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

NCT ID: NCT06919211

Last Updated: 2025-04-09

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rhegmatogenous Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Perfluorocarbon Liquid Group

Group Type EXPERIMENTAL

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

Intervention Type 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

Posterior Retinotomy Group

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ehab Mohamed Elsayed Mohamed Saad

Lecturer of Ophthalmologyو Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ebsar Eye Center

Cairo, Egypt, Egypt

Site Status

Countries

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Egypt

References

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Vo LV, Ryan EH, Ryan CM, Shah GK, Gupta OP, Capone A Jr, Eliott D, Yonekawa Y, Bhavsar AR, Emerson MV, Jones JM, Emerson GG. Posterior Retinotomy vs Perfluorocarbon Liquid to Aid Drainage of Subretinal Fluid During Primary Rhegmatogenous Retinal Detachment Repair (PRO Study Report No. 10). J Vitreoretin Dis. 2020 Aug 12;4(6):494-498. doi: 10.1177/2474126420941372. eCollection 2020 Nov-Dec.

Reference Type BACKGROUND
PMID: 37007660 (View on PubMed)

Vidne O, Blum Meirovitch S, Rabina G, Abd Eelkader A, Prat D, Barequet D, Moisseiev J, Moisseiev E. Perfluorocarbon Liquid Vs. Subretinal Fluid Drainage during Vitrectomy for the Primary Repair of Rhegmatogenous Retinal Detachment: A Comparative Study. Curr Eye Res. 2018 Nov;43(11):1389-1394. doi: 10.1080/02713683.2018.1490436. Epub 2018 Jul 9.

Reference Type BACKGROUND
PMID: 29912572 (View on PubMed)

Mohamed Elsayed Saad E, Elbadry Mohammed Mohammed H, Mohamed-Aly Ibrahim M, Hassan Salama Selim O, Mostafa Elsayed Abdelhafeez S, Mohammed Sakr A, Mohamed Abo Elftouh Elsalhy F, Abdelmohsen Ali Ayoub A, Abdelsamea Alazab E, Tharwat E, Gamal El Sayed Mostafa T. Outcomes of perfluorocarbon liquid vs. posterior retinotomy as adjuncts during pars-plana vitrectomy for the surgical repair of rhegmatogenous retinal detachment: a randomized clinical trial. BMC Ophthalmol. 2025 Aug 19;25(1):476. doi: 10.1186/s12886-025-04271-w.

Reference Type DERIVED
PMID: 40830767 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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Ophth._20/2024Med.Research

Identifier Type: -

Identifier Source: org_study_id

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