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Completed

NCT Number: NCT00120445

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eye outpatients department, Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

air

Procedure

0.3 ml of filtered air

expansile gas

Procedure

0.3 ml of perfluoropropane gas

Primary outcomes

  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 outcomes

  1. The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • Thailand Research Fund

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Jul 18, 2005
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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