Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

NCT ID: NCT04278079

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2020-02-29

Brief Summary

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

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.

Conditions

Myopic Traction Maculopathy; Pars Plana Vitrectomy; Internal Limiting Membrane Peeling

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Pars Plana Vitrectomy with Internal Limiting Membrane peel

Pars plana vitrectomy with staining and peeling of internal limiting membrane

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Sharif Yousef El Emam

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TUORU001

Identifier Type: -

Identifier Source: org_study_id