Brolucizumab effectiveness in pigment epithelium detachment due to exudative AMD in naïve treatment or non-responder patients.

PURPOSE: To investigate outcomes after Brolucizumab injection in naïve treatment or non-responder patients with exudative age-related macular degeneration (AMD). METHODS: It is a retrospective, comparative, cohort study conducted at the tertiary referral center of the University Hospital Polyclinic of Bari, for 5 years, from November 2017 until May 2022. 41 eyes with wet-AMD (w-AMD) were included, undergoing anti-vascular endothelial growth factor (VEGF) intravitreal injections. The sample was divided into two groups, the Bro-Switch group, and the Bro-Naïve group. The Bro-Switch group previously received a slot of other anti-VEGF intravitreal drugs. The Bro-Naïve group received Brolucizumab (Bro) as the first treatment. The pigment epithelium detachment (PED) and the best-corrected visual acuity (BCVA) outcomes before and after Bro-injection were evaluated. RESULTS: A significant reduction in PED measurement was registered in all eyes treated with Bro-injection (p = 0.35). The Bro-Naïve group improved better in PED measurement (mean difference: 297.92 ± 72,32) as compared to the Bro-Switch group (mean difference: 185.06 ± 11.07). On the contrary, no significant reduction in BCVA in the two groups was recorded (p = 0.66). CONCLUSION: We suggest Bro-injection for w-AMD as effective anatomical outcomes in PED flattening, but not similar in visual results. Although this study evaluated short-term outcomes, the hopeful results can lead to interesting medium-long time effects.

OCT-angiography follow-up of choroidal neovascularization treated with treat-and- extend aflibercept regimen to avoid over-treatment.

PURPOSE: To propose optical coherence tomography angiography (OCT-A) for the follow-up of neovascular age-related macular degeneration (nAMD) treated with a treat-and-extend (T&E) aflibercept regimen to avoid overtreatment. METHODS: Retrospective, cohort, pilot study. We analysed 16 consecutive-treatment naïve nAMD eyes following up 2-years at the Eye Clinic, Bari, Italy. Intravitreal aflibercept injections in the T&E regimen for no less than 12 months, during which the macula was dry without any sign of intraretinal or subretinal fluid (SRF) at each visit, were performed. Parametric data were evaluated using an analysis of variance (ANOVA); any non-parametric statistical calculations were performed using the Wilcoxon and Mann-Whitney test. RESULTS: The average number of injections during follow-up was: 8.8 ± 1. Treatment regimen adjustments were 4 weeks (W), 8W (4 + 4), 10W (8 + 2), 12W (8 + 4, or 10 + 2). No significant CNV size change from 4 to 8W (-0.027 ± 0.22 mm², p = 0.088), and from 8 to 12W (-0.04 ± 0.11 mm², p = 0.065) were found. Likewise, no significant decrease in choriocapillaris flow (CF) was detected (p = 0.056). CONCLUSION: We suggest that OCT-A may be useful in the evaluation of dry macula to decide the best approach for perchance adjusting injection intervals based on changes of CNV size.

Dexamethasone intravitreal implant along with femtosecond laser assisted cataract surgery in patients with diabetic macular edema and cataract.

PURPOSE: To assess the safety and efficacy of intraoperative dexamethasone intravitreal (DEX) implant in patients with diabetic macular edema (DME) undergoing femtosecond laser assisted cataract surgery (FLACS). METHODS: In this single-center retrospective study, the charts of patients who underwent combined FLACS and DEX implant in the previous three months were reviewed. Primary outcome measures were ocular complications; secondary outcome measures were the change of best-corrected visual acuity (BCVA) and central retinal thickness (CRT). RESULTS: 20 eyes of 20 patients were included. None developed intraoperative or postoperative complications. Mean BCVA was 20/120 (logMAR, 0.78 ± 0.31) at baseline and improved significantly to 20/63 (logMAR, 0.52 ± 0.24; p = 0.01), 20/58 (LogMAR, 0.48 ± 0.28; p < 0.001) and to 20/58 (LogMAR, 0.48 ± 0.31; p < 0.001) at month 1,2 and 3, respectively. A mean improvement of 0.30 LogMAR was recorded at month 1 and 3. Mean CRT decreased significantly from 416.6 ± 76.1 µm at baseline to 322.4 ± 46.4 µm (p < 0.001), to 300.7 ± 29.7 µm (p < 0.001), and to 319.8 ± 54.7 µm (p < 0.001) at month 1,2 and 3, respectively. Comparing to the 1-month follow-up, the largest mean reduction in CRT (112.4 ± 68.9 µm) was observed at month 2 (p = 0.001). Fourteen patients (70%) had an improvement of CRT over the first 2 months followed by a recurrence of edema at month 3. CONCLUSION: DEX implant following FLACS seems to be a safe and effective approach for patients with coexisting cataract and DME.

