions (predominantly classic, minimally classic, and occult with no classic) among three placebo-controlled, randomized clinical trials evaluating photodynamic therapy with verteporfin (Visudyne, Novartis AG), also termed verteporfin therapy, in patients with subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). METHODS: Exploratory analyses were conducted in patients with predominantly classic or minimally classic lesions at enrollment in the Treatment of AMD with Photodynamic Therapy (TAP) Investigation and in AMD patients with occult with no classic CNV in the Verteporfin In Photodynamic Therapy (VIP) Trial. Baseline characteristics of patients among these three lesion compositions were compared. In addition, multiple linear regression modeling was used to explore the effect of baseline lesion size, visual acuity, and lesion composition on mean change in visual acuity from baseline to 24 months. RESULTS: At baseline, the mean size of predominantly classic lesions (3.4 disk areas) was smaller than that of minimally classic (4.7 disk areas) and occult with no classic lesions (4.3 disk areas). In the multiple linear regression model of individual lesion compositions, there was a significant treatment-by-lesion-size interaction for minimally classic and occult with no classic lesions, but not for predominantly classic lesions. Interaction between treatment and baseline visual acuity was not significant for any lesion composition. Small verteporfin-treated lesions lost less vision than large verteporfin-treated lesions in each lesion composition. In the multiple linear regression model that included all lesion compositions, lesion size was a more significant predictive factor for the magnitude of treatment benefit than either lesion composition or visual acuity. Smaller (4.0 disk areas or less) minimally classic and occult with no classic lesions had similar visual acuity outcomes to those observed in predominantly classic lesions. CONCLUSIONS: Based on exploratory analyses, lesion size in the TAP Investigation and VIP Trial was an important predictor of the magnitude of treatment benefit with verteporfin therapy in occult with no classic and minimally classic lesion compositions. In patients with AMD, treating smaller rather than larger neovascular lesions, regardless of lesion composition, likely will result in a better level of visual acuity.

Menchini U, Giacomelli G, Cappelli S, Giansanti F, Romani A, Virgili G. · Department of Oto-Neuro-Ophthalmological Surgical Sciences, Eye Clinic II, University of Florence, Viale Morgagni 85, 50134 Florence, Italy. · Arch Ophthalmol. · Pubmed #12470159 No free full text.

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Menchini U, Brancato R, Virgili G, Pierro L. · Department of Ophthalmology, University of Udine, Italy. · Ophthalmic Surg Lasers. · Pubmed #10847501 No free full text.

Abstract: Stellate foveal retinoschisis is considered the hallmark of X-linked retinoschisis. We describe the finding of unilateral retinoschisis with stellate foveal appearance in 2 females with myopia who had no evidence of familial disease. Optical coherence tomography (OCT) and fluorescein angiography were obtained in both cases. Neither patient had a family history of low vision, night blindness, or retinal detachment. Visual acuity in the affected eyes was 20/50 and 20/25, respectively. Both fellow eyes had normal fundi, except for mild myopic changes. With OCT, widespread retinal splitting was detected at the posterior pole in the affected eyes, whereas the fellow eyes were normal. In one case, OCT showed that foveal retinoschisis represented the macular involvement of a flat inferior retinoschisis, although this was not clinically apparent. Macular retinoschisis with stellate foveal appearance may rarely be associated with pathologic myopia. OCT was useful to establish the true extension of these macular changes.