Explore the vast range of titles available.

BackgroundAfter idiopathic epiretinal membrane (iERM) removal, it is unclear whether the internal limiting membrane (ILM) should be removed. The objective was to assess if active ILM peeling after iERM removal could induce microscotomas.MethodsThe PEELING study is a national randomised clinical trial. When no spontaneous ILM peeling occurred, patients were randomised either to the ILM peeling or no ILM peeling group. Groups were compared at the month 1 (M1), M6 and M12 visits in terms of microperimetry, best-corrected visual acuity (BCVA) and optical coherence tomography findings. The primary outcome was the difference in microscotoma number between baseline and M6.Results213 patients were included, 101 experienced spontaneous ILM peeling and 100 were randomised to the ILM peeling (n=51) or no ILM peeling group (n=49). The difference in microscotoma number between both groups was significant at M1 (3.9 more microscotomas in ILM peeling group, (0.8;7.0) p=0.0155) but not at M6 (2.1 more microscotomas in ILM peeling group (−0.5;4.7) p=0.1155). Only in the no ILM peeling group, the number of microscotomas significantly decreased and the mean retinal sensitivity significantly improved. The ERM recurred in nine patients in the no ILM peeling group (19.6%) versus zero in the ILM peeling group (p=0.0008): two of them underwent revision surgery. There was no difference in mean BCVA and microperimetry between patients experiencing or not a recurrence at M12.ConclusionSpontaneous ILM peeling is very common. Active ILM peeling prevents anatomical ERM recurrence but may induce retinal impairments and delay visual recovery.Trial Registration NCT02146144.

ObjectivesTo evaluate the use of a three-dimensional heads-up microscope (3DM) during 25-gauge pars plana vitrectomy (PPV) compared with a traditional ophthalmic microscope (TM) in terms of efficacy, safety, and teaching and learning satisfaction.MethodsProspective comparative interventional study. Fifty eyes affected by one of the following diseases: rhegmatogenous or tractional retinal detachment, epiretinal membrane, full-thickness macular hole, vitreous hemorrhage, or dropped lens. The 50 eyes were randomly assigned to one of two groups: group A (25 eyes) underwent 25-gauge PPV with 3DM, and group B (25 eyes) underwent 25-gauge PPV with TM. The main outcome measures were the duration of the operation, intraoperative complications, and surgeon and observer satisfaction. A questionnaire was used to assess surgeon satisfaction according to the following parameters: comfort, visibility, image quality, depth perception, simplicity of use, maneuverability, and teaching. A questionnaire to assess observer satisfaction was completed by 20 observers (surgical residents or ophthalmic surgeons).ResultsThe degree of satisfaction was higher using 3DM for both surgeons and observers (P < 0.001). The average duration of the operation did not differ significantly between the two methods. No major complications occurred for either method.ConclusionsPPV with 3DM is more comfortable for the surgeon and poses no substantially greater risk of complications for the patient. The high-definition screen delivers excellent depth perception and better screen parameter control, which results in high-quality surgical performance. 3DM surgery helps to significantly improve teaching and learning intra-operative surgical procedures.

Purpose To compare the anatomic and functional outcome of two variants of the inverted internal limiting membrane (I-ILM) flap technique for idiopathic macular holes (IMH) larger than 400 µm. Methods Twenty-seven consecutive patients undergoing PPV for IMH were randomly assigned to different variants of I-ILM technique: the Cover group included 14 patients in which the I-ILM was folded upside-down over the MH as a single layer while the Fill group enrolled 13 patients in which the I-ILM was folded within the MH in multiple layers. Results MH closed in 12/14 Cover and in 13/13 Fill eyes (84.6 vs. 100%, p  = 0.14; n.s.). Vision at 1 month was Snellen 0.44 ± 0.17 vs. 0.28 ± 0.21 ( p  = 0.05) and 0.48 ± 0.20 vs. 0.37 ± 0.25 (n.s.) at 3 months. IS/OS line interruption width was 463 ± 385 vs. 602 ± 210 µm, respectively, at 1 month (n.s.) and 602 ± 210 vs. 563 ± 209 µm at 3 months (n.s.). The Cover group showed outer retina cystic changes more often ( p  < 0.01). MH over 700 µm closed in 0/2 and in 2/2 cases, respectively, in the Cover and Fill groups (0.045). Conclusions Cover and Fill I-ILM techniques allowed similar closure rates and post-operative vision at 3 months. The Cover group showed better anatomical restoration and vision at 1 month while the Fill technique might be more efficient in closing larger MHs.

