NCT05583253

Brief Summary

Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

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

October 13, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 17, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 13, 2022

Last Update Submit

October 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Changes in visual acuity from baseline and at the 6th month of follow-up measured by snellen chart and converted to logMAR units for statistical analysis.

    Baseline and 6 months after surgery.

Secondary Outcomes (1)

  • Corneal endothelial cells count

    Baseline and 6 months after surgery.

Study Arms (2)

Vitrectomy group with previous refractive surgery

ACTIVE COMPARATOR

Cases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery.

Procedure: Vitrectomy

Vitrectomy group with no previous intraocular surgery

ACTIVE COMPARATOR

Subjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery.

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Small gauge pars-plana vitrectomy for management of retinal detachment.

Also known as: Pars-plana vitrectomy
Vitrectomy group with no previous intraocular surgeryVitrectomy group with previous refractive surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • cases diagnosed with primary retinal detachment and prepared for pars-plana vitrectomy.
  • cases with previous history for refractive surgery were enrolled in refractive surgery group.

You may not qualify if:

  • cases with corneal diseases or trauma that may affect the final visual outcome.
  • cases with other retinal diseases that may affect the final visual outcome as age related macular degenerations and diabetic eye disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University

Banhā, QA, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Retinal DetachmentRefractive Errors

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Marwa A Abdelshafy, MD

    Benha University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Abdelshafy, MD

CONTACT

Marwa Abdelshafy, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON 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

October 13, 2022

First Posted

October 17, 2022

Study Start

October 13, 2022

Primary Completion

June 30, 2023

Study Completion

August 30, 2023

Last Updated

October 17, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations