ILM Inverted Flap Size in Macular Hole
- Conditions
- Idiopathic Macular Hole
- Registration Number
- NCT04683276
- Lead Sponsor
- Mansoura University
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Eyes with stage 4 idiopathic MHs with a diameter >250µm on spectral domain optical coherence tomography (SD-OCT)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method rate of macular hole closure 6 months defined as the proportion of the eyes with complete MH closure based on SD-OCT findings
- Secondary Outcome Measures
Name Time Method BCVA 6 months best corrected visual acuity
timing of MH closure 6 months the time of complete macular hole closure
Trial Locations
- Locations (1)
Ophthalmic center
🇪🇬Mansoura, Dakahelia, Egypt
Ophthalmic center🇪🇬Mansoura, Dakahelia, Egypt