Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
NCT ID: NCT04135638
Last Updated: 2019-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2019-11-01
2020-04-10
Brief Summary
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Detailed Description
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Purpose of the study is to report retinal differential sensitivity and fixation stability as well as anatomic and visual outcomes of patients operated on for idiopathic MH and randomly assigned to Fill or Cover Groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Cover Group (CG)
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
Cover Group
"Cover" when the ILM flap is everted over the MH gap in a single layer
Fill Group (FG)
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
Fill Group
"Fill" when the ILM is folded into multiple layers within the MH
Interventions
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Cover Group
"Cover" when the ILM flap is everted over the MH gap in a single layer
Fill Group
"Fill" when the ILM is folded into multiple layers within the MH
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
80 Years
ALL
No
Sponsors
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Ospedale Policlinico San Martino
OTHER
Fondazione G.B. Bietti, IRCCS
OTHER
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
OTHER
University of Molise
OTHER
Responsible Party
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Ciro Costagliola
Full Professor in Ophthalmology
Principal Investigators
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Ciro Costagliola
Role: PRINCIPAL_INVESTIGATOR
University of Molise
Locations
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University of Molise
Campobasso, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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14738
Identifier Type: -
Identifier Source: org_study_id
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