Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial.
ABSTRACT: BACKGROUND:Macular hole retinal detachment (MHRD) occurs most commonly in high myopia and causes severe visual impairment and greatly reduces the quality of life. The aim of this study is to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also to compare the treatment efficacy with that of the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method for high myopia-associated MHRD. METHODS/DESIGN:In this clinical trial, 38 patients with MHRD in high myopia will be randomly assigned to two groups (Group 1: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus air-fluid exchange plus silicone oil infusion; Group 2: standard 3-port 23-gauge pars plana vitrectomy plus internal limiting membrane peeling plus inverted internal limiting membrane insertion plus air-fluid exchange). The primary outcome is macular hole closure rate in 3 months after the initial surgery. The secondary outcomes are best corrected visual acuity (BCVA), reattachment rate of retinal detachment, and postoperative complication rate. DISCUSSION:The study results may help to evaluate the efficacy and safety of inverted internal limiting membrane insertion combined with air tamponade in the treatment of MHRD in high myopia, and also compare the efficacy of the new treatment with the conventional "vitrectomy plus internal limiting membrane peeling plus silicone oil tamponade" method. This trial may provide a novel surgical treatment for MHRD in high myopia with more effectiveness and less pain. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03383731 . Registered on 19 December 2017. Retrospectively registered.
Project description:Purpose:To report a new surgical technique with a Finesse Flex loop during internal limiting membrane (ILM) peeling for a case of macular hole retinal detachment (MHRD). Observations:A 55-year-old woman with a history of macular hemorrhage due to high myopia underwent 25-gauge vitrectomy combined with cataract surgery for MHRD. After core vitrectomy, ILM peeling was performed for macular hole (MH) closure with a novel use of a Finesse Flex loop. While holding down the detached retina with the Finesse Flex loop with one hand, ILM peeling was conducted from the temporal to nasal side with the other hand using ILM forceps. Inverted ILM flap technique was combined, and fluid-gas exchange with 12% octafluoropropane tamponade was performed. The MH was closed, and the retina was attached with no postoperative complication. The logMAR best-corrected visual acuity improved post-treatment. Conclusions and Importance:The Finesse Flex loop can be used to control the retina when performing ILM peeling on a detached retina in MHRD patients.
Project description:Myopic foveoschisis (MF) is among the leading causes of visual loss in high myopia. However, it remains controversial whether internal limiting membrane (ILM) peeling or gas tamponade is necessary treatment option for MF.PubMed, EMBASE, CBM, CNKI, WANFANG DATA and VIP databases were systematically reviewed. Outcome indicators were myopic foveoschisis resolution rate, visual acuity improvement and postoperative complications.Nine studies that included 239 eyes were selected. The proportion of resolution of foveoschisis was higher in ILM peeling group than non-ILM peeling group (OR = 2.15, 95% CI: 1.06-4.35; P = 0.03). The proportion of postoperative complications was higher in Tamponade group than non-Tamponade group (OR = 10.81, 95% CI: 1.26-93.02; P = 0.03). However, the proportion of visual acuity improvement (OR = 1.63, 95% CI: 0.56-4.80; P = 0.37) between ILM peeling group and non-ILM peeling group and the proportion of resolution of foveoschisis (OR = 1.80, 95% CI: 0.76-4.28; P = 0.18) between Tamponade group and non-Tamponade group were similar.Vitrectomy with internal limiting membrane peeling could contribute to better resolution of myopic foveoschisis than non-peeling, however it does not significantly influence the proportion of visual acuity improvement and postoperative complications. Vitrectomy with gas tamponade is associated with more complications than non-tamponade and does not significantly influence the proportion of visual acuity improvement and resolution of myopic foveoschisis.
Project description:Background:The aim of this meta-analysis was to compare morphological and functional outcomes between vitrectomy with the inverted internal limiting membrane (ILM) flap technique and vitrectomy with internal limiting membrane peeling in highly myopic eyes with macular hole- (MH-) induced retinal detachment (MHRD). Methods:The PubMed, Web of Science, Embase, and Cochrane Library databases were comprehensively searched from inception to November 10, 2019, for published studies comparing the two techniques for the treatment of MHRD. The outcomes in the collected articles included the postoperative MH closure rate, retinal reattachment rate, and best-corrected visual acuity (BCVA). Review Manager (version 5.3) was used for analyses. Results:In total, seven retrospective studies comparing the inverted ILM flap technique with ILM peeling for the treatment of MHRD were included. The MH closure rate was significantly higher in the inverted ILM flap group than in the ILM peeling group at 6 and 12 months after initial surgery (OR?=?15.39; 95% CI: 6.68 to 35.43;P < 0.00001 and OR?=?12.58, 95% CI: 3.51 to 45.08; P=0.0001), while the retinal reattachment rate was similar in both groups at 6?months after initial surgery (OR?=?2.40; 95% CI: 0.89 to 6.50; P=0.08). Besides, the postoperative BCVA was significantly better in the inverted ILM flap group than in the ILM peeling group at 12 months after initial surgery (MD?=?-0.35; 95% CI: -0.52 to -0.18; P < 0.0001). Conclusions:Thus, the MH closure rate and postoperative BCVA may be better with the inverted ILM flap technique than with ILM peeling for myopic MHRD, while the postoperative retinal reattachment rate appears to be similar with both techniques. Therefore, in the future, vitrectomy with the inverted ILM flap technique should be preferred over standard ILM peeling technique for the treatment of MHRD in highly myopic eyes.
