Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison

NCT04135638 | Unknown

• 1 other identifier: 14738
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (2)

• Visual outcome linked to "Cover" and "Fill" procedures

  To report : \- Best Corrected Visual Acuity (BCVA expressed in logMAR) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.

  five months

• Anatomical outcome linked to "Cover" and "Fill" procedures

  To report: \- closure rate (μm) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure

  five months

Secondary Outcomes (1)

• Macular sensitivity linked to "Cover" and "Fill" procedures

  five months

Study Arms (2)

Cover Group (CG)

OTHER

All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim. Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag. In the Cover Group the ILM flap will be folded as a single layer to bridge tissue dehiscence during air-fluid exchange. All eyes will recive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative

Procedure: Cover Group

Fill Group (FG)

OTHER

All patients will undergo a 25G standard 3-port PPV with posterior vitreous detachment induction (if not already present), ILM staining with 0,25 g/l of brilliant blue-G and creation of a 360°ILM flap around the MH rim. Phakic patients will undergo combined phacoemulsification with IOL implant in-the-bag. In the Fill Group, multiple layers of ILM will be deliberately folded within the loss of tissue before air-fluid exchange. All eyes will receive a mixture of 20% sulfur hexafluoride tamponade and will be instructed to position face down for 4 hours a day during the first 3 days post-operative

Procedure: Fill Group

Interventions

Cover Group PROCEDURE

"Cover" when the ILM flap is everted over the MH gap in a single layer

Cover Group (CG)

Fill Group PROCEDURE

"Fill" when the ILM is folded into multiple layers within the MH

Fill Group (FG)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with idiopatic macular holes

You may not qualify if:

• Patients with MH duration greater than 6 months
• myopia exceeding 6 diopters
• history of trauma
• previous ocular surgery except uncomplicated cataract extraction with in-the-bag IOL implantation
• any ocular illness including glaucoma, uveitis, optic nerve pathology

Sponsors & Collaborators

• University of Molise: lead
• Ospedale Policlinico San Martino: collaborator
• Fondazione G.B. Bietti, IRCCS: collaborator
• Università degli Studi 'G. d'Annunzio' Chieti e Pescara: collaborator

Study Sites (1)

University of Molise

Campobasso, Italy

RECRUITING

Related Publications (13)

• Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.

  PMID: 2025167 BACKGROUND

• Michalewska Z, Michalewski J, Adelman RA, Nawrocki J. Inverted internal limiting membrane flap technique for large macular holes. Ophthalmology. 2010 Oct;117(10):2018-25. doi: 10.1016/j.ophtha.2010.02.011. Epub 2010 Jun 11.

  PMID: 20541263 BACKGROUND

• Rossi T, Gelso A, Costagliola C, Trillo C, Costa A, Gesualdo C, Ripandelli G. Macular hole closure patterns associated with different internal limiting membrane flap techniques. Graefes Arch Clin Exp Ophthalmol. 2017 Jun;255(6):1073-1078. doi: 10.1007/s00417-017-3598-9. Epub 2017 Feb 4.

  PMID: 28161828 BACKGROUND

• Molina-Martin A, Perez-Cambrodi RJ, Pinero DP. Current Clinical Application of Microperimetry: A Review. Semin Ophthalmol. 2018;33(5):620-628. doi: 10.1080/08820538.2017.1375125. Epub 2017 Oct 9.

  PMID: 28991503 BACKGROUND

• Chen WC, Wang Y, Li XX. Morphologic and functional evaluation before and after successful macular hole surgery using spectral-domain optical coherence tomography combined with microperimetry. Retina. 2012 Oct;32(9):1733-42. doi: 10.1097/IAE.0b013e318242b81a.

  PMID: 22466479 BACKGROUND

• Bonnabel A, Bron AM, Isaico R, Dugas B, Nicot F, Creuzot-Garcher C. Long-term anatomical and functional outcomes of idiopathic macular hole surgery. The yield of spectral-domain OCT combined with microperimetry. Graefes Arch Clin Exp Ophthalmol. 2013 Nov;251(11):2505-11. doi: 10.1007/s00417-013-2339-y. Epub 2013 Apr 26.

  PMID: 23620091 BACKGROUND

• Chen SN. Large semicircular inverted internal limiting membrane flap in the treatment of macular hole in high myopia. Graefes Arch Clin Exp Ophthalmol. 2017 Dec;255(12):2337-2345. doi: 10.1007/s00417-017-3808-5. Epub 2017 Oct 10.

  PMID: 28993905 BACKGROUND

• Aurora A, Seth A, Sanduja N. Cabbage Leaf Inverted Flap ILM Peeling for Macular Hole: A Novel Technique. Ophthalmic Surg Lasers Imaging Retina. 2017 Oct 1;48(10):830-832. doi: 10.3928/23258160-20170928-08.

  PMID: 29020427 BACKGROUND

• Rizzo S, Tartaro R, Barca F, Caporossi T, Bacherini D, Giansanti F. INTERNAL LIMITING MEMBRANE PEELING VERSUS INVERTED FLAP TECHNIQUE FOR TREATMENT OF FULL-THICKNESS MACULAR HOLES: A COMPARATIVE STUDY IN A LARGE SERIES OF PATIENTS. Retina. 2018 Sep;38 Suppl 1:S73-S78. doi: 10.1097/IAE.0000000000001985.

  PMID: 29232338 BACKGROUND

• Wang Z, Qi Y, Liang X, Yu Y, Chen J, Wang J, Liu X, Liu W. MP-3 measurement of retinal sensitivity in macular hole area and its predictive value on visual prognosis. Int Ophthalmol. 2019 Sep;39(9):1987-1994. doi: 10.1007/s10792-018-1032-x. Epub 2018 Oct 3.

  PMID: 30284091 BACKGROUND

• Sun Z, Gan D, Jiang C, Wang M, Sprecher A, Jiang AC, Xu G. Effect of preoperative retinal sensitivity and fixation on long-term prognosis for idiopathic macular holes. Graefes Arch Clin Exp Ophthalmol. 2012 Nov;250(11):1587-96. doi: 10.1007/s00417-012-1997-5. Epub 2012 Mar 24.

  PMID: 22441811 BACKGROUND

• Tarita-Nistor L, Gonzalez EG, Mandelcorn MS, Lillakas L, Steinbach MJ. Fixation stability, fixation location, and visual acuity after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):84-9. doi: 10.1167/iovs.08-2342. Epub 2008 Aug 29.

  PMID: 18757517 BACKGROUND

• Cacciamani A, Gelso A, Di Nicola M, Scarinci F, Ripandelli G, Costagliola C, Rossi T. Inverted ILM-flap techniques variants for macular hole surgery: randomized clinical trial to compare retinal sensitivity and fixation stability. Sci Rep. 2020 Sep 28;10(1):15832. doi: 10.1038/s41598-020-72774-1.

  PMID: 32985592 DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Ciro Costagliola

  University of Molise

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ciro Costagliola, MD

CONTACT

+390874404448; ciro.costagliola@unimol.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Ophthalmology

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 22, 2019
• Study Start: November 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: April 10, 2020
• Last Updated: October 22, 2019

Record last verified: 2019-10

Locations

IT (1)