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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. 

Purpose To compare the efficac and safety of a dual-blade 20,000 cuts per minute (cpm) vitrectomy probe with a single-blade 10,000 cpm probe for primary rhegmatogenous retinal detachment (RRD). Study design Prospective, randomized controlled clinical trial. Methods Evaluations were conducted preoperatively, intraoperatively, and at three months postoperatively. The main outcome measure focused on the duration of core vitrectomy, with secondary outcomes including peripheral vitreous shaving duration, balanced salt solution (BSS) consumption, anatomical and functional outcomes, as well as the incidence of surgical procedure-related complications. Results Overall, 35 cases in the 20,000 cpm group and 37 cases in the 10,000 cpm group completed the trial without significant differences in baseline demographic characteristics. The 20,000 cpm group demonstrated significantly shorter core vitrectomy duration (161.6 ± 10.4 vs. 206.8 ± 10.1 s) ( P  = 0.003) and peripheral vitreous shaving time (446.3 ± 20.3 vs. 544.2 ± 22.2 s) ( P  = 0.002) compared to the 10,000 cpm group. BSS consumption was higher in the 20,000 cpm group but without statistical significance ( P  = 0.231). There were no significant differences in the need for scleral sutures and the incidence of iatrogenic retinal breaks ( P  = 0.331 and 0.523). At the 3-month follow-up, there were no statistically significant differences in primary success, final anatomical success, or mean visual acuity ( P  > 0.9, P  = 0.326). Rates of complications, including ocular hypertension, epiretinal membrane formation, and endophthalmitis also showed no statistically significant differences ( P  > 0.6). Conclusion The utilization of the new-generation 27-gauge system with a 20,000 cpm probe may herald a new paradigm of high-flow, smaller-diameter instrumentation, thereby enhancing the efficiency of the small gauge technique.

Aim: To compare 25-gauge vs 20-gauge system for pars plana vitrectomy in a prospective, randomised, controlled clinical trial. Methods: Three-port pars plana vitrectomy was performed in 60 patients belonging to 2 groups. Evaluations were performed preoperatively, intraoperatively, during the first three postoperative days, at 1 week, and at 1 and 3 months. The main outcome measure was time for surgery, divided into duration of wound opening, vitrectomy, retinal manipulation and wound closure. Results: The total duration of surgery showed no significant difference between the groups (p = 0.67). The 25-gauge group showed significantly shorter duration of wound opening (p<0.001) and wound closure (p<0.001). In contrast, the vitrectomy duration was significantly longer in the 25-gauge group (p<0.001). Conjunctival injection and subjective postoperative pain showed significantly lower irritation in the 25-gauge group (p<0.001 for both). Conclusion: The 25-gauge vitrectomy system offered significantly improved patient comfort during the first postoperative week. The smaller surgical openings facilitated wound healing and minimised pain. Duration of surgery was comparable between the two systems—the shorter time needed for wound opening and closure in the 25-gauge group being equalised by the longer vitrectomy duration. Intraoperative as well as retinal manipulation and illumination caused more surgical difficulties using the 25-gauge system.

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.

