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Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011007
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Mahmoud Abouhussein, University of Alexandria

Brief 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.


Condition or disease Intervention/treatment Phase
Macular Holes Retina Detachment Procedure: vitrectomy with or without inverted ILM flap technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Vitrectomy Without Internal Limiting Membrane Peeling Versus Inverted ILM Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: vitrectomy without ILM peeling
vitrectomy without ILM peeling
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.

Active Comparator: vitrectomy with inverted ILM flap technique
vitrectomy with inverted ILM flap technique
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.




Primary Outcome Measures :
  1. visual acuity at one year [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. rate of retinal attachment and macular hole closure. [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: macular hole retinal detachment in high myopic eyes.

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Exclusion Criteria:

  • eyes with previous vitreoretinal surgery, trauma, diabetic retinopathy, retinal vein occlusion, uveitis, and other retinal diseases were excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011007


Locations
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Egypt
Alexandria university
Alexandria, Egypt
Sponsors and Collaborators
University of Alexandria
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Responsible Party: Mahmoud Abouhussein, Assistant professor, University of Alexandria
ClinicalTrials.gov Identifier: NCT04011007    
Other Study ID Numbers: 31241
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Detachment
Retinal Perforations
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases