Preoperative fundoscopy versus optical coherence tomography to detect occult maculopathy during cataract surgery preassessment.

PURPOSE: To assess the proportion of maculopathy detectable only on optical coherence tomography (OCT) versus slit lamp indirect ophthalmoscopy (SLIO) during cataract assessment. METHODS: Population: Consecutive patients attending cataract assessments. DATA COLLECTION: All patients underwent OCT and SLIO. SLIO findings were recorded before reviewing OCT. Scans were examined to compare with recorded SLIO findings. PRIMARY OUTCOME: analyse the proportion of eyes with maculopathy missed by SLIO. SECONDARY OUTCOME: to assess the proportion of patients with maculopathy on OCT, the incidence of maculopathy in the fellow eye on OCT and proportion with cataracts too dense to allow SLIO or OCT. RESULTS: Six hundred twenty-six patients were enroled. Eighty (12.8%) had maculopathy detectable only on OCT which included: 26 (4.2%) epiretinal membrane (ERM), 25 (4%) dry age-related macular degeneration (AMD), 19 (3%) vitreomacular traction (VMT), 5 (0.8%) lamellar macular hole (LMH), 2 (0.3%) cystoid macular oedema (CMO) and 1 (0.2%) wet AMD. 166 (26.5%) had maculopathy on OCT, of which only 48 (7.7%) had known history of maculopathy. In fellow eyes, 29 (4.6%) had significant findings and 29 (4.6%) were unable to have SLIO or OCT due to dense cataract. CONCLUSIONS: A quarter of the patients had occult maculopathy. One-tenth of the occult maculopathy were missed without OCT, with ERM, dry AMD, VMT, LMH, CMO and wet AMD being the primary missed diagnosis. Less than 5% had occult maculopathy in fellow eye, and <5% had dense cataracts where neither SLIO nor OCT was not possible.

New Prospects for Retinal Pigment Epithelium Transplantation.

ABSTRACT: Retinal pigment epithelium (RPE) transplants rescue photoreceptors in selected animal models of retinal degenerative disease. Early clinical studies of RPE transplants as treatment for age-related macular degeneration (AMD) included autologous and allogeneic transplants of RPE suspensions and RPE sheets for atrophic and neovascular complications of AMD. Subsequent studies explored autologous RPE-Bruch membrane-choroid transplants in patients with neovascular AMD with occasional marked visual benefit, which establishes a rationale for RPE transplants in late-stage AMD. More recent work has involved transplantation of autologous and allogeneic stem cell-derived RPE for patients with AMD and those with Stargardt disease. These early-stage clinical trials have employed RPE suspensions and RPE monolayers on biocompatible scaffolds. Safety has been well documented, but evidence of efficacy is variable. Current research involves development of better scaffolds, improved modulation of immune surveillance, and modification of the extracellular milieu to improve RPE survival and integration with host retina.

Vitrectomy for full thickness macular hole developed during the course of anti-VEGF treatment of type 1 neovascular AMD.

PURPOSE: To report a case of treatment of a full-thickness macular hole, which appeared after 10 months of anti-VEGF treatment in neovascular age related macular degeneration (nAMD). METHODS: The patient was diagnosed as type 1 nAMD. The coexisting vitreomacular traction caused a full thickness macular hole after 10 months of treatment. PATIENTS: A 68-year-old woman treated with anti VEGF. RESULTS: Vitrectomy with the temporal inverted ILM flap technique succeeded in closing the hole. Further anti-VEGF treatment followed. CONCLUSION: FTMH is a rare complication or coexistence in nAMD. Vitrectomy and continuous anti-VEGF treatment might result in satisfactory anatomical and functional results.

LONG-TERM RESULTS OF AUTOLOGOUS RETINAL PIGMENT EPITHELIUM AND CHOROID TRANSPLANTATION FOR THE TREATMENT OF EXUDATIVE AND ATROPHIC MACULOPATHIES.

