Air Versus Gas Tamponade in Primary Retinal Detachment

Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment

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

Study Overview

• Status: Recruiting
• Conditions: Retinal Detachment; Proliferative Vitreoretinopathy
• Intervention / Treatment: Procedure: Pars plana vitrectomy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Abdelshafy, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com
• Study Contact Backup: Name: Mahrous Shaheen, MD; Phone Number: 0846300587; Email: mha13@fayoum.edu.eg

Study Locations

• Egypt
  • QA
    • Banhā, QA, Egypt, 13511
      • Recruiting
      • Ahmed Abdelshafy
      • Contact: Ahmed Abdelshafy, MD; Phone Number: 01222328766; Email: ahmad4lg@gmail.com
      • Contact: Mahrous H Shaheen, MD; Phone Number: 0846300587; Email: mha13@fayoum.edu.eg
      • Principal Investigator: Mahrous H Shaheen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 28, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Vitrectomy; Retinal detachment
• Additional Relevant MeSH Terms: Mental Disorders; Eye Diseases; Retinal Diseases; Retinal Detachment; Dissociative Disorders; Vitreoretinopathy, Proliferative
• Other Study ID Numbers: Rc.11-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No