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CompletedNCT04139811Updated Oct 25, 2019

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

An interventional study of Pars Plana Vitrectomy in Retinal Detachment, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 73 Years. Per ClinicalTrials.gov, last updated 2019-10-25.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Mar 2017, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 73 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Retinal Detachment

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Keywords

  • Internal limiting membrane
  • multifocal electoretinogram (ERG)
  • OCT-Angiography
03

In context

Retinal Detachment

207 studies on the registry are indexed under Retinal Detachment; 27 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 136 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

Minia University is the lead sponsor of 356 studies on the registry; 115 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 73 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Other
    non-ILM peeling group

    vitrectomy without ILM peeling is done to all cases

    Other: Pars Plana Vitrectomy

  • Other
    ILM peeling group

    vitrectomy with ILM peeling is done to all cases

    Other: Pars Plana Vitrectomy

Interventions

  • OtherPars Plana Vitrectomy

    vitrectomy with and without ILM peeling

06

What researchers measure

Primary outcomes

  1. anatomical outcome

    Rate of retinal reattachment using indirect ophthalmoscopy

    Time frame: 6 months follow up

  2. epiretinal membrane

    incidence rate of epiretinal membrane formation after surgery in % percent

    Time frame: 6 months follow up

Secondary outcomes

  1. functional outcome

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

    Time frame: 6 months follow up

  2. superficial capillary density

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

    Time frame: 6 months follow up

  3. multi-focal Electroretinogram

    measurement of P1 amplitude

    Time frame: 6 months follow up

07

Study locations

1 site
  • Minia UNiversity hospital
    Minya, Minia 61111, Egypt
08

References and documents

Publications

  • Abdullah ME, Moharram HEM, Abdelhalim AS, Mourad KM, Abdelkader MF. Evaluation of primary internal limiting membrane peeling in cases with rhegmatogenous retinal detachment. Int J Retina Vitreous. 2020 May 7;6:8. doi: 10.1186/s40942-020-00213-4. eCollection 2020. PubMed 32411388 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04139811
Lead sponsor
Minia University
Responsible party
Hossam Mohamed Moharram (Assistant professor of ophthalmology, Minia University) — Principal investigator
First posted
Oct 25, 2019
Start date
Mar 15, 2017
Primary completion
Jul 15, 2019
Completion
Aug 15, 2019
Last update
Oct 25, 2019

Study contacts

Mohamed F Othman, MD
principal investigator · sub-investigator
Ahmed Shawkat, MD
principal investigator · sub-investigator
khalid Murad
principal investigator · sub-investigator
Mohamed Abdullah
principal investigator · sub-investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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