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Proliferative diabetic retinopathy is the most common cause of severe sight impairment in people with diabetes. Proliferative diabetic retinopathy has been managed by panretinal laser photocoagulation (PRP) for the past 40 years. We report the 1 year safety and efficacy of intravitreal aflibercept. In this phase 2b, single-blind, non-inferiority trial (CLARITY), adults (aged ≥18 years) with type 1 or 2 diabetes and previously untreated or post-laser treated active proliferative diabetic retinopathy were recruited from 22 UK ophthalmic centres. Patients were randomly assigned (1:1) to repeated intravitreal aflibercept (2 mg/0·05 mL at baseline, 4 weeks, and 8 weeks, and from week 12 patients were reviewed every 4 weeks and aflibercept injections were given as needed) or PRP standard care (single spot or mutlispot laser at baseline, fractionated fortnightly thereafter, and from week 12 patients were assessed every 8 weeks and treated with PRP as needed) for 52 weeks. Randomisation was by minimisation with a web-based computer generated system. Primary outcome assessors were masked optometrists. The treating ophthalmologists and participants were not masked. The primary outcome was defined as a change in best-corrected visual acuity at 52 weeks with a linear mixed-effect model that estimated adjusted treatment effects at both 12 weeks and 52 weeks, having excluded fluctuations in best corrected visual acuity owing to vitreous haemorrhage. This modified intention-to-treat analysis was reapplied to the per protocol participants. The non-inferiority margin was prespecified as −5 Early Treatment Diabetic Retinopathy Study letters. Safety was assessed in all participants. This trial is registered with ISRCTN registry, number 32207582. We recruited 232 participants (116 per group) between Aug 22, 2014 and Nov 30, 2015. 221 participants (112 in aflibercept group, 109 in PRP group) contributed to the modified intention-to-treat model, and 210 participants (104 in aflibercept group and 106 in PRP group) within per protocol. Aflibercept was non-inferior and superior to PRP in both the modified intention-to-treat population (mean best corrected visual acuity difference 3·9 letters [95% CI 2·3–5·6], p<0·0001) and the per-protocol population (4·0 letters [2·4–5·7], p<0·0001). There were no safety concerns. The 95% CI adjusted difference between groups was more than the prespecified acceptable margin of −5 letters at both 12 weeks and 52 weeks. Patients with proliferative diabetic retinopathy who were treated with intravitreal aflibercept had an improved outcome at 1 year compared with those treated with PRP standard care. The Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health Research partnership.

Despite increasing worldwide use of anti-vascular endothelial growth factor agents for treatment of retinopathy of prematurity (ROP), there are few data on their ocular efficacy, the appropriate drug and dose, the need for retreatment, and the possibility of long-term systemic effects. We evaluated the efficacy and safety of intravitreal ranibizumab compared with laser therapy in treatment of ROP. This randomised, open-label, superiority multicentre, three-arm, parallel group trial was done in 87 neonatal and ophthalmic centres in 26 countries. We screened infants with birthweight less than 1500 g who met criteria for treatment for retinopathy, and randomised patients equally (1:1:1) to receive a single bilateral intravitreal dose of ranibizumab 0·2 mg or ranibizumab 0·1 mg, or laser therapy. Individuals were stratified by disease zone and geographical region using computer interactive response technology. The primary outcome was survival with no active retinopathy, no unfavourable structural outcomes, or need for a different treatment modality at or before 24 weeks (two-sided α=0·05 for superiority of ranibizumab 0·2 mg against laser therapy). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02375971. Between Dec 31, 2015, and June 29, 2017, 225 participants (ranibizumab 0·2 mg n=74, ranibizumab 0·1 mg n=77, laser therapy n=74) were randomly assigned. Seven were withdrawn before treatment (n=1, n=1, n=5, respectively) and 17 did not complete follow-up to 24 weeks, including four deaths in each group. 214 infants were assessed for the primary outcome (n=70, n=76, n=68, respectively). Treatment success occurred in 56 (80%) of 70 infants receiving ranibizumab 0·2 mg compared with 57 (75%) of 76 infants receiving ranibizumab 0·1 mg and 45 (66%) of 68 infants after laser therapy. Using a hierarchical testing strategy, compared with laser therapy the odds ratio (OR) of treatment success following ranibizumab 0·2 mg was 2·19 (95% Cl 0·99–4·82, p=0·051), and following ranibizumab 0·1 mg was 1·57 (95% Cl 0·76–3·26); for ranibizumab 0·2 mg compared with 0·1 mg the OR was 1·35 (95% Cl 0·61–2·98). One infant had an unfavourable structural outcome following ranibizumab 0·2 mg, compared with five following ranibizumab 0·1 mg and seven after laser therapy. Death, serious and non-serious systemic adverse events, and ocular adverse events were evenly distributed between the three groups. In the treatment of ROP, ranibizumab 0·2 mg might be superior to laser therapy, with fewer unfavourable ocular outcomes than laser therapy and with an acceptable 24-week safety profile. Novartis.

