Air Versus Gas Tamponade in Primary Retinal Detachment
Primary Purpose
Retinal Detachment, Proliferative Vitreoretinopathy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pars plana vitrectomy
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring Vitrectomy, Retinal detachment
Eligibility Criteria
Inclusion Criteria:
- primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.
Exclusion Criteria:
- cases with combined tractional retinal detachment.
- cases with recurrent retinal detachment.
- cases that are eligible for scleral buckling that have no traction on retinal break.
Sites / Locations
- Ahmed AbdelshafyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Air tamponade group
Non expansile gas tamponade group
Arm Description
Cases with primary upper retinal detachment that will be treated with air tamponade.
Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.
Outcomes
Primary Outcome Measures
Improvement in visual acuity
Visual acuity changes measured by snellen chart and converted to LogMar units.
Secondary Outcome Measures
Changes in metamorphopsia
Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation.
Full Information
NCT ID
NCT05561569
First Posted
September 26, 2022
Last Updated
September 28, 2022
Sponsor
Benha University
1. Study Identification
Unique Protocol Identification Number
NCT05561569
Brief Title
Air Versus Gas Tamponade in Primary Retinal Detachment
Official Title
Randomized Trial Comparing Air Versus Gas Tamponade in Primary Retinal Detachment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 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
Management of primary retinal detachment due to upper retinal break is one of controversial situation that may face ophthalmologists in vitreoretinal subspecialty.
Detailed Description
There is no single surgical plan for management of primary retinal detachment due to upper retinal break, some surgeons prefer scleral buckling over vitrectomy in cases with no traction over the retinal break, others prefer to perform primary pars-plana vitrectomy with either air or gas tamponade.
In this study we aim to compare the results of air and non-expansile gas tamponade in cases with upper retinal detachment with grade a or b proliferative vitreoretinopathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Proliferative Vitreoretinopathy
Keywords
Vitrectomy, Retinal detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Air tamponade group
Arm Type
Active Comparator
Arm Description
Cases with primary upper retinal detachment that will be treated with air tamponade.
Arm Title
Non expansile gas tamponade group
Arm Type
Active Comparator
Arm Description
Cases with primary upper retinal detachment that will be treated with sulfur-hexafluoride 6 (SF-6) gas tamponade.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy
Intervention Description
23 gauge pars plana vitrectomy for managing primary retinal detachment.
Primary Outcome Measure Information:
Title
Improvement in visual acuity
Description
Visual acuity changes measured by snellen chart and converted to LogMar units.
Time Frame
Change from baseline visual acuity at 6th month.
Secondary Outcome Measure Information:
Title
Changes in metamorphopsia
Description
Changes in metamorphopsia after surgery assessed by M-chart that is specially designed to subjectively assess metamorphopsia, each 1 millimeter deviation from reference line is considered significant deviation.
Time Frame
Change from baseline metamorphopsia at 6th month.
Other Pre-specified Outcome Measures:
Title
Recurrence of retinal detachment
Description
Incidence of recurrent retinal detachment in each group assessed by indirect fundus ophthalmoscope.
Time Frame
Incidence of recurrent retinal detachment at 6th month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary rhegmatogenous retinal detachment with upper break with proliferative vitreoretinopathy from grade a to b.
Exclusion Criteria:
cases with combined tractional retinal detachment.
cases with recurrent retinal detachment.
cases that are eligible for scleral buckling that have no traction on retinal break.
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
Mahrous Shaheen, MD
Phone
0846300587
Email
mha13@fayoum.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmed Abdelshafy
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, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Mahrous H Shaheen, MD
Phone
0846300587
Email
mha13@fayoum.edu.eg
First Name & Middle Initial & Last Name & Degree
Mahrous H Shaheen, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Air Versus Gas Tamponade in Primary Retinal Detachment
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