Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Retinal Detachment Clinical Trial

Official title:

Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120445
• Other study ID #: HE470116
• Secondary ID: TRF470116
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2005
• Last updated: March 7, 2012
• Start date: July 2004
• Est. completion date: October 2007

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Procedure:
• air
0.3 ml of filtered air
• expansile gas
0.3 ml of perfluoropropane gas

Locations

Country	Name	City	State
Thailand	Eye outpatients department, Srinagarind Hospital, Khon Kaen University	Khon Kaen

Sponsors (2)

Lead Sponsor	Collaborator
Khon Kaen University	Thailand Research Fund

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. doi: 10.1001/archophthalmol.2010.230. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The retinal reattachment rate (calculated from the number of patients who had post-operative attached retinas divided by the total number of patients treated)		1 week	No
Secondary	The final visual recovery (calculated from the difference between pre-operative and post-operative visual acuity)		6 weeks	No