Monochorionic twin pregnancies complicated by twin-to-twin transfusion syndrome are typically treated with fetoscopic laser coagulation. Postoperative complications can occur due to residual vascular anastomoses on the placenta. We aimed to assess the efficacy and safety of a novel surgery technique that uses laser coagulation of the entire vascular equator (Solomon technique). We undertook an open-label, international, multicentre, randomised controlled trial at five European tertiary referral centres. Women with twin-to-twin transfusion syndrome were randomly assigned by online randomisation (1:1) with permuted blocks to the Solomon technique or standard laser coagulation. The primary outcome was a composite of incidence of twin anaemia polycythaemia sequence, recurrence of twin-to-twin transfusion syndrome, perinatal mortality, or severe neonatal morbidity. Analyses were by intention to treat, with results expressed as odds ratios (ORs) and 95% CIs. This trial is registered with the Dutch Trial Registry, number NTR1245. Between March 11, 2008, and July 12, 2012, 274 women were randomly assigned to either the Solomon group (n=139) or the standard treatment group (n=135). The primary outcome occurred in 94 (34%) of 274 fetuses in the Solomon group versus 133 (49%) of 270 in the standard treatment group (OR 0·54; 95% CI 0·35–0·82). The Solomon technique was associated with a reduction in twin anaemia polycythaemia sequence (3% vs 16% for the standard treatment; OR 0·16, 95% CI 0·05–0·49) and recurrence of twin-to-twin transfusion syndrome (1% vs 7%; 0·21, 0·04–0·98). Perinatal mortality and severe neonatal morbidity did not differ significantly between the two groups. Outside of the common and well-known complications of twin-to-twin transfusion syndrome and its treatment, no serious adverse events occurred. Fetoscopic laser coagulation of the entire vascular equator reduces postoperative fetal morbidity in severe twin-to-twin transfusion syndrome. We recommend that fetoscopic surgeons consider adopting this strategy for treatment of women with twin-to-twin transfusion syndrome. Netherlands Organization for the Health Research and Development (ZonMw 92003545).

Background Traditional continuous diode laser transscleral cyclophotocoagulation (TCW-TSCPC) has been used for decades to reduce intraocular pressure (IOP) by decreasing aqueous humor (AH) production in patients with glaucoma. Micropulse cyclophotocoagulation (MP-TSCPC) and slow coagulation (SC-TSCPC) are the newest transscleral cyclophotocoagulation (TSCPC) techniques that result in lower inflammation and complication rates compared to the traditional technique. Most publications on TSCPC are case series with a retrospective design with different treatment protocols. The objective of this manuscript is to describe the protocol of a randomized clinical trial (RCT) designed to compare the efficacy and safety of MP-TSCPC and SC-TSCPC in patients with refractory glaucoma followed for 12 months. Methods This is a parallel, double-arm single-center, double-masked, RCT that will include eyes with refractory glaucoma. Patients with corrected visual acuity (BCVA) ≤ 20/60, IOP > 21 mmHg, and age ≥ 18 years will be randomized to cyclophotocoagulation using the SC-TSCPC or MP-TSCPC techniques. Follow-up visits will be 1 day, 7 days, 30 days, 3, 6, and 12 months after the procedure. Complete success will be defined as an IOP between 6 and 20 mmHg and a minimum of 30% IOP reduction from baseline, without hypotensive medications. Qualified success will be defined by the same parameters but allowing the use of medication. All follow-up examinations will include determination of BCVA, IOP measurement, slit lamp biomicroscopy, fundoscopy, and macular optical coherence tomography (OCT). The number of hypotensive medications and the occurrence of complications will also be documented. Discussion Our study was designed to compare the efficacy and safety of the two most used TSCPC techniques. Most published studies are retrospective and compare the two new techniques only with the traditional technique. This is, to our knowledge, the first RCT comparing MP-TSCPC and SC-TSCPC techniques. Trial registration Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-5pckbhj on December 15, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.

To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy during 12-month follow-up. The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method. The performance of Pascal panretinal laser coagulation was evaluated as significantly less painful (visual scale of pain was 3.28 ± 1.9) than the performance of conventional photocoagulation (visual scale of pain was 3.93 ± 1.88) with similar efficiency. Distribution of progression of diabetic retinopathy in individual patients was very similar in both groups under comparison, and was strictly paired in 24 of the 30 patients at the end of 1-year follow-up. Laser photocoagulation of the retina with the use of short impulse durations and patterns in patients with diabetic retinopathy given in one session possesses similar efficiency to that of conventional retinal photocoagulation in multiple sessions. The single session treatment is also better tolerated by patients and in addition to this, it shortens the performance of the whole therapy, which potentially saves considerable funds of all subjects participating in the process of treatment. ClinicalTrials.gov NCT03672656.

The prospective, comparative evaluation of combined navigated laser photocoagulation and intravitreal ranibizumab in the treatment of diabetic macular edema has shown advantage of a combination therapy compared to ranibizumab monotherapy at year 1 with significantly reduced injections. The purpose of this retrospective study was to determine the long-term visual gains and need of injections in a 3 year-follow-up period. Retrospective analysis of patients of the original study in the long-term follow-up from month 12 to 36. BCVA measurements following the original 1 year study were taken using logMAR charts. Injections were provided with standard of care using PRN, based on change in BCVA and CRT using SD-OCT scans. Main outcome measures were change in BCVA and mean number of injections from 12 to 36 months. BCVA was stable in both groups from 12 through 36 months, showing a change of 0.16 ± 0.1 log MAR. Following the initial reduction in required injections at month 12, combination therapy patients continued to require 1.3 times fewer injections over the next 24 months (2.91 ± 2.3 vs 3.85±3.7 injections for monotherapy). Combination of navigated laser and ranibizumab achieved BCVA gains equivalent to anti-VEGF monotherapy. These results could be maintained through month 36. Required injections were 2.0 injections lower in year 1 and further 1.3 times fewer in year 2 and 3 in the combination group compared to monotherapy. Adding navigated laser photocoagulation to intravitreal anti-VEGF therapy may still represent a superior therapeutic approach to DME patients.

Diabetic retinopathy (DR) is the most prevalent microvascular complication of diabetes. Panretinal photocoagulation (PRP) is the established treatment for mitigating severe visual impairment resulting from proliferative DR. This study aims to investigate the impact of PRP on the macular region in patients with DR, utilizing optical coherence tomography (OCT) for assessment. An experimental study was meticulously designed, implementing PRP as the primary intervention. The investigation was conducted within the Department of Ophthalmology at the Affiliated Huaian No.1 People's Hospital, Huai'an, Jiangsu, China. A total of 120 participants diagnosed with DR and undergoing treatment at our hospital were enrolled in the study. The participants were randomly assigned to either the control group (CG, n = 60) or the study group (SG, n = 60). The CG received conventional drug treatment involving oral iodized lecithin, while the SG received PRP. OCT was employed to monitor changes in macular fovea volume and macular retinal thickness. Evaluation criteria encompassed clinical efficacy, macular fovea volume, macular retinal thickness, IL-6 and VEGF levels, incidence of adverse reactions, and quality of life in both groups. The study resulted in a higher total effective rate in the SG (96.67%) compared to the CG (80.00%) (χ2 = 8.09, P < .05). Post-treatment, reductions were observed in macular fovea volume and macular retinal thickness, with significantly lower SG values than CG values (P < .05). Both serum IL-6 and VEGF levels exhibited reductions in both groups after treatment, with the SG displaying a more significant decrease compared to the CG (P < .05). The occurrence of adverse reactions significantly decreased in the SG relative to the CG (P < .05). Quality of life scores for the SG was notably elevated compared to the CG (P < .05). PRP emerges as a highly valuable approach in the management of DR. It contributes to retinal thickness improvement within the macular region and inflammation reduction, and also enhances therapeutic outcomes, minimizes adverse reactions, and optimizes patients' quality of life. These findings warrant further clinical adoption and widespread promotion.

