Comparison of Air and Expansile Gas in Pneumatic Retinopexy

NCT ID: NCT00120445

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

air vs perfluoropropane gas in pneumatic retinopexy

Group Type ACTIVE_COMPARATOR

air

Intervention Type PROCEDURE

0.3 ml of filtered air

expansile gas

Intervention Type PROCEDURE

0.3 ml of perfluoropropane gas

Interventions

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air

0.3 ml of filtered air

Intervention Type PROCEDURE

expansile gas

0.3 ml of perfluoropropane gas

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thailand Research Fund

OTHER

Sponsor Role collaborator

Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Yosanan Yospaiboon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yosanan Yospaiboon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Eye outpatients department, Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 20937993 (View on PubMed)

Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

Reference Type DERIVED
PMID: 32408387 (View on PubMed)

Other Identifiers

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TRF470116

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HE470116

Identifier Type: -

Identifier Source: org_study_id

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