Trials / Completed
CompletedNCT04683276
ILM Inverted Flap Size in Macular Hole
Impact of the Inverted Internal Limiting Membrane Flap Diameter on Idiopathic Macular Hole Closure: Comparative Randomized Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | pars plana vitrectomy with ILM inverted flap | Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and \>2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper. |
Timeline
- Start date
- 2019-02-01
- Primary completion
- 2020-04-01
- Completion
- 2020-10-01
- First posted
- 2020-12-24
- Last updated
- 2020-12-29
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT04683276. Inclusion in this directory is not an endorsement.