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
  Purpose

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 Intervention Phase
Retinal Detachment
Procedure: air
Procedure: expansile gas
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 126
Study Start Date: July 2004
Study Completion Date: October 2007
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00120445     History of Changes
Other Study ID Numbers: HE470116, TRF470116
Study First Received: July 11, 2005
Last Updated: March 7, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
retinal detachment
pneumatic retinopexy

Additional relevant MeSH terms:
Retinal Detachment
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on October 21, 2014