Peripheral laserphotocoagulation in patients with bilateral drusen
| ISRCTN | ISRCTN96759546 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN96759546 |
| Secondary identifying numbers | OZR-2002-15; NTR192 |
- 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
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
| Study design | Multicentre, randomised, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | Peripheral laserphotocoagulation reduces drusen area in patients with bilateral drusen. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Condition | Bilateral drusen |
| Intervention | Laser photocoagulation peripheral retina. |
| Intervention type | Other |
| Primary outcome measure | 1. Total drusen area 2. Vision (ETDRS) |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2003 |
| Overall study end date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 16 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2003 |
| Recruitment end date | 01/04/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
3011 BH
Netherlands
Sponsor information
Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31 (0)10 401 77 77 |
|---|---|
| info@oogziekenhuis.nl | |
"ROR" |
https://ror.org/02hjc7j46 |
Funders
Funder type
Research organisation
Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)
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 |