AimMain failure of diabetic tractional retinal detachment (TRD) surgery is the development of proliferative vitreoretinopathy (PVR), causing higher re-detachment rates. We investigated whether the use of dexamethasone (DEX) implant at the end of pars plana vitrectomy (PPV) with silicone oil tamponade might have an impact on these outcomes.DesignComparative, nonrandomized, retrospective study.ParticipantsA total of 148 eyes from 148 patients that underwent PPV with silicone oil tamponade for diabetic TRD (with DEX implant, n = 52; without DEX implant, n = 96).MethodsConsecutive patients’ records were reviewed for time between TRD diagnosis and surgery; lens status before surgery and after 6, 12, and 24 months; retina attachment rate after primary PPV; change in postoperative PVR severity; rate of re-detachment at 6, 12, and 24 months; use of IOP lowering treatment after 6, 12, and 24 months; surgery details; intra- and postoperative complications. Correlations between outcome measures, postoperative PVR severity, and re-detachment rates were analyzed.Main outcome measuresChange in postoperative PVR severity and retinal re-detachment rates with and without the adjuvant use of DEX implant.ResultsRetinal re-detachment rates were significantly higher in the group of patients that did not receive DEX implant [11/96 (11.5%) vs. 0/52 (0%), p = 0.049; 11/84 (12.9%) vs. 4/52 (7.7%), p = 0.007; 14/71 (19.7%) vs. 5/52 (10%) p < 0.001 at 6, 12, and 24 months, respectively]. PVR severity correlated with retinal status at 12 and 24 months (p = 0.018 and p = 0.027, respectively). The difference in PVR severity between the two groups was statistically significant at 6, 12, and 24 months (p < 0.001).ConclusionsDEX implant at the end of PPV in patients with diabetic TRD improves PVR severity and decreases re-detachment rates. This should be considered as an option in the customized treatment of TRD.

PurposeTo describe functional and histopathological findings after macular peeling using different dyes.MethodsProspective, randomized, comparative, interventional, and immunohistochemical study. Forty-five eyes from 45 patients with idiopathic epiretinal membrane (ERM) underwent pars plana chromovitrectomy with ERM and inner limiting membrane (ILM) using trypan blue 0.15% + brilliant blue 0.05% + lutein 2% in group 1 (15 eyes), trypan blue 0.15% + brilliant blue 0.025% + polyethylene glycol 3350 4% in group 2 (15 eyes), and indocyanine green 0.05% in group 3 (15 eyes). We evaluated visual acuity (VA) and macular sensitivity (MS) preoperatively, 1, 3, and 6 months after surgery. The expression of glial fibrillary acidic protein (GFAP) and neurofilament protein (NF) was assessed immunohistochemically on the ILMs peeled as markers of glial and neuronal cells.ResultsIn group 1, both mean VA and MS were significantly better at 1 and 3 months after surgery (P < 0.05), whereas no significant difference was found after 6 months. GFAP and NF expression was significantly lower in group 1 (P < 0.05).ConclusionsThe ERM/ILM peeling is thought to rip off the intraretinal tissue, based on the amounts of GFAP and NF in the specimens. The use of lutein dyes reduces iatrogenic stress to the retinal tissue and allows a faster functional recovery in the first 3 months after surgery, suggesting a less iatrogenic adhesion to the retinal tissue.

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 To compare the effects of a 3D head-up system and microscope eyepiece-assisted simulated vitrectomy intraocular illumination on the ocular surface of an operator. Methods This was a prospective randomized controlled study. According to the application system, thirty ophthalmic operators (60 eyes) were randomly divided into 3D and eyepiece groups. Under different intensities of intraocular illumination, operators in both groups viewed the fundus model through a 3D display screen or microscopic eyepiece for 2 h. Objective examinations and a subjective symptom questionnaire were used immediately after the test to evaluate the ocular surface of the operators. Objective examinations included nonintrusion tear meniscus height (NIKTMH), nonintrusion break-up time (NIKBUT), and bulbar redness and strip meniscometry tube (SMTube) measurements. Statistical analyses were performed by using SPSS 26.0 software. Results After the test, the NIKTMH, NIKBUT and SMTube measurements decreased; however, the degree of change varied among the groups of different systems. The differences between the 3D group and the eyepiece group in NIKTMH measurements, SMTube measurements, subjective symptom scores (eye dryness, difficulty focusing, and cervical pain), and light intensity reaching the ocular surface of the operators were statistically significant ( P  < 0.05). All of the objective and subjective tests showed that the 3D group had fewer effects on the NIKTMH and SMTube measurements, and the subjective comfort of the 3D group was greater. Conclusion For both 3D screens and eyepieces, simulated vitrectomy with intraocular illumination for two hours can lead to discomfort and abnormalities in the operator’s ocular surface; however, these abnormalities are less severe in the 3D group. Trial registration This trial was registered on December 22, 2022, at the Chinese Clinical Trials Registry with NO. ChiCTR2200066989.

We performed a meta‐analysis to evaluate the effect of 27‐gauge microincision vitrectomy surgery compared with 25‐gauge microincision vitrectomy surgery on wound closure and the need for wound suture and other postoperative parameters in the treatment of vitreoretinal disease. A systematic literature search up to June 2022 was performed and 1264 subjects with the vitreoretinal disease at the baseline of the studies; 562 of them were using the 27‐gauge microincision vitrectomy surgery, and 722 were using 25‐gauge microincision vitrectomy surgery. Odds ratio (OR), and mean difference (MD) with 95% confidence intervals (CIs) were calculated to assess the effect of 27‐gauge microincision vitrectomy surgery compared with 25‐gauge microincision vitrectomy surgery on wound closure and the need for wound suture and other postoperative parameters in the treatment of vitreoretinal disease using the dichotomous, and contentious methods with a random or fixed‐effect model. The 27‐gauge microincision vitrectomy surgery subjects had a significantly lower intraoperative and postoperative wound complication (OR, 6.66; 95% CI, 0.46‐0.95, P = .02), and wound suture number (OR, 0.38; 95% CI, 0.20‐0.71, P = .002), and best corrected visual acuity (MD, −0.03; 95% CI, −0.05 to −0.001, P = .02) compared with 25‐gauge microincision vitrectomy surgery in subjects with vitreoretinal disease. However, 27‐gauge microincision vitrectomy surgery subjects had no significant difference in the wound closure time (MD, −8.45; 95% CI, −23.44 to 6.55, P = .27), operation time (MD, 0.85; 95% CI, −1.17 to 2.86, P = .41), intraocular pressure at postoperative day 1 (MD, 0.42; 95% CI, −1.45‐2.28, P = .66), primary anatomical success rate (OR, 0.83; 95% CI, 0.42‐1.63, P = .58), and central macular thickness (MD, 1.81; 95% CI, −21.76 to 25.37, P = .88) compared to 25‐gauge microincision vitrectomy surgery in subjects with vitreoretinal disease. The 27‐gauge microincision vitrectomy surgery subjects had a significantly lower intraoperative and postoperative wound complication, wound suture number, and best corrected visual acuity, and no significant difference in the wound closure time, operation time, intraocular pressure at postoperative day 1, primary anatomical success rate, and central macular thickness compared to 25‐gauge microincision vitrectomy surgery in subjects with vitreoretinal disease. The analysis of outcomes should be with caution because of the low sample size of 12 out of 15 studies in the meta‐analysis and a low number of studies in certain comparisons.

Aim:To compare the sutureless 23-gauge system with a standard 20-gauge system in pars plana vitrectomy.Methods:60 patients in two randomised groups were included in this prospective clinical trial. Pars plana vitrectomy with either 23- or 20-gauge instruments was performed. The main outcome measures were postoperative conjunctival injection and pain. Secondary outcome parameters were time of surgery, intraocular pressure, visual acuity and complications.Results:Conjunctival injection (p = 0.0003) and postoperative pain (p = 0.01) were significantly reduced following 23-gauge vitrectomy compared with the 20-gauge procedure. Opening (p = 0.006) and closure times (p<0.00001) were significantly shorter, and vitrectomy time (p = 0.001) significantly longer in the 23-gauge system compared with 20-gauge vitrectomy. However, retinal manipulation and overall surgery times did not differ significantly between both groups. The same applies for eye pressure, distance and reading acuity. Regarding complications, two choroidal haemorrhages and one flat serous choroidal detachment occurred in the 23-gauge group.Conclusion:The 23-gauge system for pars plana vitrectomy offers significantly higher patient comfort during the early postoperative period. Time of surgery is almost equal—a shorter time for wound closure is neutralised by a longer vitrectomy time in the 23-gauge group.