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Comparison of Air and Expansile Gas in Pneumatic Retinopexy

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ClinicalTrials.gov Identifier: NCT00120445
Recruitment Status : Completed
First Posted : July 18, 2005
Last Update Posted : March 9, 2012
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University

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.

Condition or disease Intervention/treatment Phase
Retinal Detachment Procedure: air Procedure: expansile gas Phase 3

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  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Air and Expansile Gas in Pneumatic Retinopexy
Study Start Date : July 2004
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 2
air vs perfluoropropane gas in pneumatic retinopexy
Procedure: air
0.3 ml of filtered air
Procedure: expansile gas
0.3 ml of perfluoropropane gas



Primary Outcome Measures :
  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) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120445


Locations
Thailand
Eye outpatients department, Srinagarind Hospital, Khon Kaen University
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Thailand Research Fund
Investigators
Principal Investigator: Yosanan Yospaiboon, M.D. Khon Kaen University

Publications:
Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00120445     History of Changes
Other Study ID Numbers: HE470116
TRF470116 ( Other Grant/Funding Number: Thailand Research Fund )
First Posted: July 18, 2005    Key Record Dates
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Yosanan Yospaiboon, Khon Kaen University:
retinal detachment
pneumatic retinopexy

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases