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      Comparative study of inverted internal limiting membrane (ILM) flap and ILM peeling technique in large macular holes: a randomized-control trial

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          Abstract

          Background

          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).

          Methods

          This was a prospective randomized control trial. The study included patients with idiopathic FTMH, with a minimum diameter ranging from 600 to 1500 μm. 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.

          Results

          There were 30 patients in each group. The mean minimum diameters in Group A and B were 759.97 ± 85.01 μm and 803.33 ± 120.65 μm respectively ( p = 0.113). The mean base diameter in group A and B was 1304.50 ± 191.59 μm and 1395.17 ± 240.56 μm 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).

          Conclusion

          The anatomical and functional outcome of Inverted ILM flap technique in large FTMH is statistically similar to that seen in conventional ILM peeling.

          Trial registration

          Clinical Trials Registry – India (Indian Medical Research) CTRI/2017/11/010474.

          Electronic supplementary material

          The online version of this article (10.1186/s12886-018-0826-y) contains supplementary material, which is available to authorized users.

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          Most cited references31

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          Inverted internal limiting membrane flap technique for large macular holes.

          Zofia Michalewska, Janusz Michalewski, Ron Adelman … (2010)
          Large macular holes usually have an increased risk of surgical failure. Up to 44% of large macular holes remain open after 1 surgery. Another 19% to 39% of macular holes are flat-open after surgery. Flat-open macular holes are associated with limited visual acuity. This article presents a modification of the standard macular hole surgery to improve functional and anatomic outcomes in patients with large macular holes. A prospective, randomized clinical trial. Patients with macular holes larger than 400 μm were included. In group 1, 51 eyes of 40 patients underwent standard 3-port pars plana vitrectomy with air. In group 2, 50 eyes of 46 patients underwent a modification of the standard technique, called the inverted internal limiting membrane (ILM) flap technique. In the inverted ILM flap technique, instead of completely removing the ILM after trypan blue staining, a remnant attached to the margins of the macular hole was left in place. This ILM remnant was then inverted upside-down to cover the macular hole. Fluid-air exchange was then performed. Spectral optical coherence tomography and clinical examination were performed before surgery and postoperatively at 1 week and 1, 3, 6, and 12 months. Visual acuity and postoperative macular hole closure. Preoperative mean visual acuity was 0.12 in group 1 and 0.078 in group 2. Macular hole closure was observed in 88% of patients in group 1 and in 98% of patients in group 2. A flat-hole roof with bare retinal pigment epithelium (flat-open) was observed in 19% of patients in group 1 and 2% of patients in group 2. Mean (or median) postoperative visual acuity 12 months after surgery was 0.17 (range, 0.1-0.6) in group 1 and 0.28 (range, 0.02-0.8) in group 2 (P = 0.001). The inverted ILM flap technique prevents the postoperative flat-open appearance of a macular hole and improves both the functional and anatomic outcomes of vitrectomy for macular holes with a diameter greater than 400 μm. Spectral optical coherence tomography after vitrectomy with the inverted ILM flap technique suggests improved foveal anatomy compared with the standard surgery. Copyright © 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Macular hole size as a prognostic factor in macular hole surgery.

            M Schaumberger, Christos Haritoglou, A Gass … (2002)
            In 1991 there was a series of successful closures of a macular hole after vitrectomy and membrane peeling. Today this technique has become a standard procedure. The aim of this study was to evaluate the role of optical coherence tomography in diagnosing and staging, as well as in predicting, the functional and anatomical outcome after macular hole surgery. In a prospective study 94 consecutive patients (20 male, 74 female) with a mean age of 67.6 (SD 6.0) years and a macular hole stage II (n = 8), III (n = 72), and IV (n = 14) according to the classification by Gass were examined with optical coherence tomography (OCT) before pars plana vitrectomy. Macular hole diameters were determined at the level of the retinal pigment epithelium (base diameter) and at the minimal extent of the hole (minimum diameter). Calculated hole form factor (HFF) was correlated with the postoperative anatomical success rate and best corrected visual acuity. The duration of symptoms was correlated with base and minimum diameter of the macular hole. In eyes without anatomical closure of the macular hole after one surgical approach (13/94) the base diameter (p1) and the minimum diameter (p2) were significantly larger than in cases with immediate postsurgical closure (p1 = 0.003; p2 = 0.028). There was a significant negative correlation between both the base and the minimum diameter of the hole and the postoperative visual function (p1 = 0.016; p2 = 0.002). In all patients with HFF >0.9 the macular hole was closed following one surgical procedure, whereas in eyes with HFF <0.5 anatomical success rate was 67%. Better postoperative visual outcome correlated with higher HFF (p = 0.050). There was no significant correlation between the duration of symptoms and base or minimum diameters (p1 = 0.053; p2 = 0.164), respectively. Preoperative measurement of macular hole size with OCT can provide a prognostic factor for postoperative visual outcome and anatomical success rate of macular hole surgery. The duration of symptoms did not correlate with the diameters measured. Base and minimum diameters especially seem to be of predictive value in macular hole surgery.
            Article 0 comments Cited 102 times – based on 0 reviews     Review now
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              Types of macular hole closure and their clinical implications.

              Steven Ham, Brian S W Choo-Kang, Anthony K Ahn (2003)
              To evaluate the clinical significance of macular hole closure types assessed by optical coherence tomography (OCT). This study involved 34 eyes of 32 patients who had undergone anatomically successful idiopathic macular hole surgery. The closed macular holes were categorised into two patterns based on OCT; type 1 closure (closed without foveal neurosensory retinal defect) and type 2 closure (closed with foveal neurosensory retinal defect). Association between visual prognosis, type of hole closure, and possible prognostic factors were analysed. 19 eyes (61.3%) were classified into the type 1 closure and 12 eyes (38.7%) into the type 2 closure. The extent of postoperative visual improvement of type 1 closure group was larger than that of type 2 closure group (p=0.002). The preoperative macular hole size of type 2 closure group was significantly larger than that of type 1 closure group (p=0.006). The duration of symptoms was positively correlated with the preoperative macular hole size (p=0.01). Recurrence of macular hole occurred only in the type 2 closure group. The type of macular hole closure, which was influenced by the preoperative hole diameter, was associated with postoperative visual prognosis. Early detection and intervention in macular hole should be emphasised.
              Article 0 comments Cited 98 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Naresh Babu Kannan: cauveryeye@gmail.com
                Piyush Kohli: kohli119@gmail.com
                Haemoglobin Parida: drhaemoglobinssjs@gmail.com
                O. O. Adenuga: korexmed@yahoo.com
                Kim Ramasamy: kim@aravind.org
                Journal
                Journal ID (nlm-ta): BMC Ophthalmol
                Journal ID (iso-abbrev): BMC Ophthalmol
                Title: BMC Ophthalmology
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2415
                Publication date (Electronic): 20 July 2018
                Publication date PMC-release: 20 July 2018
                Publication date Collection: 2018
                Volume: 18
                Electronic Location Identifier: 177
                Affiliations
                ISNI 0000 0004 1767 7755, GRID grid.413854.f, Department of Vitreo-retinal services, , Aravind Eye Hospital and Post graduate Institute of Ophthalmology, ; Madurai, Tamil Nadu India
                Article
                Publisher ID: 826
                DOI: 10.1186/s12886-018-0826-y
                PMC ID: 6054750
                PubMed ID: 30029621
                SO-VID: 513aa95d-8560-4b68-9af3-8c118ec9f74e
                Copyright © © The Author(s). 2018
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 22 December 2017
                Date accepted : 14 June 2018
                Categories
                Subject: Research Article
                Custom metadata
                issue-copyright-statement © The Author(s) 2018

                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: 600 μm,inverted ilm flap,large macular hole,muller cells,type 1 closure
                Data availability:
                ScienceOpen disciplines: Ophthalmology & Optometry
                Keywords: 600 μm, inverted ilm flap, large macular hole, muller cells, type 1 closure

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