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van CCT (UK)


Peripheral laserphotocoagulation in patients with bilateral drusen.


- candidate number0
- NTR NumberNTR192
- ISRCTNISRCTN96759546
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR23-aug-2005
- Secondary IDsOZR-2002-15 
- Public TitlePeripheral laserphotocoagulation in patients with bilateral drusen.
- Scientific TitlePeripheral laserphotocoagulation in patients with bilateral drusen.
- ACRONYMN/A
- hypothesisPeripheral laserphotocoagulation reduces drusen area in patients with bilateral drusen.
- Healt Condition(s) or Problem(s) studiedBilateral drusen
- Inclusion criteria1. >= 10 drusen (> 63 ým) within a 3 mm radius from the fovea;
2. Vision < 0.5;
3. No new or previous neovascularization;
4. No sub-RPE serous fluid > 1 MPS disc area;
5. No geographical atrophy within a radius of 500 ým of the fovea;
6. If myopic: < 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. Age >= 50 years;
11. Bilateral fundus photograph and FAG of the eye to be treated (< 2 weeks before treatment);
12. Ability and willingness to participate in 2 year follow-up.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2003
- planned closingdate1-apr-2005
- Target number of participants16
- InterventionsLaser photocoagulation peripheral retina.
- Primary outcome1. Total drusen area;
2. Vision (ETDRS).
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator Oogziekenhuis Rotterdam (OZR)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek het Oogziekenhuis
- PublicationsN/A
- Brief summaryRemark: Control = untreated eye. N/A
- Main changes (audit trail)
- RECORD6-sep-2005 - 12-sep-2014


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