PURPOSE: To evaluate the long-term results of autologous retinal pigment epithelium (RPE) and choroid transplantation (RPE-choroid patch) for exudative and atrophic maculopathies. METHODS: Consecutive chart review of 120 eyes, which underwent RPE-choroid patch, from 2007 to 2017 for RPE atrophy or choroidal neovascular membrane secondary to exudative and hemorrhagic age-related macular degeneration, myopia, angioid streaks, and laser. Eyes were tested with best-corrected visual acuity (BCVA), reading ability, optical coherence tomography, fluorescein angiography and indocyanine green angiography, autofluorescence, and microperimetry. RESULTS: Eighty-eight eyes of 84 patients had complete data, with 2- to 10-year follow-up. Mean age was 71.9 ± 9.06 years. Mean preoperative and postoperative BCVA was 20/320 (1.2 ± 0.2 logMAR) and 20/200 (0.94 ± 0.36 logMAR), respectively (P = 0.009). Reading ability recovered in 43% of cases. Microperimetry showed central fixation. A gain of at least 15 letters was obtained in 40% of eyes. Integrity (P = 0.009) of external limiting membrane and higher preoperative BCVA (P = 0.001) predicted better final BCVA. Complications were retinal detachment (11.4%), macular atrophy (7%), subretinal hemorrhage (4.5%), epiretinal membrane (4.5%), recurrent choroidal neovascular membrane (4.5%), macular hole (3.4%), and cystoid edema (3%). CONCLUSION: Autologous RPE-choroid patch achieved long-lasting BCVA improvement and central fixation, in eyes with choroidal neovascular membrane and intact external limiting membrane. Atrophic maculopathies only obtained temporary visual benefit.

Evaluation of Transplanted Autologous Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium in Exudative Age-Related Macular Degeneration.

PURPOSE: To report the results after 4 years of follow-up in a previously presented first case of induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) sheet autologous transplantation using multimodal imaging. DESIGN: Follow-up of a single case. PARTICIPANT: A patient with exudative age-related macular degeneration and polypoidal choroidal vasculopathy. METHODS: Transplantation of an autologous iPSC-derived RPE cell sheet after removal of choroidal neovascularization (CNV) in September 2014. MAIN OUTCOME MEASURES: The function of the graft was assessed 4 years after surgery by color fundus photography, spectral-domain (SD) OCT, fluorescein angiography, indocyanine green angiography, and an adaptive optics (AO) retinal camera. RESULTS: At the 4-year follow-up, the transplanted autologous iPSC-derived RPE sheet had survived beneath the retina with slight expansion of the pigmented area and no adverse events. The outer nuclear layer above and adjacent to the graft showed acceptable thickness and an organized structure. Fluorescein angiography and SD OCT suggested the presence of vessel-like structures confined to the grafted area associated with the remaining trunk vessel of preoperative polypoidal choroidal vasculopathy but with no exudative changes. Visual acuity has been stable with no additional injections of anti-vascular endothelial growth factor agent. The choroidal volume at the graft site is relatively preserved when compared with the volume outside this site without RPE after removal of the CNV. Indocyanine green angiography revealed a preserved choriocapillaris around the iPSC-derived RPE sheet. Dark cell-like structures with a predominantly hexagonal arrangement were observed by AO imaging in an area located near the margin of the graft sheet. The average intercell distance was found to be stable over time. CONCLUSIONS: Thus far, the grafted iPSC-derived RPE sheet has survived for 4 years and seems to support photoreceptors and choroidal vessels. The morphologic characteristics of the RPE are observed at the transplant site.

RETINAL PIGMENT EPITHELIUM-CHOROID GRAFT WITH A PERIPHERAL RETINOTOMY FOR EXUDATIVE AGE-RELATED MACULAR DEGENERATION: Long-Term Outcome.

