Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SLT for PACG Study
Study hypothesis
To determine whether selective laser trabeculoplasty (SLT) using a Q-switched frequency doubled neodymium-doped yttrium aluminium garnet (Nd:YAG) laser is effective in lowering intraocular pressure in patients with primary angle-closure glaucoma (PACG).
Ethics approval(s)
Ethics approval received from:
1. Singapore Eye Research Institute (SERI-Singapore) (Ref: R424/19/2005) dated 27/10/2005
2. United Christian Hospital (Hong Kong) (Ref: KC/KE05-0073/FR-3) dated on 15/06/2005
Other ethics approval from Chulalongkorn University and Hospital (Thailand), St. Luke's Medical Centre (Philippines) and National University Hospital (Singapore).
Study design
Prospective, observational, uncontrolled, non-comparative study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
Primary angle-closure glaucoma
Intervention
Selective laser trabeculoplasty (SLT)
Intervention type
Other
Primary outcome measure
Intraocular pressure (IOP) at regular intervals of follow-up with the final IOP being measured at six months after the last treatment. Successful outcome defined as greater or equal to 20% reduction in IOP from pre-laser levels.
Secondary outcome measures
IOP measured on other eye if both eyes are eligible for the study.
Overall study start date
01/07/2005
Overall study end date
01/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. PACG
2. Intraocular pressure 21 - 28 mmHg on one or more topical medicine in presence of patent iridotomy
3. At least two months since last iridotomy
4. Aged over 21 years old
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
150
Participant exclusion criteria
1. Secondary causes of angle-closure
2. Corneal abnormalities
3. Advanced glaucomatous optic neuropathy
4. Patient blind in one eye
Recruitment start date
01/07/2005
Recruitment end date
01/07/2006
Locations
Countries of recruitment
Hong Kong, Israel, Philippines, Singapore, Thailand
Study participating centre
Goldschleger Eye Research Institute
Tel Hashomer
52621
Israel
Sponsor information
Organisation
Ellex Medical Pty. Ltd. (Australia)
Sponsor details
82 Gilbert Street
Adelaide
SA
5000
Australia
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Ellex Medical Pty Ltd (Australia)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|