Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Pars Plana Vitrectomy Clinical Trial

Official title:

Evaluation of Pars Plana Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04278079
• Other study ID #: TUORU001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Internal Limiting Membrane Peeling
• Myopia
• Myopic Traction Maculopathy
• Pars Plana Vitrectomy

Intervention

Procedure:
• Pars Plana Vitrectomy with Internal Limiting Membrane peel
Pars plana vitrectomy with staining and peeling of internal limiting membrane

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of best corrected visual acuity		6 months