Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Primary Purpose
Retinal Detachment
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
air
expansile gas
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring retinal detachment, pneumatic retinopexy
Eligibility Criteria
Inclusion Criteria: Superior retinal break from 8 o'clock to 4 o'clock Single retinal break not greater than 2.5 clock hours in size Multiple breaks not greater than 3 clock hours away No (or minimal) proliferative vitreoretinopathy Physically and mentally co-operated in post-operative head positioning Signed informed consent form for the study Exclusion Criteria: Ocular media opacities Advanced glaucoma Aphakia or pseudophakia Previous ocular surgeries One-eyed patients Subject did not sign informed consent form
Sites / Locations
- Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
2
Arm Description
air vs perfluoropropane gas in pneumatic retinopexy
Outcomes
Primary Outcome Measures
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
Secondary Outcome Measures
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Full Information
NCT ID
NCT00120445
First Posted
July 11, 2005
Last Updated
March 7, 2012
Sponsor
Khon Kaen University
Collaborators
Thailand Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT00120445
Brief Title
Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Official Title
Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
Collaborators
Thailand Research Fund
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of the study is to evaluate the results of using air versus expansile gas (perfluoropropane) in the treatment of rhegmatogenous retinal detachment by pneumatic retinopexy, comparing the retinal reattachment rate and post-operative visual recovery.
Detailed Description
To the best of the investigators' knowledge there have been no clinical trials to compare air and expansile gas in pneumatic retinopexy. The investigators hypothesize that both air and expansile gas have the same properties of gas and remain in the eye for 5-6 days which is long enough to have moderate chorioretinal adhesion to seal the retinal break. If the investigators can prove that air is equivalent to expansile gas in this procedure, it can save a lot of money for the country. Therefore, the investigators are conducting a randomised controlled double-blind study to compare the results of using air and perfluoropropane in pneumatic retinopexy for treatment of rhegmatogenous retinal detachment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
Keywords
retinal detachment, pneumatic retinopexy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
air vs perfluoropropane gas in pneumatic retinopexy
Intervention Type
Procedure
Intervention Name(s)
air
Intervention Description
0.3 ml of filtered air
Intervention Type
Procedure
Intervention Name(s)
expansile gas
Intervention Description
0.3 ml of perfluoropropane gas
Primary Outcome Measure Information:
Title
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Superior retinal break from 8 o'clock to 4 o'clock
Single retinal break not greater than 2.5 clock hours in size
Multiple breaks not greater than 3 clock hours away
No (or minimal) proliferative vitreoretinopathy
Physically and mentally co-operated in post-operative head positioning
Signed informed consent form for the study
Exclusion Criteria:
Ocular media opacities
Advanced glaucoma
Aphakia or pseudophakia
Previous ocular surgeries
One-eyed patients
Subject did not sign informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosanan Yospaiboon, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye outpatients department, Srinagarind Hospital, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20937993
Citation
Sinawat S, Ratanapakorn T, Sanguansak T, Prompol S, Laopaiboon M, Yospaiboon Y. Air vs perfluoropropane gas in pneumatic retinopexy: a randomized noninferiority trial. Arch Ophthalmol. 2010 Oct;128(10):1243-7. doi: 10.1001/archophthalmol.2010.230.
Results Reference
result
PubMed Identifier
32408387
Citation
Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Results Reference
derived
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Comparison of Air and Expansile Gas in Pneumatic Retinopexy
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