Visual Outcome of Vitrectomy After Refractive Surgery
Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery
1 other identifier
interventional
50
1 country
1
Brief Summary
Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2022
CompletedStudy Start
First participant enrolled
October 13, 2022
CompletedFirst Posted
Study publicly available on registry
October 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2023
CompletedOctober 17, 2022
October 1, 2022
9 months
October 13, 2022
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 COMPARATORCases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery.
Vitrectomy group with no previous intraocular surgery
ACTIVE COMPARATORSubjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery.
Interventions
Small gauge pars-plana vitrectomy for management of retinal detachment.
Eligibility Criteria
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
- Benha Universitylead
Study Sites (1)
Benha University
Banhā, QA, 13511, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marwa A Abdelshafy, MD
Benha University
Central Study Contacts
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