Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for Rhegmatogenous Retinal Detachment

April 4, 2025 updated by: Ehab Mohamed Elsayed Mohamed Saad, Benha University

Outcomes of Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment

Purpose To evaluate the outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications.

Methods This is a prospective randomized controlled trial that included 58 eyes with RRD, divided into Group A (PFCL, n = 29) and Group B (PR, n = 29). Preoperative assessments included best-corrected visual acuity (BCVA), IOP, axial length, lens status, macula status, and PVR grade. Outcomes were evaluated at 1 week, 1 month, 2 months, and 3 months postoperatively. Primary outcomes included retinal reattachment rates and the number of operations; secondary outcomes included BCVA, IOP changes, complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 4450113
        • Ebsar Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

A clear diagnosis of primary RRD requiring surgery, 18 years or older, The potential to return for follow-up visits for at least 6 months post-surgery.

Exclusion criteria:

When presented with tractional or exudative retinal detachment, had surgery on the affected eye in the past, presented with severe eye disorders like advanced glaucoma or endophthalmitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perfluorocarbon Liquid Group
Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
This study compares outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications
Experimental: Posterior Retinotomy Group
Procedure: Perfluorocarbon Liquid vs. Posterior Retinotomy during Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
This study compares outcomes of perfluorocarbon liquid (PFCL) versus posterior retinotomy (PR) during Pars plana vitrectomy (PPV) for Rhegmatogenous retinal detachment (RRD), focusing on anatomical success, visual acuity, intraocular pressure (IOP), and complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal reattachment rates
Time Frame: One month, Two months, and Three Months
One month, Two months, and Three Months
Number of operations
Time Frame: One month, Two months, and Three Monthes
One month, Two months, and Three Monthes

Secondary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity (BCVA)
Time Frame: One month, Two months, and Three Monthes
One month, Two months, and Three Monthes
Intraocular pressure (IOP)
Time Frame: One month, Two months, and Three Monthes
One month, Two months, and Three Monthes
Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success
Time Frame: One month, Two months, and Three Monthes
One month, Two months, and Three Monthes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

July 30, 2024

Study Completion (Actual)

July 30, 2024

Study Registration Dates

First Submitted

March 29, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ophth._20/2024Med.Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rhegmatogenous Retinal Detachment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe