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

NCT ID: NCT04139811

Last Updated: 2019-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2019-08-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinal Detachment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

non-ILM peeling group

vitrectomy without ILM peeling is done to all cases

Group Type OTHER

Pars Plana Vitrectomy

Intervention Type OTHER

vitrectomy with and without ILM peeling

ILM peeling group

vitrectomy with ILM peeling is done to all cases

Group Type OTHER

Pars Plana Vitrectomy

Intervention Type OTHER

vitrectomy with and without ILM peeling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pars Plana Vitrectomy

vitrectomy with and without ILM peeling

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

73 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Minia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hossam Mohamed Moharram

Assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mohamed F Othman, MD

Role: PRINCIPAL_INVESTIGATOR

sub-investigator

Ahmed Shawkat, MD

Role: PRINCIPAL_INVESTIGATOR

sub-investigator

khalid Murad

Role: PRINCIPAL_INVESTIGATOR

sub-investigator

Mohamed Abdullah

Role: PRINCIPAL_INVESTIGATOR

sub-investigator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Minia UNiversity hospital

Minya, Minya Governorate, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 32411388 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

66-7/2018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

1ry Versus 2ry ILM Peeling in RD
NCT07346560 RECRUITING NA