Effect of prophylactic Brimonidine instillation on bleeding during Strabismus surgery in adults
| ISRCTN | ISRCTN31792393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31792393 |
| Protocol serial number | 1 |
| Sponsor | Yonsei University College of Medicine (South Korea) |
| Funder | Yongdong Severance Hospital (South Korea) |
- 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
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 |
|---|---|
| samini@yumc.yonsei.ac.kr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised comparative interventional case series |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Brimonidine, phenylephrine, sodium hyaluronate |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Cardiovascular complications and angle-closure glaucoma attack were reported during all follow up periods. |
| Completion date | 04/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
135-720
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
