Selective Laser Trabeculoplasty for Primary Angle-Closure Glaucoma: a pilot case study
| ISRCTN | ISRCTN42557387 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42557387 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/05/2006
- Registration date
- 03/07/2006
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Michael Belkin
Scientific
Scientific
Goldschleger Eye Research Institute
Tel Aviv University
Sheba Medical Center
Tel Hashomer
52621
Israel
Study information
| 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 |
| Scientific title | |
| Study acronym | SLT for PACG Study |
| Study objectives | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key exclusion criteria | 1. Secondary causes of angle-closure 2. Corneal abnormalities 3. Advanced glaucomatous optic neuropathy 4. Patient blind in one eye |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 01/07/2006 |
Locations
Countries of recruitment
- Hong Kong
- Israel
- Philippines
- Singapore
- Thailand
Study participating centre
Goldschleger Eye Research Institute
Tel Hashomer
52621
Israel
52621
Israel
Sponsor information
Ellex Medical Pty. Ltd. (Australia)
Industry
Industry
82 Gilbert Street
Adelaide, SA
5000
Australia
| Website | http://www.ellex.com |
|---|
Funders
Funder type
Industry
Ellex Medical Pty Ltd (Australia)
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 |
