CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Pars plana vitrectomy with silicone oil +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05377606
NCT05377606N/ACompleted

Macular Perfusion and Sensitivity Following Silicone Oil Tamponade Versus SF6 Gas for Primary Rhegmatogenous Retinal Detachment

Cairo University·interventional·Posted May 17, 2022·Updated Aug 31, 2023

In Brief

A clinical study evaluating Pars plana vitrectomy with silicone oil and Pars plana vitrectomy with SF6 for Rhegmatogenous Retinal Detachment and Primary Vitrectomy. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Rhegmatogenous retinal detachment (RRD) is the separation of the neurosensory retina from the retinal pigment epithelium caused by the presence of a break that leads to the passage of fluid from the vitreous cavity into the potential subretinal space. It is a sight threatening disease, affecting largely people 50 years or older, with an annual incidence varying between 6.3 and 17.9 people per 100,000 population, and is unfortunately increasing. Although other surgical options do exist for the repair of primary RRD, pars plana vitrectomy (PPV) has clear advantages and is certainly effective in the treatment of these patients. Several agents are used for intraocular tamponade following PPV for RRD. These agents are either silicone oil (SO) or gases like air, perfluoropropane (C3F8), sulfur hexafluoride (SF6), or perfluoroethane (C2F6). In addition to the complications uniquely peculiar to using SO, research has found out that a reduction in retinal sensitivity on microperimetry was greater in SO tamponade in comparison with gas, as well as poorer visual outcome, microvasculature damage and affection of retinal layers including ganglion cell complex (GCC) in the SO group. Even though many studies were done to compare between SO and intraocular gas tamponades with respect to many aspects, only one study compared the effects SO had on macular vasculature and anatomy in comparison with air and no study at all to date has compared the SO to SF6 gas in terms of retinal vascular changes, correlating them to thinning of GCC and macular sensitivity, which is precisely the main aim of the current study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMay 17, 2022
Enrollment StartDec 23, 2021
Primary CompletionMar 8, 2023
Study CompletionMay 8, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.1 years ago

Interventions

Pars plana vitrectomy with silicone oilprocedure

Silicone oil will be used at the end of primary vitrectomy. OCT, OCTA and microperimetry will be done 2 months later. Silicone oil will be removed at 3 months. Finally, the OCT, OCTA, and microperimetry will be repeated once more after 4 months from the vitrectomy.

Pars plana vitrectomy with SF6procedure

Sulfur hexafluoride (SF6) will be used at the end of primary vitrectomy. OCT, OCTA, and microperimetry will be done 2 months and 4 months after surgery.