Is repeated laser treatment effective in intraocular pressure (IOP) reduction?
| ISRCTN | ISRCTN67927615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67927615 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/01/2010
- Registration date
- 16/03/2010
- Last edited
- 04/10/2011
- 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
Dr Marcelo Ayala
Scientific
Scientific
Glaucoma Department
Klinik 3
St Eriks Eye Hospital
Polhemsgatan 50
Stockholm
112 82
Sweden
| Phone | +46 (0)8 6723507 |
|---|---|
| marcelo.ayala@sankterik.se |
Study information
| Study design | Single centre prospective randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet (in Swedish) |
| Scientific title | Intraocular pressure reduction after repeated selective laser trabeculoplasty (SLT): A prospective randomised clinical trial |
| Study objectives | Is repeated laser treatment as effective as non-repeated treatment in decreasing IOP? Glaucoma is a progressive neuropathy localised in the optic nerve that may lead to blindness. Reducing IOP seems to be the only treatment to stop progression in glaucoma. There are several methods to reduce IOP: medical treatment, laser and surgery. |
| Ethics approval(s) | Local ethics committee of the Karolinska Institutet approved on the 28th of January 2009 (ref: 2009/ 1:1) |
| Health condition(s) or problem(s) studied | Glaucoma |
| Intervention | Patients will be treated with SLT 2 and randomly divided to treatment in adjacent place (classically treated) or in the same place. Then will be checked at 1 month, 3 months, 6 months and 12 months after SLT 2. |
| Intervention type | Other |
| Primary outcome measure | IOP after repeated SLT in the same area against repeated SLT treatment in adjacent areas. IOP will be measured with the Goldmann applanation tonometry (GAT) at base line (before treatment) and then 1, 3, 6 and 12 months after treatment. |
| Secondary outcome measures | 1. Genders influence on IOP 2. Ages influence on IOP 3. Pseudoexfoliations influence on IOP 4. Inflammation measurements using a slit-lamp and according to the international classification of the Standardization of Uveitis Nomenclature (SUN) Working Group |
| Overall study start date | 01/02/2010 |
| Completion date | 01/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Patients suffering from glaucoma or Ocular Hypertenstion (OHT) 1.1. Primary open angle glaucoma (POAG) - open angle defined as > grade II (Shaffer classification: scale 0-IV) assessed by gonioscopy 1.2. Pigmentary and pseudoexfoliative glaucoma 1.3. OHT to be treated with SLT 2 both with and without eye-drops. 2. If both eyes must be treated just one will be selected at random. 3. Older than 18 years, no upper age limit 4. Men and women |
| Key exclusion criteria | 1. Patients treated with cortisone or immunosuppressive drugs 2. Patients suffering from ocular or systemic inflammatory diseases 3. Patients with Possner-Schlossman syndrome 4. Patients that cannot be treated with SLT due to eyes characteristics (shallow anterior chamber) or bad collaboration |
| Date of first enrolment | 01/02/2010 |
| Date of final enrolment | 01/12/2010 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Glaucoma Department
Stockholm
112 82
Sweden
112 82
Sweden
Sponsor information
St Eriks Eye Hospital (Sweden)
Hospital/treatment centre
Hospital/treatment centre
Glaucoma Department
St Eriks Eye Hospital
Polhemsgatan 50
Stockholm
112 82
Sweden
| Phone | +46 (0)8-6723507 |
|---|---|
| marcelo.ayala@sankterik.se | |
"ROR" |
https://ror.org/03z5b5h37 |
Funders
Funder type
Charity
Karolinska Institute Research Foundation (Sweden)
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 |
