Clinical trial NCT00120445: Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Official title: Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Retinal Detachment
Keywords: retinal detachment
pneumatic retinopexy
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2005-07-18
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
timeFrame: 1 week
Secondary outcomes:
measure: The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Study officials:
affiliation: Khon Kaen University
name: Yosanan Yospaiboon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.