Microvascular changes in the recurrent cystoid macular edema secondary to posterior noninfectious uveitis on optical coherence tomography angiography.

BACKGROUND: Posterior uveitis represents the second most frequent type of uveitis (15-30% of all uveitis). Noninfectious posterior uveitis complicated with secondary cystoid macular edema (CME) affects the visual prognosis negatively. The objective of the current study is to detect possible microvascular changes causing relapsing uveitis-related CME using optical coherence tomography angiography (OCTA). METHODS: This is an interventional, observational, retrospective study with 1 year follow-up. Patients with noninfectious, posterior uveitis-related CME undergoing dexamethasone (DEX) implant were evaluated. Following the DEX-implant were carried out control visits after 1 month, 2-months, 4-months, 6-months, and for up 1-year. A total of 76 eyes of 38 consecutive patients with noninfectious posterior uveitis were enrolled (consecutive sample). Complicated noninfectious posterior uveitis with secondary CME was diagnosed in 56 eyes of uveitis patients (73.7%) and reviewed. RESULTS: Our investigation showed (1) a reduction in superficial vessel plexus (SVP) measurements within 2-month (84%), reaching 96.4% for up 1-year, (2) an irregular profile of SVP in 69.6% of cases, persisting for up 1-year; relapsing uveitis-related CME eyes with irregular superficial foveal avascular zone (FAZ) profile were in 51%, while the SVP measurements reestablished in 100% of cases. Conversely, (3) the deep vascular plexus (DVP) parameters restored in a lower number of eyes within the 2-month (39.3%), remaining abnormal in 46.4% of cases for up 1-year; despite DVP restored in 53.6% of cases for up 1 year, (4) a capillary rarefaction ring around the FAZ appeared in 80.4% of cases; the relapsing uveitis-related CME eyes with abnormal DVP parameters were present in 41% of cases, of which 92.1% showed a rarefaction ring had abnormal DVP. CONCLUSIONS: The use of OCTA enabled the evaluation in detail of retinal microvascular changes. We suggested that the possibility of the recurrence of the uveitis-related CME depends on the persistence of modifications of the superficial and deep layers. In this regard, we propose to implement the current imaging armamentarium with OCTA for the follow-up of patients with noninfectious uveitis-related CME.

Frequency of Intravitreal Anti-VEGF Injections and Risk of Death: A Systematic Review with Meta-analysis.

TOPIC: To investigate whether an increasing number of intravitreal anti-VEGF injections is associated with a higher mortality risk. CLINICAL RELEVANCE: The issue of systemic safety of intravitreal anti-VEGF therapy has been long discussed. Evidence from meta-analyses of randomized studies has shown no increased risk of mortality in the overall population, whereas some warning signals of higher mortality were found in patients with diabetes exposed to intense and prolonged treatment. Concerns have been raised about whether an increasing number of anti-VEGF injections could be associated with a higher mortality. METHODS: Randomized clinical trials enrolling arms with different intensities of anti-VEGF therapy were searched. The primary outcome measure was the incidence rate ratio (IRR) of death with 95% confidence interval (CI) for receiving 5 injections. The relationship between the number of injections and all-cause mortality was investigated. Separate regression analyses were conducted to investigate this relationship in subgroups of studies with different diseases and drugs. RESULTS: Fifty-two trials were included. Overall mortality rates of 1.02% and 3.36% were recorded at 12 and 24 months, respectively. Univariate regression showed that a larger number of injections was not associated with a significant increase in mortality both at 12 months (IRR, 1.16; 95% CI, 0.87-1.53; P = 0.31) and at 24 months (IRR, 1.05; 95% CI, 0.95-1.15; P = 0.34). According to subgroup analyses, in diabetic macular edema (DME) studies, a higher risk was marginally associated with an increasing number of injections at 24 months (IRR, 1.17; 95% CI, 1.02-1.33; P = 0.03). CONCLUSION: No significant influence of anti-VEGF treatment intensity on mortality was shown, supporting a message of reassurance over safety concerns of this therapy. Marginal evidence of a higher risk associated with a more intense treatment was found in patients with DME.

