Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a randomised controlled trial: FILMS (Full-thickness Macular Hole and Internal Limiting Membrane Peeling Study).
ABSTRACT: 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
Project description:PURPOSE:To investigate the long-term results of a modified technique for parafoveal multiple curvilinear internal limiting membrane (ILM) peeling to preserve the epi-foveal ILM in myopic foveoschisis surgery. METHODS:Thirty-two consecutive patients (36 eyes) were retrospectively reviewed. Patients were divided into two groups according to the extent of ILM peeled: the fovea-sparing ILM peeling group (FS) (18 eyes) and total ILM peeling group (TP) (18 eyes). Patients were followed up for at least 12 months. The main outcome measures were best-corrected visual acuity changes, evolution of macular schisis and the factors associated with the development of a full-thickness macular hole (FTMH). RESULTS:FTMH developed in 1 of 18 eyes (5.6%) in the FS group and 3 of 18 eyes (16.7%) in the TP group (P = 0.28). Long-term follow-up showed visual improvement was better in the FS group than in the TP group (0.94 vs. 0.58 logMAR). Macular schisis disappeared in 13 of 18 eyes (72.2%) in the FS group, but disappeared in 7 of 18 eyes (38.9%) in the TP group (P = 0.04). Logistic regression analysis showed that only the preoperative outer lamellar macular hole (P = 0.016) was a significant risk factor for development of postoperative FTMH. CONCLUSIONS:Fovea-sparing ILM peeling achieves a higher rate of macular schisis resolution over total peeling. A preoperative outer lamellar macular hole can be a risk factor for the development of a macular hole.
Project description:The anatomical success rate of macular hole surgery ranges around 93-98%. However, the prognosis of large macular holes is generally poor. The study was conducted to compare the anatomical and visual outcomes of Internal Limiting Membrane (ILM) peeling vis-a-vis inverted ILM flap for the treatment of idiopathic large Full-Thickness Macular Holes (FTMH).This was a prospective randomized control trial. The study included patients with idiopathic FTMH, with a minimum diameter ranging from 600 to 1500 ?m. The patients were randomized into Group A (ILM peeling) and Group B (inverted ILM flap). The main outcome measures were anatomical and visual outcome at the end of 6 months. Anatomical success was defined as flattening of macular hole with resolution of the subretinal cuff of fluid and neurosensory retina completely covering the fovea.There were 30 patients in each group. The mean minimum diameters in Group A and B were 759.97?±?85.01 ?m and 803.33?±?120.65 ?m respectively (p?=?0.113). The mean base diameter in group A and B was 1304.50?±?191.59 ?m and 1395.17?±?240.56 ?m respectively (p?=?0.112). The anatomical success rates achieved in Group A and B were 70.0 and 90.0% respectively (p?=?0.125). The mean best-corrected visual acuity (BCVA) after 6 months was logMAR 0.65?±?0.25 (Snellen equivalent, 20/89) in Group A and logMAR 0.53?±?0.20 (Snellen equivalent, 20/68) in Group B (p?=?0.060). The mean improvement in BCVA was 1.4 lines and 2.1 lines in groups A and B respectively (p?=?0.353). BCVA?20/60 was achieved by 13.3 and 20.0% in group A and B respectively (p?=?0.766).The anatomical and functional outcome of Inverted ILM flap technique in large FTMH is statistically similar to that seen in conventional ILM peeling.Clinical Trials Registry - India (Indian Medical Research) CTRI/2017/11/010474 .
Project description:To highlight the differences in macular pigment optical density (MPOD) between eyes with vitreoretinal interface syndrome and healthy control eyes, to assess the changes in MPOD in eyes treated with macular peeling, to investigate the relationships between MPOD changes and measures of retinal sensitivity such as best corrected visual acuity (BCVA) and microperimetry.In this cross-sectional comparative study, 30 eyes affected by idiopathic epiretinal membrane (iERM, 15eyes) or full-thickness macular hole (FTMH, 15eyes) were compared with 60 eyes from 30 healthy age-matched patients. MPOD values (mean MPOD, maximum MPOD, MPOD area, and MPOD volume) were measured in a range of 4°-7° of eccentricity around the fovea, using the one-wavelength reflectometry method (Visucam 200, Carl-Zeiss Meditec). Patients affected by iERM and FTMH were treated with vitrectomy and epiretinal membrane-inner limiting membrane (ERM-ILM) peeling, with follow-up examinations performed preoperatively and 6 months postoperatively. The main outcome measures were the differences in MPOD between eyes with vitreoretinal interface syndrome and healthy eyes, changes in MPOD after ERM-ILM peeling, and relationships between MPOD and functional changes.Mean MPOD differed significantly between control eyes and those with iERM (P = .0001) or FTMH (P = .0006). The max MPOD and MPOD area increased, but not significantly. After peeling, the only significant change in MPOD was in MPOD volume (P = .01). In the ERM group, postoperative mean MPOD correlated significantly with best-corrected visual acuity (r = .739, P = .002).MPOD was reduced in patients with iERM or FTMH compared with healthy eyes. We found a significant correlation between the mean postoperative MPOD and postoperative BCVA, hypothesizing that the postoperative increase in mean MPOD could be due to a change in distribution for unfolding and expansion of the fovea after the peeling. MOPD may be considered as a prognostic factor associated with a good visual prognosis in patients with iERM.
