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OpenTrials
Completed

NCT Number: NCT06919211

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

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Key information

Conditions

Rhegmatogenous Retinal Detachment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ebsar Eye Center

Cairo, Egypt, 4450113

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Procedure

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

Primary outcomes

  1. Retinal reattachment rates

    Time frame: One month, Two months, and Three Months

  2. Number of operations

    Time frame: One month, Two months, and Three Monthes

Secondary outcomes

  1. Best-corrected visual acuity (BCVA)

    Time frame: One month, Two months, and Three Monthes

  2. Intraocular pressure (IOP)

    Time frame: One month, Two months, and Three Monthes

  3. Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success

    Time frame: One month, Two months, and Three Monthes

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

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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