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

NCT06919211 | Completed

• 1 other identifier: Ophth._20/2024Med.Research
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhegmatogenous Retinal Detachment

Outcome Measures

Primary Outcomes (2)

• Retinal reattachment rates

  One month, Two months, and Three Months

• Number of operations

  One month, Two months, and Three Monthes

Secondary Outcomes (3)

• Best-corrected visual acuity (BCVA)

  One month, Two months, and Three Monthes

• Intraocular pressure (IOP)

  One month, Two months, and Three Monthes

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

  One month, Two months, and Three Monthes

Study Arms (2)

Perfluorocarbon Liquid Group

EXPERIMENTAL

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

Posterior Retinotomy Group

EXPERIMENTAL

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

Interventions

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

Perfluorocarbon Liquid Group; Posterior Retinotomy Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Ebsar Eye Center

Cairo, Egypt, 4450113, Egypt

Location

Related Publications (3)

• 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.

  PMID: 37007660 BACKGROUND

• 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.

  PMID: 29912572 BACKGROUND

• 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.

  PMID: 40830767 DERIVED

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Ophthalmologyو Department of Ophthalmology, Faculty of Medicine, Benha University, Egypt

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 9, 2025
• Study Start: January 15, 2024
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: April 9, 2025

Record last verified: 2025-03

Locations

EG (1)