Intravitreal dexamethasone implant versus anti-vascular endothelial growth factor therapy combined with cataract surgery in patients with diabetic macular oedema: a systematic review with meta-analysis.

OBJECTIVE: To compare outcomes of cataract surgery combined with either anti-Vascular Endothelial Growth Factor (anti-VEGF) therapy or dexamethasone implant (DEX) in patients with diabetic macular oedema (DMO). METHODS: Pubmed and Embase databases were searched for studies reporting outcomes of diabetic cataract surgery combined with either anti-VEGF or DEX, with a follow-up ≥3 months. The primary outcome was the mean change in central macular thickness (CMT). Mean change in best corrected visual acuity (BCVA) was considered as a secondary outcome. The mean difference between baseline and post-treatment values (MD) with 95%-Confidence Interval (95%CI) was calculated and meta-analyses were performed. RESULTS: Nine-teen studies were included, 8 in the DEX group and 11 in the anti-VEGF group. A significant reduction of macular thickness was shown in the DEX group at 3 months (MD = -98.35 µm; 95% CI, -147.15/-49.54), while mean CMT change was non-significant in the anti-VEGF group (MD = -21.61 µm; 95% CI, -59.46/16.24; test of group differences, P < 0.001). At 3 months, no difference in visual gain was found between the two groups (P = 0.13). CONCLUSIONS: In DMO patients, cataract surgery combined with DEX seems to provide better anatomical outcomes compared with cataract surgery combined with anti-VEGF therapy. However, our evidence was limited by significant heterogeneity. Randomised trials comparing these two different combined approaches are warranted.

Comparison of perioperative parameters in one-handed rotational phacoemulsification versus conventional phacoemulsification and femtosecond laser-assisted cataract surgery.

AIM: To compare perioperative parameters of one-handed rotational phacoemulsification technique (one-handed phaco-roll) with each of other two techniques, "Divide et Conquer" and femtosecond laser-assisted cataract surgery (FLACS). METHODS: In this retrospective and comparative cohort study, eyes with uncomplicated cataract (nuclear density grade 2 to 3) treated routinely with one-handed phaco-roll (n=23; Group 1) or "Divide et Conquer" (n=23; Group 2) or FLACS (n=23; Group 3) were enrolled. Intraoperative parameters including effective phaco-time (EPt), ultrasound time (USt), aspiration time, surgical time, phacoemulsification (phaco)-power, balanced salt solution (BSS) use, cumulative dissipated energy (CDE) were recorded and compared. Clinical outcomes including best corrected visual acuity (BCVA), corneal endothelial cell density (ECD), endothelial cell loss (ECL), central corneal thickness (CCT) and central macular thickness (CMT), were assessed and compared pre-operatively and at 1mo after surgery. RESULTS: Aspiration and surgical time, and BSS used were lower in Group 1 (P<0.01) than other groups. EPt, phaco-power and CDE were lower in Group 1 (P<0.05) than Group 2 but not significantly different from Group 3. In Group 1, USt was lower (P<0.05) than Group 2 but higher (P<0.05) than Group 3. BCVA improved in all groups without significant difference between Group 1 and the other ones. No significant differences regarding all post-operative morphologic outcomes (ECD, ECL, CCT, CMT) were reported. No clinical complications occurred. CONCLUSION: One-handed phaco-roll seems to be less time-consuming than "Divide et Conquer" and FLACS and less energy-consuming than "Divide et Conquer". Furthermore, one-handed phaco-roll seems to have an equal safety profile compared to the other two techniques.

