Peripheral laserphotocoagulation in patients with bilateral drusen
| ISRCTN | ISRCTN96759546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96759546 |
| Protocol serial number | OZR-2002-15; NTR192 |
| Sponsor | Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands) |
| Funder | Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 05/11/2008
- 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
Dr J C van Meurs
Scientific
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31 (0)10 401 7777 |
|---|---|
| vanMeurs@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Peripheral laserphotocoagulation reduces drusen area in patients with bilateral drusen. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Bilateral drusen |
| Intervention | Laser photocoagulation peripheral retina. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Total drusen area |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 16 |
| Key inclusion criteria | 1. Greater than or equal to 10 drusen (greater than 63 µm) within a 3 mm radius from the fovea 2. Vision less than 0.5 3. No new or previous neovascularisation 4. No sub-retinal pigment epithelium (sub-RPE) serous fluid greater than 1 MPS disc area 5. No geographical atrophy within a radius of 500 µm of the fovea 6. If myopic: less than 8 diopters 7. No previous retinal laser treatment 8. No serious proliferative or non-proliferative diabetic retinopathy of diabetic macula oedema 9. No progressive eye disease 10. Aged greater than or equal to 50 years 11. Bilateral fundus photograph and fluorescein angiography (FAG) of the eye to be treated (less than 2 weeks before treatment) 12. Ability and willingness to participate in 2 year follow-up |
| Key exclusion criteria | 1. Additional laser treatment during follow-up period 2. Vitreous or retina intervention during follow-up 3. Inspection of one of both eye is no longer possible |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
3011 BH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
