Back to resultsVisual Outcome of Vitrectomy After Refractive Surgery
Primary Purpose
Retinal Detachment, Refractive Errors
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment
Eligibility Criteria
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.
Sites / Locations
- Benha UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vitrectomy group with previous refractive surgery
Vitrectomy group with no previous intraocular surgery
Arm Description
Cases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery.
Subjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Corneal endothelial cells count
Changes in corneal endothelial cells counts measured by specular microscopy in cells/millimeters2 units.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05583253
Brief Title
Visual Outcome of Vitrectomy After Refractive Surgery
Official Title
Visual Outcome of Small Gauge Pars-plana Vitrectomy for Retinal Detachment With Previous Refractive Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Results of retinal detachment surgery may be affected in cases with history of previous intraocular surgery.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Refractive Errors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitrectomy group with previous refractive surgery
Arm Type
Active Comparator
Arm Description
Cases with primary retinal detachment that are prepared for pars-plana vitrectomy with previous history of refractive surgery.
Arm Title
Vitrectomy group with no previous intraocular surgery
Arm Type
Active Comparator
Arm Description
Subjects with primary retinal detachment that are prepared for pars-plana vitrectomy with no previous history of intraocular surgery.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Other Intervention Name(s)
Pars-plana vitrectomy
Intervention Description
Small gauge pars-plana vitrectomy for management of retinal detachment.
Primary Outcome Measure Information:
Title
Visual acuity
Description
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.
Time Frame
Baseline and 6 months after surgery.
Secondary Outcome Measure Information:
Title
Corneal endothelial cells count
Description
Changes in corneal endothelial cells counts measured by specular microscopy in cells/millimeters2 units.
Time Frame
Baseline and 6 months after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Benha University
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy
Phone
01222328766
Email
ahmad4lg@gmail.com
Ext
Abdelshafy
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visual Outcome of Vitrectomy After Refractive Surgery
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