PURPOSE: To investigate the long-term outcome of autologous retinal pigment epithelium -choroid transplantation with a peripheral retinotomy for exudative age-related macular degeneration. METHODS: In a retrospective study, we selected all patients who underwent a retinal pigment epithelium-choroid transplantation from 2007 through 2013. Exclusion criteria were age <60 years, <12 months of follow-up, and retinal pigment epithelium-choroid graft for other diseases than age-related macular degeneration. The main outcome measure was best-corrected visual acuity converted into logarithm of the minimum angle of resolution. RESULTS: In this study, 81 patients were included with a mean follow-up of 38 months (SD = 19). Median best-corrected visual acuity improved from 1.30 logarithm of the minimum angle of resolution (20/400 Snellen) to 0.90 logarithm of the minimum angle of resolution (20/160 Snellen) 1 year after surgery (P < 0.001). A ≥3-line gain was achieved in 43 patients (53%) 1 year postoperatively and 37 patients (46%) preserved their visual gain until last visit. Of 4 patients with an 8-year follow-up, 3 patients had a ≥6-line gain at last visit. Severe complications were submacular hemorrhage (n = 8, 10%), macular hole (n = 6, 7%), and proliferative vitreoretinopathy (n = 3, 4%). CONCLUSION: Best-corrected visual acuity improved significantly after retinal pigment epithelium-choroid transplantation in patients with age-related macular degeneration and preservation of visual gain was possible in the long term.

Morphological changes in the diseased retina on a healthy choroid-retinal pigment epithelial complex after full macular translocation for exudative age-related macular degeneration.

PURPOSE: To describe the change in the retinal morphology after full macular translocation (FMT) for exudative age-related macular degeneration (AMD) and identify predictive factors for the visual outcome. METHODS: All patients who underwent FMT from December 2008 through July 2013 were selected. Exclusion criteria were FMT for other disease than AMD, age <60 years, <12 months of follow-up or no available images. Spectral domain optical coherence tomography, fundus autofluorescence, fluorangiography and indocyanine green angiography were evaluated. RESULTS: In total, 51 patients were included with a mean follow-up of 30 months. The presence of the external limiting membrane (ELM) was a significant predictor for a favourable visual outcome 1 year after FMT (OR = -0.30). Other significant predictive factors were the absence of intraretinal fluid (OR = 0.28) and the mixed choroidal neovascularization type (OR = -0.47), whereas nonresponders (OR = 0.41) and fibrotic lesions (OR = 0.35) were less likely to have a good visual function after surgery. CONCLUSION: Full macular translocation (FMT), that permits to relocate the diseased macula onto an area of unaffected retinal pigment epithelial and choroid, can restore the anatomy and visual function in some patients with AMD when the outer retina layers are not irreversibly damaged. The presence of the ELM seems to be the most reliable factor in predicting the functional outcome.

Subthreshold Nanosecond Laser Intervention in Age-Related Macular Degeneration: The LEAD Randomized Controlled Clinical Trial.

PURPOSE: There is an urgent need for a more effective intervention to slow or prevent progression of age-related macular degeneration (AMD) from its early stages to vision-threatening late complications. Subthreshold nanosecond laser (SNL) treatment has shown promise in preclinical studies and a pilot study in intermediate AMD (iAMD) as a potential treatment. We aimed to evaluate the safety of SNL treatment in iAMD and its efficacy for slowing progression to late AMD. DESIGN: The Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study is a 36-month, multicenter, randomized, sham-controlled trial. PARTICIPANTS: Two hundred ninety-two participants with bilateral large drusen and without OCT signs of atrophy. METHODS: Participants were assigned randomly to receive Retinal Rejuvenation Therapy (2RT®; Ellex Pty Ltd, Adelaide, Australia) SNL or sham treatment to the study eye at 6-monthly intervals. MAIN OUTCOME MEASURES: The primary efficacy outcome was the time to development of late AMD defined by multimodal imaging (MMI). Safety was assessed by adverse events. RESULTS: Overall, progression to late AMD was not slowed significantly with SNL treatment compared with sham treatment (adjusted hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.33-1.14; P = 0.122). However, a post hoc analysis showed evidence of effect modification based on the coexistence of reticular pseudodrusen (RPD; adjusted interaction P = 0.002), where progression was slowed for the 222 participants (76.0%) without coexistent RPD at baseline (adjusted HR, 0.23; 95% CI, 0.09-0.59; P = 0.002), whereas an increased progression rate (adjusted HR, 2.56; 95% CI, 0.80-8.18; P = 0.112) was observed for the 70 participants (24.0%) with RPD with SNL treatment. Differences between the groups in serious adverse events were not significant. CONCLUSIONS: In participants with iAMD without MMI-detected signs of late AMD, no significant difference in the overall progression rate to late AMD between those receiving SNL and sham treatment were observed. However, SNL treatment may have a role in slowing progression for those without coexistent RPD and may be inappropriate in those with RPD, warranting caution when considering treatment in clinical phenotypes with RPD. Our findings provide compelling evidence for further trials of the 2RT® laser, but they should not be extrapolated to other short-pulse lasers.

