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Comparison of Air and Expansile Gas in Pneumatic Retinopexy

This study has been completed.
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00120445
First received: July 11, 2005
Last updated: March 7, 2012
Last verified: March 2012

July 11, 2005
March 7, 2012
July 2004
Not Provided
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 ] [ Designated as safety issue: No ]
The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)
Complete list of historical versions of study NCT00120445 on ClinicalTrials.gov Archive Site
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Not Provided
Not Provided
 
Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Comparison of Air and Expansile Gas in Pneumatic Retinopexy

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Retinal Detachment
  • Procedure: air
    0.3 ml of filtered air
  • Procedure: expansile gas
    0.3 ml of perfluoropropane gas
Active Comparator: 2
air vs perfluoropropane gas in pneumatic retinopexy
Interventions:
  • Procedure: air
  • Procedure: expansile gas
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
October 2007
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00120445
HE470116, TRF470116
Yes
Yosanan Yospaiboon, Khon Kaen University
Khon Kaen University
Thailand Research Fund
Principal Investigator: Yosanan Yospaiboon, M.D. Khon Kaen University
Khon Kaen University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP