Vitrectomy with Internal Limiting Membrane Peeling versus No Peeling for Idiopathic Full-Thickness Macular Hole

doi:10.1016/j.ophtha.2013.10.020

Ophthalmology

Volume 121, Issue 3, March 2014, Pages 649-655

https://doi.org/10.1016/j.ophtha.2013.10.020 Get rights and content

Objective

To determine whether internal limiting membrane (ILM) peeling improves anatomic and functional outcomes of full-thickness macular hole (FTMH) surgery when compared with the no-peeling technique.

Design

Systematic review and individual participant data (IPD) meta-analysis undertaken under the auspices of the Cochrane Eyes and Vision Group. Only randomized controlled trials (RCTs) were included.

Participants and Controls

Patients with idiopathic stage 2, 3, and 4 FTMH undergoing vitrectomy with or without ILM peeling.

Intervention

Macular hole surgery, including vitrectomy and gas endotamponade with or without ILM peeling.

Main Outcome Measures

Primary outcome was best-corrected distance visual acuity (BCdVA) at 6 months postoperatively. Secondary outcomes were BCdVA at 3 and 12 months; best-corrected near visual acuity (BCnVA) at 3, 6, and 12 months; primary (after a single surgery) and final (after >1 surgery) macular hole closure; need for additional surgical interventions; intraoperative and postoperative complications; patient-reported outcomes (PROs) (EuroQol-5D and Vision Function Questionnaire-25 scores at 6 months); and cost-effectiveness.

Results

Four RCTs were identified and included in the review. All RCTs were included in the meta-analysis; IPD were obtained from 3 of the 4 RCTs. No evidence of a difference in BCdVA at 6 months was detected (mean difference, −0.04; 95% confidence interval [CI], −0.12 to 0.03; P = 0.27); however, there was evidence of a difference in BCdVA at 3 months favoring ILM peeling (mean difference, −0.09; 95% CI, −0.17 to −0.02; P = 0.02). There was evidence of an effect favoring ILM peeling with regard to primary (odds ratio [OR], 9.27; 95% CI, 4.98–17.24; P < 0.00001) and final macular hole closure (OR, 3.99; 95% CI, 1.63–9.75; P = 0.02) and less requirement for additional surgery (OR, 0.11; 95% CI, 0.05–0.23; P < 0.00001), with no evidence of a difference between groups with regard to intraoperative or postoperative complications or PROs. The ILM peeling was found to be highly cost-effective.

Conclusions

Available evidence supports ILM peeling as the treatment of choice for patients with idiopathic stage 2, 3, and 4 FTMH.

Section snippets

Methods

We undertook a systematic review and meta-analysis using individual participant data (IPD) under the auspices of the Cochrane Eyes and Vision Group.¹²

Search Results

The search strategy resulted in 172 titles and abstracts (Fig 1). Four RCTs were identified16, 17, 18, 19, 20; IPD were received from 3 RCTs.16, 17, 18 One RCT had been published only in an abstract form (ARVO Meeting Abstracts 2009;50:5206), and no IPD were available at the time this systematic review and IPD meta-analysis were undertaken. Data from this published abstract could be used for 1 outcome (macular hole closure). The number of patients (eyes) included in the IPD meta-analysis were

Discussion

This was a successful IPD collaboration that enabled the inclusion of results from 3 of the 4 identified randomized trials. This allowed more precise results than for a single study alone, and we have increased the generalizability of the results by including a range of international studies. We also were able to use the IPD to adjust our results for important covariates. We hope to update the review with results from the fourth trial once these data have been published.