Effect of Phacoemulsification on Visual Acuity and Macular Morphology in Patients with Wet Age-Related Macular Degeneration.

BACKGROUND This article discusses the effectiveness of phacoemulsification cataract surgery with intraocular lens implantation in patients with wet age-related macular degeneration in the inactive phase of the disease. MATERIAL AND METHODS Forty-nine patients (50 eyes) aged 78.94±5.54 years, previously treated with intravitreal injections of anti-vascular endothelial growth factor agents, were qualified for a prospective, randomized 12-month study. The participants were divided into 2 groups. Group I consisted of 25 patients (25 eyes) who were subjected to phacoemulsification cataract surgery. Group II consisted of 24 patients (25 eyes) who were not subjected to phacoemulsification cataract surgery despite having a lens opacity of grade II or higher according to the Lens Opacities Classification System. RESULTS After 12 months of follow-up, patients in group I gained on average 8.04 letters (p<0.001). Furthermore, 20% of the eyes had a significant improvement in best corrected visual acuity of ≥15 Early Treatment of Diabetic Retinopathy Study Chart letters. Patients in group II lost on average 1.96 letters (p>0.05). No significant differences between central retinal thickness values in either group (p>0.05) were noted. The mean number of intravitreal injections of anti-vascular endothelial growth factor agents during the study was 2.64±1.98 in group I and 2.92±2.40 in group II (p>0.05). CONCLUSIONS Phacoemulsification performed in eyes with wet age-related macular degeneration during the inactive phase of the disease significantly improves visual acuity. In addition, it does not significantly influence the frequency of intravitreal injections of anti-vascular endothelial growth factor agents or disease activity.

COMBINED AUTOLOGOUS TRANSPLANTATION OF NEUROSENSORY RETINA, RETINAL PIGMENT EPITHELIUM, AND CHOROID FREE GRAFTS.

PURPOSE: To evaluate the feasibility and initial functional and anatomical outcomes of transplanting a full-thickness free graft of choroid and retinal pigment epithelium (RPE), along with neurosensory retina in advanced fibrosis and atrophy associated with end-stage exudative age-related macular degeneration with and without a concurrent refractory macular hole. METHODS: During vitrectomy, an RPE-choroidal and neurosensory retinal free graft was harvested in nine eyes of nine patients. The RPE-choroidal and neurosensory retinal free graft was either placed subretinally (n = 5), intraretinally to cover the foveal area inside an iatrogenically induced macular hole over the RPE-choroidal graft (n = 3) or preretinally (n = 1) without a retinotomy wherein both free grafts were placed over the concurrent macular hole. Silicone oil endotamponade was used in all cases. RESULTS: Mean follow-up was 7 ± 5.5 months (range 3-19). The mean preoperative visual acuity was ∼count fingers (logarithm of the minimum angle of resolution = 2.11, range 2-3), which improved to ∼20/800 (logarithm of the minimum angle of resolution 1.62 ± 0.48, range 0.7-2, P = 0.04). Vision was stable in 5 eyes (55.6%) and improved in 4 eyes (44.4%). Reading ability improved in 5 eyes (55.6%). Postoperative complications were graft atrophy (n = 1), epiretinal membrane (n = 1), and dislocation of neurosensory retina-choroid-RPE free graft (n = 1). CONCLUSION: Combined autologous RPE-choroid and neurosensory retinal free graft is a potential surgical alternative in eyes with end-stage exudative age-related macular degeneration, including concurrent refractory macular hole.

