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Air Versus Gas Tamponade in Primary Retinal Detachment

B

Benha University

Status

Enrolling

Conditions

Proliferative Vitreoretinopathy
Retinal Detachment

Treatments

Procedure: Pars plana vitrectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05561569
Rc.11-2022

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Air tamponade group
Active Comparator group
Description:
Cases with primary upper retinal detachment that will be treated with air tamponade.
Treatment:
Procedure: Pars plana vitrectomy
Non expansile gas tamponade group
Active Comparator group
Description:
Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.
Treatment:
Procedure: Pars plana vitrectomy

Trial contacts and locations

1

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Central trial contact

Mahrous Shaheen, MD; Ahmed Abdelshafy, MD

Data sourced from clinicaltrials.gov

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