Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- rate of macular hole closure
Study Overview
Brief Summary
In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.
Detailed Description
A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs > 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from >2 to 4DD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)
Exclusion Criteria
- •traumatic MH
- •myopic MHs,
- •MH secondary to retinal detachment,
- •long-standing MH> 12 months
- •previous retinal surgeries
- •high myopia with an axial length > 26.0 mm
- •other ocular pathologies interfering with the interpretation of the OCT reports.
Outcomes
Primary Outcomes
rate of macular hole closure
Time Frame: 6 months
defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
Secondary Outcomes
- BCVA(6 months)
- timing of MH closure(6 months)