Laser photocoagulation as treatment of non-exudative age-related macular degeneration: state-of-the-art and future perspectives.

PURPOSE: To give an updated review of laser approaches to non-exudative age-related macular degeneration (AMD). METHODS: PubMed and Medline database searches were carried out using the terms "laser" and "photocoagulation" associated with "age-related macular degeneration", and latest publications up to May 2017 have been reviewed. Moreover, the design of an ongoing single-center, non-randomized, phase I-II, pilot study, the PASCAL-GA trial, coordinated by F. Bandello, MD and G. Querques, MD from the IRCCS Ospedale San Raffaele, is described. RESULTS: Either standard or subthreshold laser strategies have been tried to induce regression of distinct phenotypes of AMD, as reticular pseudodrusen (RPD), nascent geographic atrophy (nGA), and drusen-associated geographic atrophy (DAGA), with heterogeneous results. The aim of the PASCAL-GA protocol is to assess if subthreshold laser can restore the retinal pigment epithelium function in eyes with RPD and nGA offering a protective effect against extensive GA. CONCLUSIONS: New-generation medical and surgical approaches, including subthreshold laser photocoagulation, may have some success in downstaging AMD.

Intraocular lenses in age-related macular degeneration.

PURPOSE: The aim of this work is to review the lenses, assessing their advantages and disadvantages. We describe a total of seven types of intraocular lenses (IOLs) recommended for age-related macular degeneration (AMD). METHODS: We used the PubMed web platform to search for implantable devices in various stages of AMD. We searched for both prospective and retrospective studies and also case reports. RESULTS: Clinical results in AMD patients have been described for a total of seven types of IOLs recommended for AMD: an implantable miniature telescope (IMT), IOL-VIP System, Lipshitz macular implant (LMI), sulcus-implanted Lipshitz macular implant, LMI-SI, Fresnel Prism Intraocular Lens, iolAMD and Scharioth Macula Lens. CONCLUSIONS: We conclude that to objectively ascertain the effectiveness and safety of these lenses, further independent clinical studies with longer follow-up data are necessary prior to the general use of these optical devices.

OCT angiography documented reperfusion of translocated autologous full thickness RPE-choroid graft for complicated neovascular age-related macular degeneration.

PurposeThe purpose of this study is to investigate the reperfusion of translocated retinal pigment epithelium (RPE)-choroid graft in the treatment of patients with neovascular age-related macular degeneration (nAMD), using OCT angiography (OCTA), a novel non-invasive, high-resolution imaging modality.Patients and methodsEighteen eyes of 18 consecutive patients suffering from complicated nAMD underwent RPE-choroid patch graft translocation surgery using a peripheral retinotomy and flap-over technique. We analyzed functional and anatomical outcome using visual acuity, Spectral Domain OCT and OCTA.ResultsWith a mean follow-up of 11 months, out of 18 patients, 15 gained vision, 1 remained stable, and 2 lost vision. Overall, the visual acuity improved with a mean of 30 letters. Perfusion of the graft tissue was confirmed in all patients. Two patients developed signs of a recurrent neovascular membrane during follow-up. No cases of proliferative vitreoretinopathy occurred in this series.ConclusionsOCTA images show signs of perfusion in all grafts. Encouraging functional results and low risk of severe complications suggest that RPE-choroid graft translocation is a valid option in patients with complicated nAMD.

Long-term results after limited macular translocation surgery for wet age-related macular degeneration.

