Visual Outcome of Vitrectomy After Refractive Surgery

October 13, 2022 updated by: Ahmed Abdelshafy, Benha University

Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • QA
      • Banhā, QA, Egypt, 13511
        • Recruiting
        • Benha University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmed Abdelshafy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 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.
Baseline and 6 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal endothelial cells count
Time Frame: Baseline and 6 months after surgery.
Changes in corneal endothelial cells counts measured by specular microscopy in cells/millimeters2 units.
Baseline and 6 months after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

August 30, 2023

Study Registration Dates

First Submitted

October 13, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rc 12-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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