Four RCTs16, 17, 18

References (29)

S.L. Lim et al.
Update on current surgical management of idiopathic macular holes
Clin Eye Vis Care
(2000)
W.E. Smiddy et al.
Internal limiting membrane peeling in macular hole surgery
Ophthalmology
(2001)
H.L. Brooks
Macular hole surgery with and without internal limiting membrane peeling
Ophthalmology
(2000)
E. Abdelkader et al.
Internal limiting membrane peeling in vitreo-retinal surgery
Surv Ophthalmol
(2008)
L. Cheng et al.
Effects of preoperative and postoperative epiretinal membranes on macular hole closure and visual restoration
Ophthalmology
(2002)
C. Haritoglou et al.
Macular changes after peeling of the internal limiting membrane in macular hole surgery
Am J Ophthalmol
(2001)
A. Uemura et al.
Visual field defects after uneventful vitrectomy for epiretinal membrane with indocyanine green-assisted internal limiting membrane peeling
Am J Ophthalmol
(2003)
R.N. Johnson et al.
Idiopathic macular holes. Observations, stages of formation, and implications for surgical intervention
Ophthalmology
(1988)
R. Tadayoni et al.
A randomized controlled trial of alleviated positioning after small macular hole surgery
Ophthalmology
(2011)
R. Tadayoni et al.
Dissociated optic nerve fiber layer appearance of the fundus after idiopathic epiretinal membrane removal
Ophthalmology
(2001)

Y. Ito et al.

Dissociated optic nerve fiber layer appearance after internal limiting membrane peeling for idiopathic macular holes

Ophthalmology

(2005)

C.A. Gass et al.

Functional outcome of macular hole surgery with and without indocyanine green-assisted peeling of the internal limiting membrane

Graefes Arch Clin Exp Ophthalmol

(2003)

C. Eckardt et al.

Removal of the internal limiting membrane in macular holes. Clinical and morphological findings [in German]

Ophthalmologe

(1997)

H.S. Yooh et al.

Ultrastructural features of tissue removed during idiopathic macular hole surgery

Am J Ophthalmol

(1996)

Cited by (167)

Dissociated Optic Nerve Fiber Layer Appearance after Macular Hole Surgery: A Randomized Controlled Trial Comparing the Temporal Inverted Internal Limiting Membrane Flap Technique with Conventional Peeling
2023, Ophthalmology Retina
To evaluate the effect of the temporal inverted internal limiting membrane (ILM) flap technique compared with that of conventional ILM peeling on the extent of the dissociated optic nerve fiber layer (DONFL) and retinal sensitivity in patients undergoing macular hole (MH) surgery.
Single-center, prospective, open-label, randomized controlled clinical trial.
Patients requiring vitrectomy for MHs sized > 250 μm.
Patients were randomly assigned (1:1) to 1 of the following 2 groups: (1) the control group undergoing standard ILM peeling and (2) the experimental group (flap group) undergoing the temporal inverted ILM flap technique.
The primary outcome measure was the total DONFL score at 3 months after surgery. Important secondary outcomes were microperimetry results, primary MH closure rate, external limiting membrane (ELM) and ellipsoid zone (EZ) recovery rates, and best-corrected visual acuity (BCVA).
Sixty-five patients were recruited between February 2018 and July 2020; primary outcome data were available for 60 patients. The median DONFL score was 7.0 (3.0–12.5) in the control group and 5.0 (1.5–8.5) in the flap group at 3 months after surgery (P = 0.145). The focal depressions characteristic of the DONFL were limited to the temporal side of the fovea in the flap group, whereas they were found all around the fovea in the control group on spectral-domain OCT images. The MH closure rate (P = 1), EZ and ELM recovery rates (P = 0.252), and BCVA (P = 0.450) were similar between the 2 groups. The 3-month overall median retinal sensitivity (MRS) (P = 0.142) and MRS improvement (P = 0.916) in the control group were comparable with those observed in the flap group. In addition, there was no significant difference between the 2 techniques when considering the temporal area (P = 0.105) or the nasal area (P = 0.468).
The temporal inverted ILM flap technique reduced the extent of the DONFL by preserving the nasal part of the fovea. However, the overall DONFL score was similar between the 2 techniques. In addition, the MRS and BCVA did not differ from those obtained after complete ILM peeling.
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
The Effect of Macular Hole Duration on Surgical Outcomes: An Individual Participant Data Study of Randomized Controlled Trials
2023, Ophthalmology
Citation Excerpt :
We attempted to contact all corresponding authors via email and requires IPD from their study participants. In total, 12 studies provided IPD that represented 940 eyes.25,28,33–37,40-44 All authors who replied were willing to share data.
To define the effect of symptom duration on outcomes in people undergoing surgery for idiopathic full-thickness macular holes (iFTMHs) by means of an individual participant data (IPD) study of randomized controlled trials (RCTs). The outcomes assessed were primary iFTMH closure and postoperative best-corrected visual acuity (BCVA).
Idiopathic full-thickness macular holes are visually disabling with a prevalence of up to 0.5%. Untreated BCVA is typically reduced to 20/200. Surgery can close holes and improve vision. Symptom duration is thought to affect outcomes with surgery, but the effect is unclear.
A systematic review identified eligible RCTs that included adults with iFTMH undergoing vitrectomy with gas tamponade in which symptom duration, primary iFTMH closure, and postoperative BCVA were recorded. Bibliographic databases were searched for articles published between 2000 and 2020. Individual participant data were requested from eligible studies.
Twenty eligible RCTs were identified. Data were requested from all studies and obtained from 12, representing 940 eyes in total. Median symptom duration was 6 months (interquartile range, 3–10). Primary closure was achieved in 81.5% of eyes. There was a linear relationship between predicted probability of closure and symptom duration. Multilevel logistic regression showed each additional month of duration was associated with 0.965 times lower odds of closure (95% confidence interval [CI], 0.935–0.996, P = 0.026). Internal limiting membrane (ILM) peeling, ILM flap use, better preoperative BCVA, face-down positioning, and smaller iFTMH size were associated with increased odds of primary closure. Median postoperative BCVA in eyes achieving primary closure was 0.48 logarithm of the minimum angle of resolution (logMAR) (20/60). Multilevel logistic regression showed for eyes achieving primary iFTMH closure, each additional month of symptom duration was associated with worsening BCVA by 0.008 logMAR units (95% CI, 0.005–0.011, P < 0.001) (i.e., ∼1 Early Treatment Diabetic Retinopathy Study letter loss per 2 months). ILM flaps, intraocular tamponade using long-acting gas, better preoperative BCVA, smaller iFTMH size, and phakic status were also associated with improved postoperative BCVA.
Symptom duration was independently associated with both anatomic and visual outcomes in persons undergoing surgery for iFTMH. Time to surgery should be minimized and care pathways designed to enable this.
Ophthalmologists’ assessment of the handling characteristics of the novel Finesse Reflex Handle in comparison to those of a conventional handle
2024, Scientific Reports
Efficiency and safety of internal limiting membrane peeling with different forceps for macular disease
2024, Retina
Selective vital dyes in macular surgery: Do they increase the probability of intraoperative identification of the internal limiting membrane also for an experienced surgeon?
2024, Ophthalmologie
FULL-THICKNESS MACULAR HOLE CLOSURE WITH TOPICAL MEDICAL THERAPY
2024, Retina

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: Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

: Funding: NHS Grampian Endowments Grant. The NHS Grampian had no role in the design and conduct of this research.

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Original articleVitrectomy with Internal Limiting Membrane Peeling versus No Peeling for Idiopathic Full-Thickness Macular Hole

Objective

Design

Participants and Controls

Intervention

Main Outcome Measures

Results

Conclusions

Section snippets

Methods

Search Results

Discussion

Clin Eye Vis Care

Ophthalmology

Ophthalmology

Surv Ophthalmol

Ophthalmology

Am J Ophthalmol

Am J Ophthalmol

Ophthalmology

Ophthalmology

Ophthalmology

Ophthalmology

Functional outcome of macular hole surgery with and without indocyanine green-assisted peeling of the internal limiting membrane

Graefes Arch Clin Exp Ophthalmol

Removal of the internal limiting membrane in macular holes. Clinical and morphological findings [in German]

Ophthalmologe

Ultrastructural features of tissue removed during idiopathic macular hole surgery

Am J Ophthalmol

Original article
Vitrectomy with Internal Limiting Membrane Peeling versus No Peeling for Idiopathic Full-Thickness Macular Hole