Air Versus Gas Tamponade in Primary Retinal Detachment

Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05561569

Enrollment

Registered

2022-09-30

Start date

2022-09-26

Completion date

2023-07-01

Last updated

2022-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Vitreoretinopathy, Retinal Detachment

Keywords

Vitrectomy, Retinal detachment

Brief summary

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

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.

Interventions

PROCEDUREPars plana vitrectomy

23 gauge pars plana vitrectomy for managing primary retinal detachment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactAhmed Abdelshafy, MD

ahmad4lg@gmail.com01222328766

Backup ContactMahrous Shaheen, MD

mha13@fayoum.edu.eg0846300587

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026