Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
NCT ID: NCT03888625
Last Updated: 2019-03-25
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
60 participants
INTERVENTIONAL
2018-06-15
2020-06-30
Brief Summary
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Detailed Description
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OCT images will be performed in the first 5 postoperative days and months 1, 3 and 6.
The primary outcome is anatomic closure of the MH closure in the month 6. The second outcomes are: mean best corrected visual acuity (BCVA) at month 6, mean change in the BCVA at month 6; integrity of the perifoveal external limiting membrane and ellipsoid zone on Optical Coherence Tomography (OCT); MH closure rate over time in days; functional improvement of microperimetry Statistical analysis will be performed with Student t-test and the p-value of ≤ 0.05 is considered significant.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A: Conventional ILM peeling
peeling with complete removal of the internal limiting membrane (ILM)
Conventional ILM Peeling
peeling with complete removal of the internal limiting membrane (ILM)
GroupB: Inverted ILM Peeling
the inverted ILM peeling technique, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
Inverted ILM Peeling
the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
Interventions
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Conventional ILM Peeling
peeling with complete removal of the internal limiting membrane (ILM)
Inverted ILM Peeling
the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Any previous treatment for the macular hole
* Evidence on examination of any diabetic retinopathy
* History or presence of wet or dry age macular degeneration (AMD)
* Presence of epiretinal membrane or prior uveitis
* Any ocular surgery within 3 months before baseline
* Intra or periocular infection
18 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Mauricio Maia
Professor of Ophthalmology Dept
Principal Investigators
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Mauricio Maia, MD, PhD
Role: STUDY_DIRECTOR
Federal University of São Paulo
Locations
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Dept. of Ophthalmology
São Paulo, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IMH2019
Identifier Type: -
Identifier Source: org_study_id
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