Comparison of Air and Expansile Gas in Pneumatic Retinopexy
2 other identifiers
interventional
126
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 11, 2005
CompletedFirst Posted
Study publicly available on registry
July 18, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 9, 2012
March 1, 2012
July 11, 2005
March 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
1 week
Secondary Outcomes (1)
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
6 weeks
Study Arms (1)
2
ACTIVE COMPARATORair vs perfluoropropane gas in pneumatic retinopexy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Ocular media opacities
- Advanced glaucoma
- Aphakia or pseudophakia
- Previous ocular surgeries
- One-eyed patients
- Subject did not sign informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Khon Kaen Universitylead
- Thailand Research Fundcollaborator
Study Sites (1)
Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002, Thailand
Related Publications (2)
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.
PMID: 20937993RESULTSchwartz 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.
PMID: 32408387DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yosanan Yospaiboon, M.D.
Khon Kaen University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 11, 2005
First Posted
July 18, 2005
Study Start
July 1, 2004
Study Completion
October 1, 2007
Last Updated
March 9, 2012
Record last verified: 2012-03