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OpenTrials
Completed

NCT Number: NCT04139811

Evaluation of Visual Functions After Pars Plana Vitrectomy With and Without Internal Limiting Membrane Peeling in RRD

Internal limiting membrane peeling is performed during vitrectomy for macular diseases such as macular holes, macular edema due to diabetic retinopathy and retinal vein occlusion.

The incidence of epiretinal membrane formation after vitrectomy for rhegmatogenous detachment has been reported to range from 4.4% to 12.8%.

In this study, the efficacy and safety of internal limiting membrane peeling will be studied in vitrectomy for rhegmatogenous retinal detachment and if it is essential to peel it in those cases or not.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Age range

20 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Minia UNiversity hospital

Minya, Minya Governorate, 61111, Egypt

About this study

interventional observational study comparing vitrectomy with versus without internal limiting membrane peeling in cases of rhegmatogenous retinal detachment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All eyes with recent macula-off rhegmatogenous retinal detachment (RRD).

Exclusion criteria

  • Complicated cases with advanced proliferative vitreoretinopathy (PVR).
  • Patients with retinal vascular disorders and other macular disorders.
  • Combined tractional and rhegmatogenous detachment.
  • Previous retinal reattachment surgery or Intravitreal injections.
  • Glaucomatous patients.
  • Patients with corneal opacity which impairs good visualization.

Treatment and study plan

Pars Plana Vitrectomy

Other

vitrectomy with and without ILM peeling

Primary outcomes

  1. anatomical outcome

    Time frame: 6 months follow up

    Rate of retinal reattachment using indirect ophthalmoscopy

  2. epiretinal membrane

    Time frame: 6 months follow up

    incidence rate of epiretinal membrane formation after surgery in % percent

Secondary outcomes

  1. functional outcome

    Time frame: 6 months follow up

    visual functions using log Mar Best Corrected Visual Acuity (BCVA)

  2. superficial capillary density

    Time frame: 6 months follow up

    measurement of percent (%) of superficial and deep capillary density using Optical Coherance Tomography Angiography

  3. multi-focal Electroretinogram

    Time frame: 6 months follow up

    measurement of P1 amplitude

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Evaluation of Primary Internal Limiting Membrane Peeling in Cases of Rhegmatogenous Retinal Detachment

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2019
Registry last updated
Oct 25, 2019

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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