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Air Versus Gas Tamponade in Primary Retinal Detachment

NCT ID: NCT05561569

Last Updated: 2022-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2023-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Retinal Detachment Proliferative Vitreoretinopathy

Keywords

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Vitrectomy Retinal detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Air tamponade group

Cases with primary upper retinal detachment that will be treated with air tamponade.

Group Type ACTIVE_COMPARATOR

Pars plana vitrectomy

Intervention Type PROCEDURE

23 gauge pars plana vitrectomy for managing primary retinal detachment.

Non expansile gas tamponade group

Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.

Group Type ACTIVE_COMPARATOR

Pars plana vitrectomy

Intervention Type PROCEDURE

23 gauge pars plana vitrectomy for managing primary retinal detachment.

Interventions

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Pars plana vitrectomy

23 gauge pars plana vitrectomy for managing primary retinal detachment.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Abdelshafy

Assistant professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed A Abdelshafy, MD

Role: PRINCIPAL_INVESTIGATOR

Benha University

Locations

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Ahmed Abdelshafy

Banhā, QA, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Abdelshafy, MD

Role: CONTACT

Phone: 01222328766

Email: [email protected]

Mahrous Shaheen, MD

Role: CONTACT

Phone: 0846300587

Email: [email protected]

Facility Contacts

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Ahmed Abdelshafy, MD

Role: primary

Mahrous H Shaheen, MD

Role: backup

Other Identifiers

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Rc.11-2022

Identifier Type: -

Identifier Source: org_study_id