Air Versus Gas Tamponade in Primary Retinal Detachment

• Sponsor: Benha University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05561569
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 9.1
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment; Proliferative Vitreoretinopathy	Procedure: Pars plana vitrectomy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment
• Actual Study Start Date: Sep 26, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Air tamponade group Cases with primary upper retinal detachment that will be treated with air tamponade.	Procedure: Pars plana vitrectomy; 23 gauge pars plana vitrectomy for managing primary retinal detachment.
Active Comparator: Non expansile gas tamponade group Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.	Procedure: Pars plana vitrectomy; 23 gauge pars plana vitrectomy for managing primary retinal detachment.

Outcome Measures

Primary Outcome Measures

1. Improvement in visual acuity [Change from baseline visual acuity at 6th month.]

   Visual acuity changes measured by snellen chart and converted to LogMar units.

Secondary Outcome Measures

1. Changes in metamorphopsia [Change from baseline metamorphopsia at 6th month.]

   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.

Other Outcome Measures

1. Recurrence of retinal detachment [Incidence of recurrent retinal detachment at 6th month.]

   Incidence of recurrent retinal detachment in each group assessed by indirect fundus ophthalmoscope.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abdelshafy	Banhā	QA	Egypt	13511

Sponsors and Collaborators

• Benha University

Investigators

• Principal Investigator: Ahmed A Abdelshafy, MD, Benha University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
• ClinicalTrials.gov Identifier: NCT05561569
• Other Study ID Numbers: Rc.11-2022
• First Posted: Sep 30, 2022
• Last Update Posted: Sep 30, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University: Vitrectomy; Retinal detachment
• Additional relevant MeSH terms: Retinal Detachment; Vitreoretinopathy, Proliferative; Dissociative Disorders

Study Results

No Results Posted as of Sep 30, 2022