Project description:Purpose:To examine the relationship between the morphological and functional results in eyes after pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling due to stage 4 full-thickness macular hole (FTMH). Methods:The study included 22 eyes that underwent successful PPV due to FTMH. Both vertical metamorphopsia (VM) and horizontal metamorphopsia (HM) were determined using type 2 M-charts, as well as best-corrected visual acuity (BCVA), microperimetry, and optical coherence tomography (OCT) were performed before PPV and 1 and 6?months postoperatively. Results:A significant improvement of BCVA and metamorphopsia scores measured by M-charts in particular periods before surgery, 1 and 6?months after PPV, was observed. The VM scores were consistently higher than the HM scores at all assessment times. There was a correlation found between VM and BCVA and microperimetry parameters before surgery. The macular sensitivity (MS) as well as macular integrity index increased from 1?month to 6?months after PPV and were correlated with postoperative visual acuity (VA). There was a correlation found between the hole diameter and MS and P2 parameter 6?months after PPV. There was a correlation found between mean duration of symptoms of FTMH and VA and VM score. Conclusions:VM scores seem to correlate better than HM scores with preoperative BCVA, microperimetry parameters, and duration of symptoms of the FTMH. VM scores are higher after PPV than HM scores in patients with stage 4 of the FTMH. This trial is registered with NCT03701542.
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:To evaluate macular retinal ganglion cell-inner plexiform layer (GCIPL) thickness after vitrectomy with internal limiting membrane (ILM) peeling for idiopathic macular holes using spectral domain optical coherence tomography (SD-OCT).Eighteen eyes of 18 patients with unilateral idiopathic macular hole who underwent vitrectomy with ILM peeling were retrospectively analyzed. Healthy fellow eyes of the patients and 18 eyes of 18 age-matched healthy individuals constituted the control group. The patients were evaluated at 1 day, 1 week, 1 month, and 3 months after surgery. The best corrected visual acuity (BCVA) measurements, biomicroscopic examination findings and SD-OCT measurements were recorded. Ganglion cell-inner plexiform layer thickness was evaluated with ganglion cell analysis software of Cirrus HD-OCT before surgery and at 1 month and 3 months after surgery and compared with control groups. Presence of dissociated optic nerve fiber layer (DONFL) was evaluated with C-scan mode.Of the 18 patients, 9 were male and 9 were female with a mean age of 65.6±5.6 (55-77) years. Preoperative BCVA was 0.75±0.19 logMAR, while it was 0.44±0.17 logMAR and 0.36±0.15 logMAR at postoperative 1 and 3 months, respectively (p<0.001). Postoperative mean GCIPL thickness was 66.33±17.28 µm. There was a correlation between mean GCIPL thickness and BCVA at postoperative 3 months (p<0.01). When compared with the control group, GCIPL thickness was significantly thinner in all quadrants of all patients at postoperative 3 months. Dissociated optic nerve fiber layer appearance was observed on C-scan in 13 of 18 eyes postoperatively. There was no correlation between the presence of DONFL and BCVA (p>0.05).Internal limiting membrane peeling during macular hole surgery may cause functional and/or structural changes that may be associated with visual acuity. Significant GCIPL thinning and DONLF appearance may occur postoperatively.
