Macular Holes Clinical Trial
Official title:
Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
NCT number | NCT04011007 |
Other study ID # | 31241 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | June 1, 2019 |
Verified date | July 2019 |
Source | University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to determine whether inverted ILM peeling technique could
contribute to high reattachment and closure rates after vitrectomy in patients with myopic
macular hole retinal detachment (MHRD) in comparison to no ILM peeling.
This retrospective study will include 40 patients presenting by myopic macular hole retinal
detachment. Exclusion criteria will include history of trauma, choroidal neovascularization,
and the presence of a peripheral retinal break or proliferative vitreoretinopathy before the
initial surgery.
Subjects will be divided into 2 groups; Group 1 will include 20 patients that were treated by
vitrectomy without ILM peeling and postoperative gas or silicone oil tamponade with or
without cataract surgery.
Group 2 will include 20 patients that were treated by vitrectomy with ILMflap technique and
postoperative gas or silicone oil tamponade with or without cataract surgery.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 1, 2019 |
Est. primary completion date | January 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: macular hole retinal detachment in high myopic eyes. - Exclusion Criteria: - eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria university | Alexandria |
Lead Sponsor | Collaborator |
---|---|
University of Alexandria |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | visual acuity at one year | 12 months | ||
Secondary | rate of retinal attachment and macular hole closure. | 12 months |
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