Visual functional changes after ocriplasmin injection for vitreomacular traction: A microperimetric analysis.

PURPOSE: The purpose is to evaluate functional changes after ocriplasmin injection to treat vitreomacular traction (VMT) by microperimetry. MATERIALS AND METHODS: Prospective interventional study on patients underwent an intravitreal ocriplasmin injection. Optical coherence tomography, best-corrected visual acuity (BCVA) test, and microperimetry were performed at baseline, 1 week, 1 and 3 months. Microperimeter recorded retinal sensitivity (RS) and central retinal sensitivity (CRS) at central 12° and 4°, respectively, and fixation as bivariate contour ellipse area (BCEA) at 68%, 95%, and 99% of fixation points. Functional parameters were analyzed in patients who had (Group A) or not (Group B) VMT release. RESULTS: Twenty-one patients including 18 with VMT and 3 with VMT plus macular hole (MH) were treated. Eleven patients achieved VMT resolution including all cases with MH that achieved hole closure. An impairment of BCVA, RS and CRS (P < 0.01; P < 0.001; P = 0.001, respectively) was reported at 1 week followed by a significant improvement (BCVA, P = 0.001; RS, CRS, P = 0.02) at 3 months. The early impairment of visual acuity and sensitivity significantly occurred in Group B (P ≤ 0.01) while their recovery significantly occurred in Group A (P < 0.01). BCEA significantly increased in dimension (68%, P = 0.01; 95%, P = 0.03) at 1 week, subsequently returning to near baseline values over follow-up. Only in Group A, fixation stability significantly improved at 3 months. CONCLUSION: Microperimetry confirms an early and reversible functional impairment after ocriplasmin injection regardless VMT resolution. If a greater decrease in function could occur in the eyes without VMT resolution, a better functional recovery could occur in the event of VMT resolution.

Effectiveness of anti-vascular endothelial growth factors in neovascular age-related macular degeneration and variables associated with visual acuity outcomes: Results from the EAGLE study.

OBJECTIVE: To assess the overall effectiveness of anti-vascular endothelial growth factor (VEGF) therapy in treatment-naïve patients with neovascular age-related macular degeneration (nAMD) in a clinical practice setting. STUDY DESIGN: EAGLE was a retrospective, 2-year, cohort observational, multicenter study conducted in Italy that analyzed secondary data of treatment-naïve patients with nAMD. The primary endpoint evaluated the mean annualized number of anti-VEGF injections at Years 1 and 2. The main secondary endpoints analyzed the mean change in visual acuity (VA) from baseline and variables associated with visual outcomes at Years 1 and 2. RESULTS: Of the 752 patients enrolled, 745 (99.07%) received the first dose of anti-VEGF in 2016. Overall, 429 (57.05%) and 335 (44.5%) patients completed the 1- and 2-year follow-ups, respectively. At baseline, mean (standard deviation, SD) age was 75.6 (8.8) years and the mean (SD) VA was 53.43 (22.8) letters. The mean (SD) number of injections performed over the 2 years was 8.2 (4.1) resulting in a mean (SD) change in VA of 2.45 (19.36) (P = 0.0005) letters at Year 1 and -1.34 (20.85) (P = 0.3984) letters at Year 2. Linear regression models showed that age, baseline VA, number of injections, and early fluid resolution were the variables independently associated with visual outcomes at Years 1 and 2. CONCLUSIONS: The EAGLE study analyzed the routine clinical practice management of patients with nAMD in Italy. The study suggested that visual outcomes in clinical practice may be improved with earlier diagnosis, higher number of injections, and accurate fluid resolution targeting during treatment induction.

Perfluorocarbon liquid-assisted inverted inner limiting membrane-flap for large macular hole after recurrent rhegmatogenous retinal detachment.

A 45-year-old Caucasian myopic woman with a severe vision impairment (20/320) in the left eye due to a macula-off rhegmatogenous retinal detachment (RRD) underwent vitrectomy with silicone oil tamponade followed by an inferior relaxing retinectomy with heavy silicone oil tamponade during the second procedure for recurrence of RRD due to proliferative vitreoretinopathy. Four weeks after the second surgery, visual acuity was 20/200 and the patient complained metamorphopsia in the same eye due to a large full-thickness macular hole. A perfluorocarbon liquid-assisted inverted inner limiting membrane-flap technique was performed. Visual acuity improved to 20/80 after closing of macular hole and partial recovery of outer retinal layers at 3 months from the last surgery.

