Condition category
Eye Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J C van Meurs

ORCID ID

Contact details

Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 7777
vanMeurs@oogziekenhuis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OZR-2002-15; NTR192

Study information

Scientific title

Acronym

Study hypothesis

Peripheral laserphotocoagulation reduces drusen area in patients with bilateral drusen.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Bilateral drusen

Intervention

Laser photocoagulation peripheral retina.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Total drusen area
2. Vision (ETDRS)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

16

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

Trial participating centre

Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands

Sponsor information

Organisation

Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)

Sponsor details

Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
+31 (0)10 401 77 77
info@oogziekenhuis.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes