Clinical trial NCT06919211: Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for Rhegmatogenous Retinal Detachment
Official title: Outcomes of Perfluorocarbon Liquid vs. Posterior Retinotomy During Pars-plana Vitrectomy for The Surgical Repair of Rhegmatogenous Retinal Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhegmatogenous Retinal Detachment
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Retinal reattachment rates
timeFrame: One month, Two months, and Three Months
measure: Number of operations
timeFrame: One month, Two months, and Three Monthes
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA)
timeFrame: One month, Two months, and Three Monthes
measure: Intraocular pressure (IOP)
timeFrame: One month, Two months, and Three Monthes
measure: Complications like cataract development, retinal redetachment, epiretinal membrane (ERM) formation, and single-surgery success
timeFrame: One month, Two months, and Three Monthes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebsar Eye Center
Study officials:
References:
citation: 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.
citation: 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.