Intravitreal Dexamethasone Implant for Postoperative Macular Oedema Secondary to Vitrectomy for Epiretinal Membrane and Retinal Detachment: A Systematic Review and Meta-Analysis.

PURPOSE: To evaluate the efficacy of intravitreal dexamethasone implant (DEX) for the treatment of macular oedema secondary to vitrectomy for epiretinal membrane (ERM) and retinal detachment (RD) by conducting a systematic review with meta-analysis of published studies. METHODS: Studies reporting clinical outcomes of DEX use for the treatment of macular oedema secondary to ERM and RD vitrectomy were searched on PubMed and Embase databases. The primary outcome was best-corrected visual acuity (BCVA) change between baseline and post-DEX treatment, reported as mean difference (MD) with 95% confidence interval (CI). Mean central macular thickness (CMT) change was assessed as a secondary outcome. Postimplant adverse events, including intraocular pressure rise and cataract development, were reported as well. RESULTS: Five uncontrolled studies, 1 nonrandomized controlled study, and 1 randomized controlled study were included, with a total of 5 cohorts and 3 cohorts in the ERM group and RD group, respectively. Considering the last available follow-up, a significant improvement in postimplant BCVA was found in the overall population, irrespective of the indication for vitrectomy (MD = -0.28, 95% CI = -0.37, -0.20; p < 0.001), but with significant heterogeneity. In either group, mean BCVA significantly improved following the implant (in the ERM group, MD = -0.31, 95% CI = -0.40, -0.22; in the RD group, MD = -0.22, 95% CI = -0.41, -0.03), with no difference between the two groups (p=0.41). However, there was significant heterogeneity in both groups. Considering the last available follow-up, a significant CMT reduction was found in the overall population, irrespective of the indication for vitrectomy (MD = -129.75, 95% CI = -157.49, -102.01; p < 0.001). In the ERM group, a significant CMT reduction was shown following DEX (MD = -133.41, 95% CI = -155.37, -111.45; p < 0.001), with no heterogeneity. In the RD group, mean CMT reduction was borderline significant (MD = -128.37, 95% CI = -253.57, -3.18; p=0.040), with significant heterogeneity. No difference in CMT improvement was found between the two groups (p=0.94). CONCLUSION: This meta-analysis showed that DEX yielded a significant improvement in visual and anatomical outcomes, even if limited by significant heterogeneity. Dexamethasone implant represents an effective treatment for postoperative macular oedema secondary to ERM and RD vitrectomy.

Intravitreal Therapy for Diabetic Macular Edema: An Update.

Diabetic macular edema (DME) represents a prevalent and disabling eye condition. Despite that DME represents a sight-threatening condition, it is also among the most accessible to treatment. Many different treatment options including photocoagulation, intravitreal medical treatment (either vascular endothelial growth factor inhibitors or corticosteroids therapies), and surgical removal are currently available. Although laser has been considered as the gold standard for many years, over the past several years vascular endothelial growth factor inhibitors (anti-VEGFs) have become first-line therapy. However, many patients do not adequately respond to them. With the development of sustained-release corticosteroid devices, steroids have gained a presence in the management of the DME. We review and update the role of anti-VEGF and intravitreal sustained-release corticosteroid management of DME. According to the currently available scientific evidence, the choice of one anti-VEGF over another critically depends on the baseline best-corrected visual acuity (BCVA). While aflibercept may be the drug of choice in low baseline BCVA, the three anti-VEGFs (bevacizumab, ranibizumab, and aflibercept) provided similar functional outcomes when the baseline BCVA was higher. DEX implants are a valuable option for treating DME, although they are usually seen as a second choice, particularly in those eyes that have an insufficient response to anti-VEGF. The new evidence suggested that, in eyes that did not adequately respond to anti-VEGF, switching to a DEX implant at the time to 3 monthly anti-VEGF injections provided better functional outcomes.

