Back to resultsInverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
Primary Purpose
Macular Holes
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cover Group
Fill Group
Sponsored by
About this trial
This is an interventional other trial for Macular Holes
Eligibility Criteria
Inclusion Criteria:
- patients with idiopatic macular holes
Exclusion Criteria:
- 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
Sites / Locations
- University of MoliseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cover Group (CG)
Fill Group (FG)
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Macular sensitivity linked to "Cover" and "Fill" procedures
To report:
Retinal Sensitivity (RS expressed in dB)
Fixation Stability (FS expressed as: 0 = stable, 1 = relatively (stable,2 = unstable)
of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.
Full Information
NCT ID
NCT04135638
First Posted
October 4, 2019
Last Updated
October 19, 2019
Sponsor
University of Molise
Collaborators
Ospedale Policlinico San Martino, Fondazione G.B. Bietti, IRCCS, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
1. Study Identification
Unique Protocol Identification Number
NCT04135638
Brief Title
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
Official Title
Comparing Retinal Sensitivity and Fixation Stability of Inverted ILM-flap Techniques Variants for Macular Hole Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
April 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Molise
Collaborators
Ospedale Policlinico San Martino, Fondazione G.B. Bietti, IRCCS, Università degli Studi 'G. d'Annunzio' Chieti e Pescara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients will be randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. "Cover" when the ILM flap is everted over the MH gap in a single layer, "Fill" when the ILM is folded into multiple layers within the MH. All patients will undergo BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Holes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cover Group (CG)
Arm Type
Other
Arm Description
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
Arm Title
Fill Group (FG)
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Cover Group
Intervention Description
"Cover" when the ILM flap is everted over the MH gap in a single layer
Intervention Type
Procedure
Intervention Name(s)
Fill Group
Intervention Description
"Fill" when the ILM is folded into multiple layers within the MH
Primary Outcome Measure Information:
Title
Visual outcome linked to "Cover" and "Fill" procedures
Description
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.
Time Frame
five months
Title
Anatomical outcome linked to "Cover" and "Fill" procedures
Description
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
Time Frame
five months
Secondary Outcome Measure Information:
Title
Macular sensitivity linked to "Cover" and "Fill" procedures
Description
To report:
Retinal Sensitivity (RS expressed in dB)
Fixation Stability (FS expressed as: 0 = stable, 1 = relatively (stable,2 = unstable)
of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure.
Time Frame
five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with idiopatic macular holes
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ciro Costagliola, MD
Phone
+390874404448
Email
ciro.costagliola@unimol.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ciro Costagliola
Organizational Affiliation
University of Molise
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Molise
City
Campobasso
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Costagliola Ciro
Phone
08744092269
Email
ciro.costagliola@unimol.it
12. IPD Sharing Statement
Citations:
PubMed Identifier
2025167
Citation
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.
Results Reference
background
PubMed Identifier
20541263
Citation
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.
Results Reference
background
PubMed Identifier
28161828
Citation
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.
Results Reference
background
PubMed Identifier
28991503
Citation
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.
Results Reference
background
PubMed Identifier
22466479
Citation
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.
Results Reference
background
PubMed Identifier
23620091
Citation
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.
Results Reference
background
PubMed Identifier
28993905
Citation
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.
Results Reference
background
PubMed Identifier
29020427
Citation
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.
Results Reference
background
PubMed Identifier
29232338
Citation
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.
Results Reference
background
PubMed Identifier
30284091
Citation
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.
Results Reference
background
PubMed Identifier
22441811
Citation
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.
Results Reference
background
PubMed Identifier
18757517
Citation
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.
Results Reference
background
PubMed Identifier
32985592
Citation
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.
Results Reference
derived
Learn more about this trial
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
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