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Visual Outcome of Vitrectomy After Refractive Surgery

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05583253
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
10.5
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vitrectomy
 N/A

Detailed Description

Pars-plana vitrectomy for management of retinal detachment has favorable visual outcome with early intervention and development of small gauge instruments, cases with previous refractive surgery may be affected by other factors that may change the final visual outcome.

In this study, we aim to analyze the effect of refractive surgeries on the final visual outcome after vitrectomy for the management of retinal detachment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery
Actual Study Start Date :
Oct 13, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vitrectomy group with previous refractive surgery

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

Procedure: Vitrectomy
Small gauge pars-plana vitrectomy for management of retinal detachment.
Other Names:
  • Pars-plana vitrectomy

    		•
    Active Comparator: Vitrectomy group with no previous intraocular surgery

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

    Procedure: Vitrectomy
    Small gauge pars-plana vitrectomy for management of retinal detachment.
    Other Names:
  • Pars-plana vitrectomy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [Baseline and 6 months after surgery.]

      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.

    Secondary Outcome Measures

    1. Corneal endothelial cells count [Baseline and 6 months after surgery.]

      Changes in corneal endothelial cells counts measured by specular microscopy in cells/millimeters2 units.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Benha University Banhā QA Egypt 13511

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Study Director: Marwa A Abdelshafy, MD, Benha University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Abdelshafy, Assistant professor of Ophthalmology, Benha University
    ClinicalTrials.gov Identifier:
    NCT05583253
    Other Study ID Numbers:
    • Rc 12-2022
    First Posted:
    Oct 17, 2022
    Last Update Posted:
    Oct 17, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Detachment
    Refractive Errors

    Study Results

    No Results Posted as of Oct 17, 2022