Primary vitrectomy for degenerative and tractional lamellar macular holes: A systematic review and meta-analysis.

PURPOSE: To assess the efficacy of vitrectomy in degenerative and tractional lamellar macular holes (LMHs) by meta-analysis of published studies. METHODS: PubMed, Medline and Embase databases were searched up to May 2020. Included cohorts were divided into three groups: degenerative LMH group, lamellar hole associated epiretinal proliferation (LHEP) group and tractional LMH group. LHEP is likely to be associated with degenerative LMHs, but less commonly could be associated with mixed LMHs. To reduce risk of possible misclassification bias, eyes with LHEP which could not have been precisely classified by the authors, were included into the LHEP group. The primary outcome was to investigate the visual change following primary vitrectomy in the degenerative LMH and LHEP group versus the tractional LMH group. A sensitivity analysis excluding the LHEP group was also performed on the primary outcome. Mean difference (MD) in best corrected visual acuity between baseline and post-treatment was calculated, along with 95% confidence interval (CI). Rate of incidence of post-operative full-thickness macular hole (FTMH) was assessed as secondary outcome. RESULTS: Thirteen studies were included. Pooled analyses including all groups showed a significant visual improvement following vitrectomy (pre-post MD = -0.17;95%CI = -0.22,-0.12;p<0.001), with no difference in visual improvement between the degenerative LMH and LHEP group and the tractional LMH group. The sensitivity analysis excluding LHEP group confirmed no difference in visual change between the degenerative LMH group (pre-post MD = -0.18;95%CI = -0.24,-0.12;p<0.001) and the tractional LMH group (MD = -0.16;95%CI = -0.26,-0.07;p<0.001). The incidence rate of post-operative FTMH was higher in the degenerative LMH and LHEP group than in the tractional LMH group (p = 0.002). CONCLUSION: Primary vitrectomy for LMH ensured a favorable visual outcome, with no difference in visual gain between degenerative and tractional LMHs. However, a higher incidence of post-operative FTMHs was found in eyes with the degenerative LMH subtype.

Fluocinolone acetonide vitreous insert for chronic diabetic macular oedema: a systematic review with meta-analysis of real-world experience.

We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing these findings with the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study. The primary outcome was mean change of best corrected visual acuity (BCVA) at 24 months. Secondary outcomes were 36-month mean BCVA, mean central macular thickness (CMT) change, rates of eyes receiving supplementary intravitreal therapy, cataract surgery, intraocular pressure (IOP)-lowering drops and glaucoma surgery. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Nine real-world studies were included. The FAc implant yielded a significantly improved BCVA at 24 and 36 months (24-month MD = 4.52; 95% CI 2.56-6.48; 36-month MD = 8.10; 95% CI 6.34-9.86). These findings were comparable with the FAME study. The FAc implant yielded significantly reduced 24- and 36-month CMT. Pooled proportions of cataract surgery, IOP-lowering drops and glaucoma surgery were 39%, 27% and 3%, respectively, all lower than the FAME study. Pooled estimate of supplementary intravitreal therapy was 39%, higher than the 15.2% of the FAME study. This meta-analysis of real-world studies confirms favorable visual and anatomical outcomes following FAc insert for chronic DMO. In real-life studies more than one third of patients received supplementary intravitreal therapy, an issue that needs to be further explored.

Intravitreal anti-vascular endothelial growth factors, panretinal photocoagulation and combined treatment for proliferative diabetic retinopathy: a systematic review and network meta-analysis.

PURPOSE: To conduct a systematic review with network meta-analysis (NMA) of randomized clinical trials (RCTs) comparing panretinal photocoagulation (PRP) versus anti-vascular endothelial growth factor (VEGF) treatment alone or in combination with PRP, for proliferative diabetic retinopathy (PDR). METHODS: PubMed, Medline and Embase databases were searched for RCTs comparing PRP versus intravitreal anti-VEGF therapy and/or combined PRP and intravitreal anti-VEGF for PDR. The primary outcome measures were the mean best corrected visual acuity (BCVA) change and the regression of neovascularization. Mean change of central macular thickness (CMT), the subgroup analyses of patients without diabetic macular oedema (DME) and the rate of vitreous haemorrhage and vitrectomy were secondary outcomes. Frequentist NMAs were performed. RESULTS: Twelve RCTs were included. For the 12-month mean BCVA change, NMA showed a better visual outcome in both the anti-VEGF group and combined group compared to PRP [anti-VEGF vs PRP, mean difference (MD) = 3.42; standard error (SE) = 1.5; combined vs PRP, MD = 3.92; SE = 1.65], with no difference between combined group and anti-VEGF (MD = -0.50; SE = 1.87). No difference in neovascularization regression was found between PRP and anti-VEGF alone or in combination with PRP, but there was significant inconsistency (p = 0.016). Subgroup analyses in patients without DME yielded no difference for the 12-month visual outcome between the three interventions, but with significant inconsistency (p = 0.005). CONCLUSION: This NMA showed limited evidence of comparable efficacy in terms of neovascularization regression between PRP and anti-VEGF therapy alone or in combination with PRP, but better visual outcomes were associated with anti-VEGF use. Intravitreal anti-VEGF therapy could be a valid therapeutic option in association with PRP.

Treat and extend versus fixed regimen in neovascular age related macular degeneration: A systematic review and meta-analysis.

PURPOSE: To compare efficacy of treat and extend (T&E) versus fixed regimen treatment protocols in neovascular age-related macular degeneration (nAMD). METHODS: Randomized clinical trials (RCTs) comparing T&E versus fixed regimen protocols for nAMD were systematically searched. Primary outcome was to compare the mean best corrected visual acuity (BCVA) change in T&E regimen versus fixed regimen. Secondary outcomes were change in the mean optical coherence tomography (OCT) central retinal thickness (CRT) and mean number of injections. Standardized mean difference (SMD) along with 95% confidence intervals (CIs) were calculated. Random-effect models were used for meta-analyses. RESULTS: Four RCTs were included, with a total of 649 and 621 eyes in the T&E and fixed regimen cohort at 12 months, and 267 and 249 eyes at 24 months. Pooled analysis of mean BCVA change included all four RCTs at 12 months and two RCTs at 24 months, showing no difference between the two groups (12-month: SMD = 0.08, 95% CI: -0.20 to 0.35, p = 0.55; 24-month: SMD = 0.04, 95% CI: -0.13 to 0.21, p = 0.64). Pooled analysis of OCT CRT change at 12 months included three studies, showing no difference between the two groups (SMD = 0.03, 95% CI: -0.46 to 0.51, p = 0.91). Pooled analysis of mean injection number included all four RCTs at 12 months and two RCTs at 24 months, showing significant difference between the two groups (12-month: SMD = -1.11, 95% CI: -1.67 to -0.56, p < 0.001; 24-month: SMD = -1.34, 95% CI: -1.54 to -1.15, p < 0.001). CONCLUSION: A T&E regimen proved as effective as a fixed dosage regimen throughout a 24-month follow-up and with a lower number of injections.

DIABETIC MACULAR EDEMA AND CATARACT SURGERY: Phacoemulsification Combined With Dexamethasone Intravitreal Implant Compared With Standard Phacoemulsification.

PURPOSE: To compare functional and anatomical results of combined phacoemulsification and dexamethasone intravitreal implant (Ozurdex; DEX-I) with standard phacoemulsification in diabetic patients with cataract. METHODS: Retrospective, comparative, cohort study. Patients with nonproliferative diabetic retinopathy, macular edema, and cataract, treated routinely at the Eye Clinic, Azienda Ospedaliero Universitaria Policlinico, Bari, Italy with phacoemulsification associated with DEX-I (n = 23; Phaco-Dex) or standard phacoemulsification (n = 23; Phaco-alone). Best-correct visual acuity, central subfield thickness, and intraocular pressure were assessed at baseline and monthly for 3 months after surgery, and t-test was used to assess change from baseline. A multilevel regression model with an unstructured correlation-type matrix to account for repeated data measures was used for statistical analysis in and between groups. RESULTS: With Phaco-Dex, best-correct visual acuity increased significantly from the first month (P = 0.0005 vs. baseline) and remained stable at the following visits; central subfield thickness decreased significantly from Month 2 (P = 0.049 and P = 0.04 vs. baseline, respectively); at each timepoint, central subfield thickness was significantly lower in the Phaco-Dex group versus Phaco-alone. Intraocular pressure increased significantly during follow-up (P = 0.001 at Month 3 vs. baseline) but remained within the normal range. In the Phaco-alone group, best-correct visual acuity, and intraocular pressure did not show any significant changes after surgery, whereas central subfield thickness increased from Month 2 (P = 0.05 vs. baseline). CONCLUSION: In diabetic patients with macular edema and visually significant cataract, combined treatment with phacoemulsification and DEX-I seemed to be effective, safe, and superior to standard phacoemulsification considering both functional and tomographic parameters.

Intravitreal dexamethasone implant one month before versus concomitant with cataract surgery in patients with diabetic macular oedema: the dexcat study.

PURPOSE: To report clinical outcomes of two different timings of intravitreal dexamethasone (DEX) implant administration for prevention of diabetic macular oedema (DME) worsening following cataract surgery. METHODS: This multicentre, retrospective study included patients with DME who received an intravitreal DEX implant 1 month before cataract surgery, 'precataract DEX' group, or at the time of cataract surgery, 'concomitant treatments' group. Inclusion criteria were a follow-up ≥3 months and ophthalmological examination with optical coherence tomography (OCT) imaging at baseline (cataract surgery) and throughout follow-up. Anatomical improvement was considered to be a decrease in OCT central subfield (CSF) thickness ≥20% compared to baseline. The primary outcomes were anatomical and functional results at 3 months. RESULTS: Two hundred twenty-one patients were included: 136 in the 'precataract DEX' group and 85 in the 'concomitant treatments' group. At 3 months, a reduction of CSF thickness ≥ 20% was found in 7.3% of eyes in the 'precataract DEX group' and in 83.7% of eyes in the 'concomitant treatments' group (p < 0.001), with mean CSF thickness lower in the latter group (371 ± 52 µm versus 325 ± 57 µm, p < 0.001). At 3 months, mean best-corrected visual acuity had improved from baseline in both groups (p < 0.001), with no difference between groups (p = 0. 20). No serious systemic adverse events were reported. CONCLUSION: Both approaches prevented a worsening of DME, showing a comparable visual outcome. Dexamethasone (DEX) implant given at the same time as cataract surgery provided a better anatomical outcome.

Efficacy of Intravitreal Dexamethasone Implant in Different Patterns of Diabetic Macular Edema.

PURPOSE: Different patterns of diabetic macular edema (DME) suggest different pathogenesis and drug response. We evaluated the outcomes after intravitreal dexamethasone (DEX) implant for DME with or without serous retinal detachment (SRD). METHODS: In this retrospective study, 22 naïve patients (23 eyes) with DME who underwent a single DEX implant were evaluated. Based on the optical coherence tomographic pattern of DME, 12 eyes had a cystoid macular edema pattern (Group 1) and 11 eyes had an SRD pattern (Group 2). The best-corrected visual acuity (BCVA), central retinal thickness (СRТ), central retinal volume (CRV), SRD height (SRDh), and intraocular pressure (IOP) were recorded before and at two and four months after the treatment. RESULTS: There were no significant differences between the groups regarding demographic, clinical data and outcomes at baseline. In Group 1, the CRT and CRV significantly decreased at two months (P = 0.002 and P = 0.01, respectively), while the BCVA significantly improved at four months (P = 0.03). In Group 2, the CRT and CRV significantly improved (P < 0.01 and P ≤ 0.01, respectively) during the follow-up period. At four months, both groups showed a recurrence of DME, Group 1 in particular (two-month CRT reduction, -149 ± 127 µm vs four-month CRT reduction, -72 ± 174 µm; P = 0.04). The mean reduction in CRV was significantly different at four months (Group 1, -0.49 ± 1.7 mm 3 vs Group 2, -1.3 ± 1.3 mm 3 ; P = 0.04). In Group 2, the SRDh significantly decreased at two (P = 0.01) and four months (P = 0.01). Four cases with elevated IOP were managed. CONCLUSION: DEX implants were found to be effective in different patterns of DME. The SRD pattern may predict a longer-lasting morphologic efficacy.