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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2019
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design


Intervention

Procedure:
vitrectomy with or without inverted ILM flap technique
vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

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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