Project description:RATIONALE:Managing retinal detachment due to posterior retinal holes is problematic since standard laser retinopexy or scleral buckling may be difficult to apply and may have brought serious complication. Another surgical method in treating posterior hole related retinal detachment is desired. PATIENT CONCERNS:Three high myopia patients with previous vitrectomy and membrane peeling history suffered from blurred vision and retinal detachment due to posterior pole retinal holes was diagnosed. DIAGNOSES:Patient diagnosed retinal detachment due to posterior retinal holes either as paracentral retinal breaks or macular hole from both indirect ophthalmoscope exam and fundus photography INTERVENTIONS:: The patient underwent lens capsular flap insertion into all the retinal holes, along with gas tamponade or silicone oil tamponade. No laser retinopexy was performed around the retinal holes. OUTCOMES:Of 3 included patients, 1 patient had insertion of the lens capsular flap, an incomplete air-fluid exchange, and 24% sulfur hexafluoride gas tamponade. The other 2 patients, after lens capsular flap insertion, had air-fluid exchange and subretinal fluid drainage with extrusion via soft needle through superior drainage retinotomy and silicon oil tamponade. The retinal holes of all eyes were sealed with retina attached postoperatively. LESSONS:Lens capsular flap is effective in sealing posterior retinal holes and treating the associated retinal detachment without the complication resulting from laser retinopexy, especially in eyes without sufficient internal limiting membrane (ILM) tissue due to previous ILM peeling.
Project description:OBJECTIVE:To compare the efficacy and safety of macular buckling and vitrectomy for myopic traction maculopathy showing macular schisis (MS) and associated macular detachment (MD) but without full-thickness macular hole (FTMH). DESIGN:Prospective, randomized, parallel, open-label study. METHODS:Patients were randomly assigned to either buckling or vitrectomy group. Macular buckling and intravitreal C3F8 gas injection were performed in the buckling group. Small gauge vitrectomy, internal limiting membrane peeling (ILMP) and C3F8 gas tamponade were performed in the vitrectomy group. The patients were followed for 12 months. MAIN OUTCOME MEASURES:Best-corrected visual acuity (BCVA) at 12 months. RESULTS:A total of 85 patients were randomized, 80 eyes were included (41 receiving buckling, 39 received vitrectomy), and 78 patients completed the study. There were less eyes determined as surgical failure and required a second surgery in the buckling group than vitrectomy the group (2.4% versus 18.4%, p = 0.021). After surgery, macular buckling achieved more improvement in BCVA (+21.7 versus +4.5 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, p = 0.002). FTMH development was observed in only 1 (2.4%) eye, after removing of the implant due to recurrent conjunctival erosion, in the buckling group and 10 (26.3%) eyes (seven with-, three without MD) in the vitrectomy group (p < 0.001). More eyes developed cataracts in the vitrectomy group than did in the buckling group (28.9% versus 7.5%, p = 0.014). Macular buckling-associated strabismus (esotropia), binocular diplopia and implant exposure were observed in limited cases. CONCLUSIONS AND RELEVANCE:Macular buckling is superior to vitrectomy with ILM peeling plus gas injection for surgical treatment of MS and associated MD in high myopia.
Project description:To report a complication of retained silicone tip from a diamond-dusted membrane scraper (DDMS) that occurred while using a valved cannula vitrectomy system.Retrospective review of three cases that underwent 23 gauge (G) sutureless vitrectomy for idiopathic macular hole (cases 1 and 2) and myopic macular schisis (case 3).In all three cases following a standard vitrectomy, the internal limiting membrane (ILM) peeling was initiated by using a 23G DDMS. During the insertion of the DDMS, the flexible silicone tip of the 23G DDMS was detached from the metal shaft and was retained in the 23G valve system and in case 3, the silicone tip got dislodged from the valve onto the retina. Subsequent ILM peeling was completed by using an end-gripping forceps. All underwent intravitreal gas injection at the end. No other complications were noted.These three cases demonstrate an uncommon complication of retained silicone tip within the valved cannula vitrectomy system and this complication should be considered while using flexible instruments in valved cannula systems.