To compare the efficacy and safety of transscleral cyclophotocoagulation (TSCPC) using the pop-titrated (PT-TSCPC) versus the slow-coagulation (SC-TSCPC) energy delivery technique in the treatment of neovascular glaucoma (NVG) patients with dark irises. Randomized clinical trial. Ninety-seven Asian NVG patients. Forty-eight and 49 eyes were randomized to receive PT-TSCPC (1,500-2,500 mW for 2 s) and SC-TSCPC (1,250 mW for 4 s), respectively. Patients were followed up for five years. The success rate, the response rate, the retreatment rate, the cyclodiode efficacy index, the numerical pain rating scale (NPRS), visual acuity (VA), and complications. The preoperative parameters were comparable between both groups. The SC technique required 99.7 ± 35 joules, whereas the PT technique needed 78.3 ± 18.2 joules, P  < 0.001). The PT method caused more eye pain during treatment than the SC method (NPRS; 6 vs. 1.8, P  < 0.001). The mean intraocular pressure (IOP) at the last visit was 18.8 ± 5.3 mm Hg in the PT-TSCPC group ( P  < 0.001; 45% reduction from the baseline level) and 15.5 ± 6.7 mm Hg in the SC-TSCPC group ( P  < 0.001; 56% reduction), P  = 0.02). The success rates were 60.4% in the PT-TSCPC group and 71.4% in the SC-TSCPC group ( P  = 0.14). The response rates were 85.4% and 79.6% for the PT- and SC-TSCPC groups, respectively (P  = 0.46). The cumulative probability of success at 5-year follow-up was 48.6% and 69.3% in the PT- and SC-TSCPC groups, respectively ( P  = 0.03). The SC-TSCPC group required > 1 laser session than the pop-titrated technique (22.4% vs. 6.3%, P  = 0.002). VA was worsening in 54.2% of PT-treated eyes and 51% of SC-treated eyes ( P  = 0.13). Worsening of intraocular inflammation (HR 2.63; 95%CI,1.11–6.26; P  = 0.028), PT technique (HR 2.17; 95% CI,1.01–4.71; P  = 0.048), male gender (HR 2.13; 95% CI,1.01–4.55; P  = 0.048), were the risk factors for TSCPC failure in NVG. The slow-coagulation TSCPC may achieve more efficacious IOP reduction and has better safety profiles than the pop-titrated technique for treating NVG patients with dark irises. Nevertheless, it requires more laser sessions and energy than the power titrating protocol. Trial registration Clinicaltrials.gov Identifier NCT01774227 (23/01/2013).

Aim:The study was a prospective randomised controlled double-masked trial performed in two centres to compare sub-threshold micropulse diode laser photocoagulation (MPDL) with conventional green laser photocoagulation (CGL) in the treatment of clinically significant diabetic macular oedema (CSMO).Methods:Fifty-three patients (84 eyes) with diabetic CSMO were randomly assigned to MPDL (n = 44) or CGL (n = 40) according to the modified Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Treatments were performed after baseline and re-treatments were allowed at or after the 4 month visit if necessary. Parameters noted included the best corrected visual acuity (BCVA), colour fundus photographs, central retinal thickness using optical coherence tomography (OCT), vision contrast sensitivity with Pelli–Robson charts and presence of visible laser scars at baseline and at 4 and 12 months. The primary outcome was BCVA at 12 months.Results:All patients completed 12 months of follow-up after treatment at baseline. There were no statistically significant differences in BCVA, contrast sensitivity and retinal thickness between the two laser modalities at 0, 4 and 12 months. We found that laser scarring was much more apparent with CGL than with the sub-threshold approach (MPDL). Laser scars were identified at the 12 month visits in 13.9% of the MPDL-treated eyes compared with 59.0% of the CGL-treated eyes (p<0.001).Conclusion:Sub-threshold micropulse diode laser photocoagulation is equally as effective as CGL treatment for CSMO.Trial registration number:ISTRN 90646644.

Background/aimsThis work aims to clarify whether micropulse transscleral cyclophotocoagulation (MPCPC) is gentler in terms of postoperative inflammation and is better tolerated compared with continuous wave cyclophotocoagulation (CWCPC).MethodsProspective, randomised controlled, interventional, single-centre trial performed at the Ludwig Maximilians University Munich from January 2020 to July 2023. In all patients, a laser flare meter was used to measure anterior chamber flare (ACF). Central macular thickness (CMT) was assessed using optical coherence tomography. To quantify pain perception and quality of life (QoL), patients completed the Visual Analogue Scale (VAS) and the Glaucoma Activity Limitation 9 questionnaire.Results60 eyes of 60 patients were included, with 30 eyes in the MPCPC group and 30 eyes in the CWCPC group. A significantly higher increase in ACF was found after CWCPC as compared with MPCPC at 1 day (p=0.004) and 1 week after surgery (p=0). ACF values equalised at week 6 (p=0.270) and month 3 (p=0.610). The increase in ACF at week 1 did not show a significant correlation with the final decrease in intraocular pressure (IOP, p=0.465). Moreover, the CWCPC group showed a markedly higher increase in CMT (165.5 (15–354) µm vs 55.8 (24–141) µm). VAS and QoL scores did not show to be significantly different.ConclusionsCompared with MPCPC, patients treated with CWCPC presented with more marked ACF only in the early postoperative period. ACF did not correlate with final IOP. CWCPC and MPCPC are equally well tolerated in terms of pain perception and QoL, but CWCPC may cause more severe inflammatory macular oedema.