PURPOSE: To evaluate the long-term results of limited macular translocation (LMT) surgery with radial chorioscleral outfolding in patients with wet age-related macular degeneration (AMD) and subfoveal choroidal neovascularization (CNV). In addition, to identify the factors associated with the final best-corrected visual acuity (BCVA). METHODS: The medical records of 20 eyes of 20 consecutive patients (65.2±9.8 years) who had undergone LMT for the treatment of wet AMD and were followed for at least 5 years, were reviewed. The surgical outcomes including the BCVA, degree of foveal displacement, and complications were recorded. RESULTS: The mean foveal displacement was 1332 ± 393 µm after the LMT. The CNV was removed in 16 eyes and photocoagulated in 4 eyes. The mean preoperative VA was 0.83 ± 0.33 logMAR units which significantly improved to 0.59 ± 0.37 logMAR units at 1 year after the surgery (P = 0.015). This BCVA was maintained at 0.59 ± 0.41 logMAR units on the final examination. The final BCVA was significantly correlated with that at 1 year after the surgery (r = 0.83, P<0.001). Multiple linear regression analysis showed that the final BCVA was significantly correlated with the BCVA at 1 year after the surgery (P<0.001), a recurrence of a CNV (P = 0.001), and the age (P = 0.022). CONCLUSIONS: LMT improves the BCVA significantly at 1 year, and the improved BCVA lasted for at least 5 years. These results indicate that the impaired function of the sensory retina at the fovea can recover on the new RPE after the displacement for at least 5 years. The ability to maintain good retinal function on the new RPE for a long period is important for future treatments of CNVs such as the transplantation of RPE cells and stem cells.

[PHACOEMULSIFICATION IN EYES WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (AMD)].

INTRODUCTION: Age-related macular degeneration (AMD) is the leading cause of blindness in the western world. The debate continues over the safety of cataract surgery in the setting of neovascular (wet) AMD. This retrospective review aims to describe our experience in treating patients with wet AMD, who underwent cataract surgery by phacoemulsification. METHODS: We prepared a retrospective chart review of patients treated in our clinic between the years 2006 - 2013. RESULTS: Forty-two eyes of 38 patients were included. Visual acuity (VA) improved significantly 1 month after cataract removal, without a significant change in retinal thickness. Twenty-six patients (62%) needed anti-VEGF injections during follow-up after surgery within an average period of 6 months. In eyes that were dry preoperatively, the re-injection rate was lower than those that were still wet (56 % vs. 80%) and the time from surgery to the first injection was longer in dry eyes (7 months and 3 months, respectively). Eyes that were injected with anti-VEGF up to one week before surgery had greater improvement in VA immediately after surgery but the proportion of those receiving injections (78%) was greater and the time to first injection post-surgery was earlier (3 months) compared to eyes that received the last injection 6 months or more prior to surgery ( 53 % and - 7 months). CONCLUSIONS: Cataract removal improves vision in wet AMD patients. It is of great importance to treat these patients and try to reach dry retina prior to surgery and a close followup is needed after surgery. In eyes that were more stable within 6 months before surgery and their retina was dry, the re-injection rate post surgery was lower and the time to first injection was longer.

LOW ENDOPHTHALMITIS RATES AFTER INTRAVITREAL ANTI-VASCULAR ENDOTHELIAL GROWTH FACTOR INJECTIONS IN AN OPERATION ROOM: A Retrospective Multicenter Study.

