Effect of prophylactic Brimonidine instillation on bleeding during Strabismus surgery in adults

ISRCTN	ISRCTN31792393
DOI	https://doi.org/10.1186/ISRCTN31792393
Secondary identifying numbers	1

Submission date: 03/04/2007
Registration date: 13/04/2007
Last edited: 11/08/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Sueng-Han Han
Scientific

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

Phone	+82 (0)2 2019 3440
Email	samini@yumc.yonsei.ac.kr

Study information

Study design	Randomised comparative interventional case series
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	BS
Study objectives	Topical brimonidine administration before strabismus surgery reduced intraoperative bleeding and postoperative subconjunctival haemorrhage in adult patients.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Brimonidine, phenylephrine, sodium hyaluronate
Primary outcome measure	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 study start date	10/01/2004
Completion date	04/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	90
Key inclusion criteria	Adult patients who underwent strabismus surgery under topical anaesthesia.
Key exclusion criteria	Patients who had received prior ocular surgery were excluded.
Date of first enrolment	10/01/2004
Date of final enrolment	04/05/2007

Locations

Countries of recruitment

Korea, South

Study participating centre

Institute of Vision Research

Seoul
135-720
Korea, South

Sponsor information

Yonsei University College of Medicine (South Korea)
Hospital/treatment centre

146-92 Dogok-dong
Kangnam-gu
Seoul
135-720
Korea, South

Email	samini@yumc.yonsei.ac.kr
"ROR"	https://ror.org/01wjejq96

Funders

Funder type

Hospital/treatment centre

Yongdong Severance Hospital (South Korea)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2007		Yes	No