NCT05561569

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 30, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 26, 2022

Last Update Submit

September 28, 2022

Conditions

Retinal DetachmentProliferative Vitreoretinopathy

Keywords

VitrectomyRetinal detachment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Changes in metamorphopsia

    Change from baseline metamorphopsia at 6th month.

Other Outcomes (1)

  • Recurrence of retinal detachment

    Incidence of recurrent retinal detachment at 6th month.

Study Arms (2)

Air tamponade group

ACTIVE COMPARATOR

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

Procedure: Pars plana vitrectomy

Non expansile gas tamponade group

ACTIVE COMPARATOR

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

Procedure: Pars plana vitrectomy

Interventions

Pars plana vitrectomyPROCEDURE

23 gauge pars plana vitrectomy for managing primary retinal detachment.

Air tamponade groupNon expansile gas tamponade group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdelshafy

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Ahmed A Abdelshafy, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

01222328766ahmad4lg@gmail.com

Mahrous Shaheen, MD

CONTACT

0846300587mha13@fayoum.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Ophthalmology

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 30, 2022

Study Start

September 26, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

September 30, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)