Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
Randomized Clinical Trials to Compare the Healing Process of Idiopathic Macular Hole With Different Surgical Techniques
1 other identifier
interventional
60
1 country
1
Brief Summary
To compare anatomic and functional results, and to evaluate postoperatively the healing process in 2 different techniques for the closure of the macular holes (MH)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2018
CompletedFirst Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMarch 25, 2019
March 1, 2019
2 years
March 21, 2019
March 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Anatomic closure
Rate of anatomic macular hole closure in the OCT at month 6
Month 6 post operative
Secondary Outcomes (3)
BCVA mean
Month 6 post operative
BCVA change
Screening and Month 6 post operative
Integrity Membrane measured in microns (μm) by OCT
Month 6 post operative
Study Arms (2)
Group A: Conventional ILM peeling
ACTIVE COMPARATORpeeling with complete removal of the internal limiting membrane (ILM)
GroupB: Inverted ILM Peeling
ACTIVE COMPARATORthe 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
Interventions
peeling with complete removal of the internal limiting membrane (ILM)
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
You may qualify if:
- \> Stage 3 and 4 macular holes with visual acuity between 20/30 and 20/800 according to the ETDRS chart.
You may not qualify if:
- Macular holes secondary to ocular trauma, myopia or retinal detachment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Ophthalmology
São Paulo, 04023-062, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mauricio Maia, MD, PhD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Ophthalmology Dept
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
June 15, 2018
Primary Completion
June 15, 2020
Study Completion
June 30, 2020
Last Updated
March 25, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share