Air Versus Gas Tamponade in Primary Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05561569
• Other study ID #: Rc.11-2022
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2022
• Source: Benha University
• Contact: Ahmed Abdelshafy, MD
• Phone: 01222328766
• Email: ahmad4lg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.

Description:

There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.

In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.

Exclusion Criteria:

• cases with combined tractional retinal detachment.

• cases with recurrent retinal detachment.

• cases that are eligible for scleral buckling that have no traction on retinal break.

Related Conditions & MeSH terms

• Dissociative Disorders
• Proliferative Vitreoretinopathy
• Retinal Detachment

Intervention

Procedure:
• Pars plana vitrectomy
23 gauge pars plana vitrectomy for managing primary retinal detachment.

Locations

Country	Name	City	State
Egypt	Ahmed Abdelshafy	Banha	QA

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recurrence of retinal detachment	Incidence of recurrent retinal detachment in each group assessed by indirect fundus ophthalmoscope.	Incidence of recurrent retinal detachment at 6th month.
Primary	Improvement in visual acuity	Visual acuity changes measured by snellen chart and converted to LogMar units.	Change from baseline visual acuity at 6th month.
Secondary	Changes in metamorphopsia	Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation.	Change from baseline metamorphopsia at 6th month.