- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00120445
Comparison of Air and Expansile Gas in Pneumatic Retinopexy
March 7, 2012 updated by: Yosanan Yospaiboon, Khon Kaen University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
126
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Khon Kaen, Thailand, 40002
- Eye outpatients department, Srinagarind Hospital, Khon Kaen University
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
air vs perfluoropropane gas in pneumatic retinopexy
|
0.3 ml of filtered air
0.3 ml of perfluoropropane gas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yosanan Yospaiboon, M.D., Khon Kaen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
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
July 1, 2004
Study Completion (ACTUAL)
October 1, 2007
Study Registration Dates
First Submitted
July 11, 2005
First Submitted That Met QC Criteria
July 11, 2005
First Posted (ESTIMATE)
July 18, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
March 9, 2012
Last Update Submitted That Met QC Criteria
March 7, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE470116
- TRF470116 (OTHER_GRANT: Thailand Research Fund)
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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