Background and Objective: This pilot study aimed to evaluate the outcomes of a novel large-bore cannula aspiration technology developed in our laboratory in comparison to phacofragmentation for addressing complete lens dislocation. Patients and Methods: Thirty-seven eyes with complete lens dislocation were randomly assigned to two groups. In both groups, standard 3-port pars plana vitrectomy (PPV) was performed to remove the vitreous. The dislocated lens was removed by phacofragmentation or the large-bore cannula aspiration technology, based on the random grouping. The “cannula” aspiration instrument was made of the trocar of a 20-G vein detain needle. After the suction line was twisted off, the “cannula” was connected to the proximal end of the suction line. Nineteen eyes were treated with this novel large-bore cannula aspiration technology and the remaining 18 eyes were operated with phacofragmentation to extract the dislocated lenses. Patients were followed up for ≥ 6 months. Several relevant indicators were compared between the two groups, including intraocular pressure (IOP), the change in IOP from preoperative to postoperative measurements, and the incidence of postoperative complications. Results: There were no significant differences in demographic and baseline characteristics between the two groups. Mean duration of surgery was comparable between the two groups. Three eyes in the phacofragmentation group had scleral burns, whereas no scleral burns were observed in the aspiration group. In terms of IOP, the phacofragmentation group exhibited lower IOP compared to the aspiration group on both the first and second days postsurgery (P < .01). Additionally, during the same postoperative period, the difference in IOP between preoperative and postoperative was significantly smaller in the aspiration group compared to the phacofragmentation group (P < .01). However, IOP levels were comparable between the two groups 1 week after surgery. Conclusion: This pilot study demonstrated that the new large-bore cannula aspiration technology can be effectively used for lens extraction. The large-bore cannula aspiration technology avoids the use of ultrasonic energy, thereby eliminating the direct risk of thermal scleral injury and potential retinal damage from ultrasound shockwaves. Thus, this new large-bore cannula aspiration technology can be further explored for complete lens dislocation surgery.

BackgroundThis open-label extension study to the original VIPER trial investigated the long-term single surgery success after repair of an uncomplicated pseudophakic retinal detachment (PRD) by vitrectomy and gas with or without an encircling band (EB).MethodsExamination data from patients enrolled in the VIPER trial obtained after the 26-weeks’ follow-up period (26-weeks’ FU) of the original trial were analysed, and failures, given as indications for another reattachment procedure, were documented.ResultsFrom the original study population of 257 patients enrolled to the three treatment groups (20G vitrectomy+EB (E1), 20G vitrectomy alone (C) and 23/25G vitrectomy (E2)), follow-up data from 105 (41%) patients could be collected. The additional postoperative follow-up was 1.4 months up to 10.8 years. Of the 105 patients enrolled in this long-term analysis, 102 had an observation time greater than 2 years. Failures due to the reattachment procedure within the 26-week FU of the original trial were as follows: 17 in E1, 19 in C and 5 in E2. Additional late failures were found in seven cases: two in E1, three in C and two in E2, respectively.ConclusionsThe long-term observation of additional failures after primary vitrectomy with or without EB did not change the main result of the VIPER study. There is still no evidence that an additional EB would improve the primary surgical success of vitrectomy for uncomplicated PRD. In the cohort of 105 patients with a longer follow-up than 26 weeks, only seven additional failures were observed.Trial registration numberDKRS00023359.

Background The vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER) trial is a pan-European, two-group, non-commercial, active-control, observer-masked, superiority, randomised controlled surgical clinical trial of an investigational medicinal product. Methods The original protocol for this trial was published on 31 January 2022 ( https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05966-3 ). This update reports on key changes in the study protocol in version 2.0 which was approved for trial sites from 18 January 2022, and the current version 3.0 which was approved for trial sites from 25 April 2023, and includes current versions of the statistical analysis plan and health economics analysis plan. In summary, there have been changes to three eligibility criteria: removing the word “Actilyse” from exclusion criterion 2, updating exclusion criterion 5 to state abstinence from heterosexual intercourse or the use of highly effective methods of birth control is mandatory for up to 12 weeks after last aflibercept exposure on trial, and clarifying exclusion criterion 6 relating to international normalised ratio (INR) is only applicable to participants receiving warfarin. Changes to secondary outcomes include Radner Reading speed being limited to the study eye only, and moving EQ-5D-5L from a secondary reported efficacy outcome to a component of health economic analysis reporting only. Actilyse Cathflo was added as an additional permitted investigational medicinal product as this is already used in practice in the UK and is molecularly identical to Actilyse 10 mg. Instructions were added to account for participants who had already been exposed to aflibercept or a similar anti-vascular endothelial growth factor (anti-VEGF) within 21 days (the minimum window between anti-VEGF treatments permitted on trial) prior to study enrolment, storage of tissue plasminogen activator in theatre and operating room environments, and the recording of additional, as-needed aflibercept treatments in-between study visits at the discretion of the study investigator. Finally, sections and subsections have been added to detail the imaging analysis plan, patient public involvement plan, INR testing, and recruitment and informed consent components of the trial. The primary analysis of the trial as stated in the statistical analysis plan is the difference between groups in the proportion of participants gaining ≥ 10 ETDRS letters in their study eye at the month 12 visit, whilst the primary health economic analysis of the trial is the difference in quality-adjusted life years between groups at 12 months. Trial registration ClinicalTrials.gov identifier: NCT04663750 ; EudraCT: 2020–004917-10. 

AimTo assess the primary reattachment rate (PARR) in pneumatic retinopexy (PnR) versus pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD) meeting the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomised Trial (PIVOT) criteria with a single break in detached retina.MethodsA post hoc analysis of two clinical trials. To be included, patients with primary RRD had to meet PIVOT criteria but could have only one break in the detached retina. Patients with additional pathology in the attached retina were included in a secondary analysis. The primary outcome was PARR following PnR versus PPV at 1-year postoperatively.Results162 patients were included. 53% (86/162) underwent PnR and 47% (76/162) had a PPV. 99% (85/86) and 86.8% (66/76) completed the 1-year follow-up visits in the PnR and PPV groups, respectively. PARR was 88.2% (75/85) in the PnR group and 90.9% (60/66) in the PPV group (p=0.6) with a mean postoperative logMAR best-corrected visual acuity of 0.19±0.25 versus 0.34±0.37 (Snellen 20/30 vs 20/44) (p=0.01) each in the PnR and PPV groups, respectively.In an additional analysis of patients who were also allowed to have any pathology in the attached retina, the PARR was 85% (91/107) and 91.6% (66/72) in the PnR and PPV groups, respectively (p=0.18).ConclusionsPnR and PPV provide similar long-term PARR in a substantial proportion of patients meeting PIVOT criteria with only a single break in the detached retina. Therefore, in patients meeting these specific criteria, PnR is an appropriate first-line therapy as it offers superior functional outcomes without compromising PARR.

Full-thickness macular holes (FTMH) are defects in the fovea involving all neural retinal layers. They reduce patients' visual acuity (VA) and impact their quality of life. FTMHs are repaired with pars plana vitrectomy (PPV) with intraocular gas tamponade and post-operative face-down positioning (FDP). There is no consensus regarding the ideal positioning requirements following FTMH repair and there lacks clear guidelines on the topic. While analysis of global practice patterns indicates that between 5-7 days is the most common duration suggested by surgeons, there is significant heterogeneity in surgeon preferences. There is, however, biological plausibility to support minimal or even no FDP following surgery and given the disabling nature of FDP for patients, there is a need to better assess key patient outcomes with different FDP durations. As such, this prospective randomized controlled pilot trial will compare 3-days of FDP to 7-days of FDP following PPV for FTMH. This single-centered, parallel-group randomized controlled pilot trial will randomize patients 1:1 following PPV to 3 days or 7 days of FDP. This investigation has been approved by the local ethics board (HiREB # 16100) and has been registered on clinicaltrials.gov (NCT06000111). The primary objective will be focused on assessing the feasibility of a larger trial; this will be determined through an assessment of the recruitment rate, retention rate, completion rate and recruitment time. The secondary outcomes involve assessment of the following patient-important outcomes a) macular hole closure rate, b) best-recorded VA, c) a general quality of life measure and vision-specific quality of life measure, d) patient compliance and e) complication rates. Outcomes will be evaluated at 3 months following surgery. The results of this pilot study will determine the feasibility of a larger-scale trial that will answer a patient important question with clinical equipoise.

