Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04278079
• Collaborator: (none)
• Enrollment: 52
• Actual Duration (Months): 61

Study Details

Study Description

Brief Summary

Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting membrane peeling for cases of myopic traction maculopathy

Condition or Disease	Intervention/Treatment	Phase
Myopic Traction Maculopathy; Pars Plana Vitrectomy; Internal Limiting Membrane Peeling	Procedure: Pars Plana Vitrectomy with Internal Limiting Membrane peel	N/A

Detailed Description

Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is the standard of care for patients with myopic traction. A variety of findings are seen by Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes, and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade, in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of the retinal structure by OCT will be examined.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Feb 1, 2020

Outcome Measures

Primary Outcome Measures

1. Improvement of best corrected visual acuity [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Highly myopic patients, having a refractive errors (spherical equivalent) of more than

• 8 Diopter, or an axial length more than 26.5 mm.

• Best Corrected Visual Acuity less than 0.1

• Spectral Domain Optical Coherence Tomography showed; staphylomatous changes, with either: Macular retinoschisis, foveal retinal detachment, full thickness macular hole (with or without macualr hole retinal detachment), or lamellar macular hole, with epiretinal membrane

At least 6 months follow-up

Exclusion Criteria:

• Eyes with diffuse chorioretinal macular atrophy

• Concomitant presence of a choroidal neovascular membrane

• Young patients less than 21 years old.

• History of trauma

• Dense media opacity (corneal/ lenticular)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sharif Yousef El Emam, Clinical Associate Professor, Tanta University
• ClinicalTrials.gov Identifier: NCT04278079
• Other Study ID Numbers: TUORU001
• First Posted: Feb 20, 2020
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia; Macular Degeneration

Study Results

No Results Posted as of Feb 20, 2020