Dataset Information

The impact of extent of internal limiting membrane peeling on anatomical outcomes of macular hole surgery: results of a 54-week randomized clinical trial.

ABSTRACT:

Purpose

To compare the anatomical outcomes of different extents of internal limiting membrane (ILM) peeling in idiopathic macular hole surgery.

Methods

Prospective, parallel-group, randomized clinical trial. A total of 121 eyes of 121 patients with idiopathic macular hole underwent pars plana vitrectomy, and peeling of the ILM with a diameter of two disk diameters (DD) or 4DD based on randomization. The main outcome was the proportion of eyes with complete hole closure at 12 months. The second outcome was the hole closure grading stratified by macular hole closure index (MHCI) at each visit.

Results

At 12 months, there was no significant difference in anatomical outcomes with complete closure achieved in 52 (82.5%) of 63 eyes in the 2DD group and 53 (91.4%) of 58 eyes in the 4DD group (p = 0.15). For subjects with MHCI ≤0.5 (n = 24), complete closure rate was significantly lower in the 2DD group compared to the 4DD group (p = 0.012; 18.2% versus 75.9%, respectively). Average BCVA was lower in 2DD group than 4DD group (p = 0.014). By contrast, when MHCI was >0.5, the complete closure rate between the two groups showed no significant difference: 96.2% (50 patients) versus 95.6% (43 patients), respectively (p = 0.185).

Conclusion

In patients with idiopathic full-thickness macular hole and MHCI ≤0.5, a larger ILM peel of 4DD tends to achieve better anatomical outcomes than a more limited 2DD peel.

SUBMITTER: Yao Y

PROVIDER: S-EPMC6585771 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Publications

The impact of extent of internal limiting membrane peeling on anatomical outcomes of macular hole surgery: results of a 54-week randomized clinical trial.

Yao Yuou Y Qu Jinfeng J Dong Chongya C Li Xiaoxin X Liang Jianhong J Yin Hong H Huang Lvzhen L Li Yan Y Liu Peipei P Pan Chungting C Ding Xue X Song Dan D Sadda Srinivas R SR Zhao Mingwei M

Acta ophthalmologica 20180905 3

<h4>Purpose</h4>To compare the anatomical outcomes of different extents of internal limiting membrane (ILM) peeling in idiopathic macular hole surgery.<h4>Methods</h4>Prospective, parallel-group, randomized clinical trial. A total of 121 eyes of 121 patients with idiopathic macular hole underwent pars plana vitrectomy, and peeling of the ILM with a diameter of two disk diameters (DD) or 4DD based on randomization. The main outcome was the proportion of eyes with complete hole closure at 12 month ...[more]

PMID: 30187641

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Project description:BackgroundA 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/designPatients 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.DiscussionFILMS will provide high quality evidence on the role of ILM peeling in FTMH surgery.Trial registrationThis trial is registered with Current Controlled Trials ISRCTN number 33175422 and Clinical Trials.gov identifier NCT00286507.

Project description:BackgroundThe internal limiting membrane (ILM) insertion technique was widely used to treat large macular hole (MH) for the high closure rate. However, the prognosis of closed MH after ILM insertion compared to ILM peeling remains controversial. This study aimed to compare foveal microstructure and microperimeter in large idiopathic MH surgically closed by ILM peeling and ILM insertion.MethodsThis retrospective, non-randomized, comparative study included patients with idiopathic MH (minimum diameter ≥ 650 μm) who underwent primary pars plana vitrectomy (PPV) with ILM peeling or ILM insertion. The initial closure rate was recorded. Patients with initially closed MHs were divided into two groups according to the surgery methods. The best-corrected visual acuity (BCVA), optical coherence tomography (OCT) and microperimeter-3 (MP-3) outcomes of two groups were compared at baseline, 1 and 4 months postoperatively.ResultsFor idiopathic MH (minimum diameter ≥ 650 μm), ILM insertion had a significantly higher initial closure rate than ILM peeling (71.19% vs. 97.62%, P = 0.001). Among 39 patients with initially closed MHs who were on regular follow-up, twenty-one were assigned to the ILM peeling group and 18 to the ILM insertion group. Postoperative BCVA improved significantly in both groups. The final BCVA (logMAR) (0.40 vs. 0.88, P < 0.001), macular hole sensitivity (19.66 dB vs. 14.14 dB, P < 0.001), peripheral sensitivity of macular hole (24.63 dB vs. 21.95 dB, P = 0.005), and fixation stability (FS) within 2 degrees (82.42% vs. 70.57%, P = 0.031) were significantly better and external limiting membrane (ELM) defect (330.14 μm vs. 788.28 μm, P < 0.001) and ellipsoid zone (EZ) defect (746.95 μm vs. 1105.11 μm, P = 0.010) were significantly smaller in the ILM peeling group than in the ILM insertion group.ConclusionFor initially closed MHs (minimum diameter ≥ 650 μm), both ILM peeling and ILM insertion significantly improved the microstructure and microperimeter in the fovea. However, ILM insertion was less efficient at microstructural and functional recovery after surgery.

Dataset Information

The impact of extent of internal limiting membrane peeling on anatomical outcomes of macular hole surgery: results of a 54-week randomized clinical trial.

Purpose

Methods

Results

Conclusion

Publications

The impact of extent of internal limiting membrane peeling on anatomical outcomes of macular hole surgery: results of a 54-week randomized clinical trial.

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