PURPOSE: To evaluate the rate of presumed endophthalmitis (EO) after intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in three European hospitals performed in an operation room (OR) under sterile conditions. METHODS: A retrospective multicenter study between 2003 and 2016 at three European sites, City Hospital Triemli Zurich, Switzerland (CHT), Zealand University Hospital Roskilde, Denmark (ZUH) and University Clinic Bern, Switzerland (UCB). Intravitreal injection (IVI) database of each department was reviewed. All anti-vascular endothelial growth factor injections were performed using a standardized sterile technique in an operation room. Injection protocols were similar between the three sites. No preinjection antibiotics were given. Postoperative antibiotics varied among sites. RESULTS: A total of 134,701 intravitreal injections were performed at the 3 sites between 2003 and 2016. Ten cases of presumed endophthalmitis were documented: 4 in 50,721 at CHT (95% CI: 0.0071-0.0087%), 2 in 44,666 at ZUH (95% CI: 0.0039-0.0051%), and 4 in 39,314 at UCB (95% CI: 0.0092-0.011%). This results in one case in 13,470 intravitreal injections and a combined incidence of 0.0074% per injection (95% CI: 0.0070-0.0078%). Positive cultures were found in 4 out of 10 presumed endophthalmitis cases. CONCLUSION: The standardized sterile technique in an operation room with laminar airflow showed very low rates of endophthalmitis at three European sites.

A comparison of autologous transplantation of retinal pigment epithelium (RPE) monolayer sheet graft with RPE-Bruch's membrane complex graft in neovascular age-related macular degeneration.

PURPOSE: To compare the outcome after choroidal neovascular (CNV) membrane excision and retinal pigment epithelium (RPE) transplantation and make further evaluation of two types of RPE grafts on the visual function in patients with neovascular age-related macular degeneration (AMD), complicated by massive subretinal haemorrhage. METHODS: We retrospectively reviewed 80 patients who underwent CNV membrane excision with or without RPE transplantation. Two types of RPE grafts were adopted, RPE-Bruch's membrane complex graft (subgroup 1) and RPE monolayer sheet graft (subgroup 2). Outcome measures included pre- and postoperative visual acuity score (VAS), clinical findings, complications and recurrence rates. RESULTS: The mean VAS [Early Treatment of Diabetic Retinopathy Study (ETDRS)] in the CNV membrane excision group was 11.06 ± 18.28 at baseline and 14.41 ± 16.86 at follow-up (p = 0.12) in a mean follow-up period of 24.35 ± 9.31 months. While in subgroup 1, VAS increased from 22.62 ± 23.72 to 35.50 ± 24.46 (p = 0.02) in a mean period of 20.63 ± 6.25 months. The percentage of visual acuity (VA) improvement (at least two or more lines changed) in subgroup 1 is 62.5%, which is significantly higher than that in CNV excision group (23.5%), p = 0.02. In subgroup 2, VAS increased from 16.61 ± 27.98 to 29.16 ± 23.80 (p = 0.02) in a mean period of 21.72 ± 11.09 months. The percentage of VA improvement in subgroup 2 is 58.0%, which is also significantly higher than that in CNV excision group (23.5%), p = 0.02. Postoperative VA elevation was comparable between the two subgroups (p = 0.05). Complications including retinal detachment, proliferative vitreal retinopathy and CNV recurrence occurred in both techniques. Central fixation stability was observed in eight eyes in subgroup 1 and five eyes in subgroup 2. CONCLUSIONS: The autologous RPE transplantation can increase the vision of patients with haemorrhagic AMD. Two types of autologous RPE grafts were both effective and comparable in restoring visual function and central fixation stability.

StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial.

