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

NCT04139811 | Completed DMC

• 1 other identifier: 66-7/2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Detachment

Keywords

Internal limiting membrane; multifocal electoretinogram (ERG); OCT-Angiography

Outcome Measures

Primary Outcomes (2)

• anatomical outcome

  Rate of retinal reattachment using indirect ophthalmoscopy

  6 months follow up

• epiretinal membrane

  incidence rate of epiretinal membrane formation after surgery in % percent

  6 months follow up

Secondary Outcomes (3)

• functional outcome

  6 months follow up

• superficial capillary density

  6 months follow up

• multi-focal Electroretinogram

  6 months follow up

Study Arms (2)

non-ILM peeling group

OTHER

vitrectomy without ILM peeling is done to all cases

Other: Pars Plana Vitrectomy

ILM peeling group

OTHER

vitrectomy with ILM peeling is done to all cases

Other: Pars Plana Vitrectomy

Interventions

Pars Plana Vitrectomy OTHER

vitrectomy with and without ILM peeling

ILM peeling group; non-ILM peeling group

Eligibility Criteria

• Age: 20 Years - 73 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Minia UNiversity hospital

Minya, Minya Governorate, 61111, Egypt

Location

Related Publications (1)

• 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.

  PMID: 32411388 DERIVED

MeSH Terms

Conditions

Retinal Detachment

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Mohamed F Othman, MD

  sub-investigator

  PRINCIPAL INVESTIGATOR

• Ahmed Shawkat, MD

  sub-investigator

  PRINCIPAL INVESTIGATOR

• khalid Murad

  sub-investigator

  PRINCIPAL INVESTIGATOR

• Mohamed Abdullah

  sub-investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of ophthalmology

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 25, 2019
• Study Start: March 15, 2017
• Primary Completion: July 15, 2019
• Study Completion: August 15, 2019
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)