Comparison of Air and Expansile Gas in Pneumatic Retinopexy

March 7, 2012 updated by: Yosanan Yospaiboon, Khon Kaen University
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Khon Kaen, Thailand, 40002
        • Eye outpatients department, Srinagarind Hospital, Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
air vs perfluoropropane gas in pneumatic retinopexy
0.3 ml of filtered air
0.3 ml of perfluoropropane gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Yosanan Yospaiboon, M.D., Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

July 11, 2005

First Submitted That Met QC Criteria

July 11, 2005

First Posted (ESTIMATE)

July 18, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE470116
  • TRF470116 (OTHER_GRANT: Thailand Research Fund)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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