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OpenTrials
Completed

NCT Number: NCT04278079

Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy

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

Completed

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Pars Plana Vitrectomy with Internal Limiting Membrane peel

Procedure

Pars plana vitrectomy with staining and peeling of internal limiting membrane

Primary outcomes

  1. Improvement of best corrected visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Feb 20, 2020
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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