Project description:PURPOSE:To evaluate the effect of vitrectomy with inverted internal limiting membrane (ILM) flap for the treatment of macular hole retinal detachment (MHRD) in high myopia compared with that of ILM peeling. METHODS:PubMed, EMBASE, Web of Science, MEDLINE, Ovid, Wan Fang and CNKI were systematically reviewed. The primary outcome parameters were the MH closure rate, retinal reattachment rate and postoperative BCVA. Secondary outcome parameters, included intraoperative or postoperative complications. RESULTS:Seven retrospective comparative studies including 228 eyes were selected. No significant difference was detected in either postoperative BCVA (MD -0.07; 95% CI: -0.17 to 0.03; p?=?0.16) or the improvement in postoperative BCVA (MD -0.17; 95% CI: -0.50 to 0.16; p?=?0.32) between the ILM flap group and ILM peeling group. The retinal reattachment rate using inverted ILM flap was not significantly different from that using ILM peeling (odds ratio (OR) 2.24; 95% CI: 0.75-6.73; p?=?0.15). The MH closure rate was higher with inverted ILM flap than with ILM peeling (OR 11.86; 95% CI: 5.65 to 24.92; p?<?0.00001). There was no significant difference in intraoperative or postoperative complications, including concomitant cataract rate (OR 1.22; 95% CI: 0.42-3.58; p?=?0.71). CONCLUSION:The inverted ILM flap technique could contribute to a higher MH closure rate than ILM peeling, but visual improvement was similar. Both surgical methods could obtain a high-retinal reattachment rate with fewer intraoperative and postoperative complications.
Project description:PurposeTo determine whether the inverted internal limiting membrane (ILM) flap technique contributes to high reattachment and closure rates in patients with macular hole-associated retinal detachment (MHRD).Patients and methodsIn all, 15 eyes of 15 patients with MHRD undergoing 25-gauge pars plana vitrectomy with the inverted ILM flap technique or ILM peeling. The patients were divided into the inverted ILM flap technique group (6 eyes) and ILM peeling group (9 eyes). The logarithm of minimal angle of resolution best-corrected visual acuity (BCVA) and retinal attachment and macular hole closure rates were compared between the two groups before and after surgery.ResultsNo significant differences were found in the pre- and postoperative BCVA at 1 and 3 months after surgery in either group (inverted ILM flap technique group, preoperatively 1.04±0.55, 1 month 0.95±0.30, 3 months 0.83±0.22; ILM peeling group, preoperatively 1.00±0.44, 1 month 1.05±0.38, 3 months 1.06±0.49; P>0.05, respectively). The postoperative BCVA at 6 months after surgery was significantly better in the inverted ILM flap technique group than in the ILM peeling group (inverted ILM flap technique group, 0.62±0.35; ILM peeling group, 1.02±0.41, P=0.045). The improvement in BCVA was significantly better in the inverted ILM flap technique group than in the ILM peeling group (inverted ILM flap technique group, -0.41±0.29; ILM peeling group, 0.02±0.36; P=0.021). The primary macular hole closure rates were 100% in the inverted ILM flap technique group and 55.5% in the ILM peeling group. The primary reattachment rates were 100% in the inverted ILM flap technique group and 55.5% in the ILM peeling group. The primary macular hole closure and reattachment rates were not significantly different in both groups (P=0.056, respectively).ConclusionThe inverted ILM flap technique is a useful procedure for MHRD in highly myopic eyes.
Project description:BACKGROUND:A full-thickness macular hole (FTMH) is a common retinal condition associated with impaired vision. Randomised controlled trials (RCTs) have demonstrated that surgery, by means of pars plana vitrectomy and post-operative intraocular tamponade with gas, is effective for stage 2, 3 and 4 FTMH. Internal limiting membrane (ILM) peeling has been introduced as an additional surgical manoeuvre to increase the success of the surgery; i.e. increase rates of hole closure and visual improvement. However, little robust evidence exists supporting the superiority of ILM peeling compared with no-peeling techniques. The purpose of FILMS (Full-Thickness Macular Hole and Internal Limiting Membrane Peeling Study) is to determine whether ILM peeling improves the visual function, the anatomical closure of FTMH, and the quality of life of patients affected by this disorder, and the cost-effectiveness of the surgery. METHODS/DESIGN:Patients with stage 2-3 idiopathic FTMH of less or equal than 18 months duration (based on symptoms reported by the participant) and with a visual acuity </= 20/40 in the study eye will be enrolled in this FILMS from eight sites across the UK and Ireland. Participants will be randomised to receive combined cataract surgery (phacoemulsification and intraocular lens implantation) and pars plana vitrectomy with postoperative intraocular tamponade with gas, with or without ILM peeling. The primary outcome is distance visual acuity at 6 months. Secondary outcomes include distance visual acuity at 3 and 24 months, near visual acuity at 3, 6, and 24 months, contrast sensitivity at 6 months, reading speed at 6 months, anatomical closure of the macular hole at each time point (1, 3, 6, and 24 months), health related quality of life (HRQOL) at six months, costs to the health service and the participant, incremental costs per quality adjusted life year (QALY) and adverse events. DISCUSSION:FILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery. TRIAL REGISTRATION:This trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.
Project description:Optic disc pit (ODP) is a rare, congenital, cavitary anomaly of the optic disc. Usually, single ODP occurs in an eye and only eleven cases of double ODP have been reported so far in the literature. In the present study, we report a case of unilateral double ODP, with both the pits present in opposite disc segments. They were associated with serous retinal detachment at the macula and retinal pigment epithelium degeneration nasal to disc. The case was managed successfully with vitrectomy, internal limiting membrane peeling, plugging the pits with homologous partial-thickness scleral flaps, and gas tamponade.