Purpose The purpose of this study was to compare 27-gauge (27G) with 25-gauge (25G) microincision vitrectomy in patients with epiretinal membrane (ERM). Participants Seventy-four eyes of 66 patients undergoing 3-port pars plana vitrectomy using 27G or 25G instrumentation. Methods Seventy-four eyes of 66 patients with ERM, who underwent 27G or 25G microincision vitrectomy were prospectively evaluated. Results The mean operation time for vitrectomy was significantly longer in the 27G group than in the 25G group (9.9±3.5 vs 6.2±2.7 min, respectively, P <0.0001). No statistically significant difference was found between the two groups in terms of the mean operation time for ERM–inner limiting membrane peeling (27G vs 25G: 20.2±9.9 vs 16.1±9.3 min, P =0.14), although the time for vitreous cutting was longer in the 27G group (9.9±3.5 vs 6.2±2.7 min, respectively, P <0.0001). The flare value, intraocular pressure (IOP), and rate of hypotony 1 day after surgery did not differ between the 27G and 25G groups (flare value: 18.7 vs 17.2; IOP: 8.8 vs 9.7 mm Hg; rate of hypotony: 30 vs 35%, respectively). There was no significant difference in the surgically induced astigmatism between the two groups in the follow-up period. The mean time required for wound closure did not show a significant difference between the 27G and 25G groups (7.7 vs 8.6 weeks, respectively). Conclusion The 27G system is as safe and useful for ERM vitrectomy as the 25G system. Based on its potential, further improvement of 27G instruments could result in greater efficiency.

BackgroundIt is unclear whether or not an additional encircling band improves outcome in vitrectomy for pseudophakic retinal detachment (PRD). Also unclear is whether small gauge transconjunctival trocar-guided vitrectomy is as successful as conventional 20 gauge (G) vitrectomy.Methods257 adult patients with uncomplicated PRD were enrolled in 14 vitreoretinal centres across Germany. Contingent on availability of qualified surgeons, eligible patients were randomly assigned either (i) with ratio 1:1 to 20 G vitrectomy plus encircling band (group E1) or 20 G vitrectomy without any buckle (group C) or (ii) with ratios 1:1:1 to group E1, C or 23/25 G vitrectomy without any buckle (group E2). Treatment success was defined as no indication for any retina reattaching procedure during the follow-up of 6 months.ResultsSuccess was reached in 79.0% (=79/100, group E1) versus 73.5% (=72/98, group C) (p=0.558, OR 1.32, 95% CI 0.65 to 2.65. In group E2 87.7% (=50/57) of patients reached success compared with 78.7% (=48/61) in group C, demonstrating non-inferiority of E2 to C regarding the prespecified margin of 0.8 (OR scale; p=0.05, OR 2.17, 95% CI 0.80 to 5.89). Best corrected visual acuity significantly increased after surgery independent of technique, that is, on average −0.7 (from 1.0 to 0.3) logMAR. Patients suffered from a shift in spherical refraction of −1.0 D in group E1 compared with −0.1 D in group C. Similarly, intraoperative complications (15.2% vs 8.8% of patients) and serious adverse events (30.3% vs 22.5% of patients) were more frequent in group E1.ConclusionsVitrectomy with gas is an efficient and safe treatment for uncomplicated PRD. An additional encircling band does not significantly reduce the risk for any second procedure necessary to reattach the retina in 20 G vitrectomy. Small gauge transconjunctival vitrectomy is not inferior to the conventional 20 G technique.Trial registration numberDKRS 00003158, Results.