Condition category
Eye Diseases
Date applied
03/04/2007
Date assigned
13/04/2007
Last edited
11/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sueng-Han Han

ORCID ID

Contact details

Institute of Vision Research
Department of Ophthalmology
Yongdong Severance Hospital
Yonsei University College of Medicine
146-92 Dokok-dong
Kangnam-gu
Seoul
135-720
Korea
South
+82 (0)2 2019 3440
samini@yumc.yonsei.ac.kr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

BS

Study hypothesis

Topical brimonidine administration before strabismus surgery reduced intraoperative bleeding and postoperative subconjunctival haemorrhage in adult patients.

Ethics approval

There was no Institutional Review Board (IRB) at the time of studying. The IRB of our institute was established in 2006, but this study was performed from 2004 to 2005, and our IRB does not approve already completed studies.

All participants understood the procedure exactly and gave informed consent, and the Helsinki declaration and all federal laws were followed.

Study design

Randomised comparative interventional case series

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Strabismus

Intervention

Patients were instilled with either a single drop of brimonidine-purite 0.15%, phenylephrine 1% or sodium hyaluronate 0.1% 15 minutes prior to strabismus surgery.

Intervention type

Drug

Phase

Not Specified

Drug names

Brimonidine, phenylephrine, sodium hyaluronate

Primary outcome measures

Intraoperative bleeding and postoperative subconjunctival haemorrhage were graded on a scale of one to three. Intraoperative bleeding was scored during the surgery, postoperative subconjunctival haemorrhage was graded four hours after surgery.

Secondary outcome measures

Cardiovascular complications and angle-closure glaucoma attack were reported during all follow up periods.

Overall trial start date

10/01/2004

Overall trial end date

04/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients who underwent strabismus surgery under topical anaesthesia.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

Patients who had received prior ocular surgery were excluded.

Recruitment start date

10/01/2004

Recruitment end date

04/05/2007

Locations

Countries of recruitment

Korea, South

Trial participating centre

Institute of Vision Research
Seoul
135-720
Korea, South

Sponsor information

Organisation

Yonsei University College of Medicine (South Korea)

Sponsor details

146-92 Dogok-dong
Kangnam-gu
Seoul
135-720
Korea
South
samini@yumc.yonsei.ac.kr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Yongdong Severance Hospital (South Korea)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17765438

Publication citations

  1. Results

    Hong S, Kim CY, Seong GJ, Han SH, Effect of prophylactic brimonidine instillation on bleeding during strabismus surgery in adults., Am. J. Ophthalmol., 2007, 144, 3, 469-470, doi: 10.1016/j.ajo.2007.04.038.

Additional files

Editorial Notes