BACKGROUND: The standard of care for neovascular age-related macular degeneration (nAMD) involves ongoing intravitreal injections of anti-angiogenic drugs targeting vascular endothelial growth factor (VEGF). The most commonly used anti-VEGF drugs are ranibizumab, bevacizumab and aflibercept. The main objective of the STAR trial is to determine if stereotactic radiotherapy can reduce the number of anti-VEGF injections that patients with nAMD require. METHODS/DESIGN: STAR is a multicentre, double-masked, randomised, sham-controlled clinical trial. It evaluates a new device (manufactured by Oraya, Newark, CA, USA) designed to deliver stereotactic radiotherapy (SRT) to nAMD lesions. The trial enrols participants with chronic, active nAMD. Participants receive a single SRT treatment (16 Gy or sham) with a concomitant baseline intravitreal injection of 0.5 mg ranibizumab. Thereafter, they attend every month for 24 months, and ranibizumab is administered at the visit if retreatment criteria are met. The primary outcome is the number of pro re nata ranibizumab injections during the first 24 months. Secondary outcomes include visual acuity, lesion morphology, quality of life and safety. Additional visits occur at 36 and 48 months to inspect for radiation retinopathy. The target sample size of 411 participants (randomised 2:1 in favour of radiation) is designed to detect a reduction of 2.5 injections against ranibizumab monotherapy, at 90% power, and a significance level (alpha) of 0.025 (one-sided two-sample t test). This gives 97% power to detect non-inferiority of visual acuity at a five-letter margin. The primary analyses will be by intention to treat. DISCUSSION: The safety and efficacy outcomes will help determine the role of SRT in the management of chronic, active nAMD. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN12884465. Registered on 28 November 2014. ClinicalTrials.gov: NCT02243878 . Registered on 17 September 2014.

Follow-up after surgery for hemorrhagic AMD.

INTRODUCTION: The long-term functional results of macular hematoma (MH) surgery in exudative AMD are often limited. The goal of this study was to compare visual outcomes of monthly versus bimestrial follow-up in these patients. METHODS: Retrospective, interventional case series. Population : 21 eyes of 21 patients with SMH associated with exudative AMD. INCLUSION CRITERIA: first SMH associated with exudative AMD, with 1-year postoperative follow-up. EXCLUSION CRITERIA: blood located exclusively underneath the retinal pigment epithelium on OCT imaging, SMH due to different etiology, lost to follow-up, ≤5 postoperative visits and a different surgical protocol as described. Patients were divided into two groups according to the number of postoperative visits (number of intravitreal injections [IVT] combined with the number of consultations, only one visit was recorded when IVT and consultation occurred on the same day) during the 1-year postoperative follow-up: group 1 had ≥11 visits (n=8); group 2 had 6 to 10 visits (n=13). All eyes underwent vitrectomy with subretinal injection of recombinant tissue plasminogen activator, fluid-gas exchange and anti-VEGF intravitreal injection. The main outcome was change in best-corrected visual acuity (BCVA). RESULTS: Considering visual acuity (VA) change between 1-month and 1-year postoperative follow-up examinations, group 1 had statistically significant greater VA changes (logMAR -0.29±0.44 vs logMAR 0.42±0.73; P=0.016; P=0.016). In patients that had exudative recurrences (ER), group 1 received more anti-VEGF IVT than group 2 (P=0.045). CONCLUSION: Our results showed that monthly follow-up, between the IVT series, is highly recommended to preserve postoperative VA in patients undergoing surgery for SMH associated with AMD.

COMBINED VITRECTOMY AND INTRAVITREAL DEXAMETHASONE (OZURDEX) SUSTAINED-RELEASE IMPLANT.

PURPOSE: To evaluate the safety and efficacy of combining intravitreal dexamethasone implantation (Ozurdex) with pars plana vitrectomy (PPV). METHODS: A retrospective review was conducted on cases where Ozurdex injection was performed in the operating room in conjunction with pars plana vitrectomy. Our primary outcome measure was the presence of surgical complications in the perioperative and 3-month postoperative window. We also measured visual acuity, intraocular pressure (IOP), and macular edema at baseline, one, and 3 months after surgery. RESULTS: Fifteen eyes in 14 cases were reviewed. There were no complications intraoperatively or at 1-month postoperatively. Two patients (2 eyes) with prior retinal detachment developed proliferative vitreoretinopathy and redetachment at 3 months. Visual acuity improved in 7 of 15 eyes, and an average improvement of 2 lines was achieved for the entire cohort. There was no overall change in intraocular pressure although 1 patient developed an increase in intraocular pressure >5 mmHg. Five of 9 patients with baseline macular edema experienced improvement or resolution at 3 months. CONCLUSION: Intraoperative Ozurdex in combination with PPV may be safe and effective in treating macular edema caused by many different underlying diseases.