Project description:BACKGROUND:The epiretinal membrane (ERM) is a degenerative condition associated with age, which can cause loss of vision and/or metamorphopsia. The treatment of symptomatic ERM involves surgical removal including a vitrectomy followed by peeling of the ERM using a microforceps. As the internal limiting membrane (ILM) is adherent to the ERM, it is sometimes removed with it (spontaneous peeling). If ILM remains in place, it can be removed to reduce ERM recurrence. However, it is important to clarify the safety of ILM peeling, while it increases surgical risks and cause histological disorganization of the retina that can lead to microscotomas, may be responsible for definitive visual discomfort. METHODS:PEELING is a prospective, randomized, controlled, single-blind, and multicentered trial with two parallel arms. This study investigates the benefit/risk ratio of active ILM peeling among individuals undergoing ERM surgery without spontaneous ILM peeling. Randomization is done in the operating room after ERM removal if ILM remains in place. After randomization, the two groups-"active peeling of the ILM" and "no peeling of the ILM"-are compared during a total of three follow-up visits scheduled at month 1, month 6, and month 12. Primary endpoint is the difference in microscotomas before surgery and 6?months after surgery. Patients with spontaneous peeling are not randomized and are included in the ancillary study with the same follow-up visits and the same examinations as the principal study. Relevant inclusion criteria involve individuals aged >?18?years living with idiopathic symptomatic ERM, including pseudophakic patients with transparent posterior capsule or open capsule or lensed patients with age-related cataracts. The calculated sample size corresponds to 53 randomized eyes (one eye/patient) per arm that means 106 randomized eyes (106 randomized patients) in total and a maximum of 222 included patients (116 spontaneous peeling). DISCUSSION:ILM peeling is often practiced in ERM surgery to reduce ERM recurrence. It does not impair postoperative visual acuity, but it increases the surgical risks and causes anatomical damages. If active ILM peeling is significantly associated with more microscotomas, it may contraindicate the ILM peeling during primitive idiopathic ERM surgery. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02146144. Registered on 22 May 2014. Recruitment is still ongoing.
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:Differences in the pathogenesis and clinical characteristics between lamellar macular hole (LMH) with and without LMH-associated epiretinal proliferation (LHEP) can have surgical implications. This study investigated the effects of treating LHEP by foveolar internal limiting membrane (ILM) non-peeling and epiretinal proliferative (EP) tissue repositioning on visual acuity and foveolar architecture. Consecutive patients with LHEP treated at our institution were enrolled. The eyes were divided into a conventional total ILM peeling group (group 1, n?=?11) and a foveolar ILM non-peeling group (group 2, n?=?22). In group 2, a doughnut-shaped ILM was peeled, leaving a 400-?m-diameter ILM without elevated margin over the foveola after EP tissue repositioning. The EP tissue was elevated, trimmed, and inverted into the LMH. Postoperatively, the LMH was sealed in all eyes in group 2, with significantly better best-corrected visual acuity (-0.26 vs -0.10 logMAR; p?=?0.002). A smaller retinal defect (p?=?0.003), a more restored ellipsoid zone (p?=?0.002), and a more smooth foveal depression (p?<?0.001) were achieved in group 2. Foveolar ILM non-peeling and EP tissue repositioning sealed the LMH, released the tangential traction, and achieved better visual acuity. The presumed foveolar architecture may be reconstructed surgically. LMH with LHEP could have a combined degenerative and tractional mechanism.
Project description:<h4>Background</h4>Internal limiting membrane (ILM) peeling increases the idiopathic macular hole (IMH) closure rate but causes the inner retina dimplings. This study is to introduce a method to minimally peel the ILM, and with the ILM flap to ensure the IMH closure.<h4>Methods</h4>Twelve consecutive IMH eyes were treated with the minimal ILM peeling with ILM flap technique. The ILM around the MH is peeled off in an annular shape with a width of approximately 200 to 300??m. A tongue-shape ILM flap is created in the superior retina and the inferior margin of ILM is not peeled off. The ILM flap is then inverted to cover the MH, followed by fluid-air exchange and air or silicon tamponade. Spectral domain-optical coherence tomography (SD-OCT) and en face OCT for morphological assessment, best corrected visual acuity (BCVA) and multifocal electroretinogram (ERG) for functional evaluation were performed at baseline and at each postoperative follow-up.<h4>Results</h4>All the 12 eyes achieved macular hole closure on SD-OCT after surgery (100%). At baseline, the mean preoperative BCVA was 0.83?±?0.33 and it improved to 0.39?±?0.28 postoperatively (p?<? 0.001). En face OCT showed the inner retinal dimplings were localized only in superior ILM-free retinas (7 eyes). The mERG response density in the central (R1), para-central (R2), R1/R2 ring ratios were remarkably improved at the last follow-up (p?=?0.001, p?=?0.033, p?=?0.018, respectively).<h4>Conclusions</h4>The minimal ILM peeling with ILM flap technique can achieve favorable MH closure with less inner retinal dimplings and has promising visual recovery for IMH eyes.