Comparison of Air and Expansile Gas in Pneumatic Retinopexy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00120445

Enrollment

126

Registered

2005-07-18

Start date

2004-07-31

Completion date

2007-10-31

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Detachment

Keywords

retinal detachment, pneumatic retinopexy

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.

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.

Interventions

PROCEDUREair

0.3 ml of filtered air

PROCEDUREexpansile gas

0.3 ml of perfluoropropane gas

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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)	1 week

Secondary

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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026