Diffuse laser treatment for prophylaxis of the fellow eye with age-related maculopathy in patients with exudative age-related macular degeneration (AMD)
| ISRCTN | ISRCTN74548520 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74548520 |
| Secondary identifying numbers | N0116169807 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 15/04/2016
- 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
Mr NHV Chong
Scientific
Scientific
Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom
| Phone | +44 020 7737 4548 |
|---|---|
| victor@eretina.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Diffuse laser treatment for prophylaxis of the fellow eye with age-related maculopathy in patients with exudative age-related macular degeneration (AMD) |
| Study objectives | Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The formation of abnormal blood vessels (Choroidal Neovascular Vessels = CNV) under the retina is the main cause of visual loss. It is often referred to as 'wet' AMD. Once the first eye is affected, the other eye has a high risk of developing the disease. This risk is increased (>70% in 5 years) if the fellow eye has signs of early disease in the form of yellow deposits known as drusen. Drusen disappear in over 60% of eyes treated with focal laser treatment. However, this type of laser can cause focal damage to the eye leading to a slight increase risk of developing CNV. Nonetheless, those who do not develop this complication, have better vision. We propose to use diffuse laser treatment to make drusen disappear, in which laser energy is transmitted to a larger area of the retina. As the laser energy is applied diffusely, it is unlikely to cause focal damage and hence it is possible that this can reduce the risk of developing CNV. Diffuse laser is has previously been used as a treatment for wet AMD, and it has been shown to be a safe procedure. The aim of this study is to evaluate whether diffuse laser treatment reduce the rate of CNV development in the fellow eye of patients with wet AMD and hence maintain stable vision. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Eye Diseases: Age-related macular degeneration (AMD) |
| Intervention | Age-related macular degeneration (AMD) is one of the leading causes of blindness in the western world. Currently there is no cure for this disease and treatment options for stabilising the vision are limited and expensive. AMD can be identified in its early stages by the appearance of pigment changes and yellow deposits (drusen) which form in the macular. At this stage the patient usually has minimal symptoms. There is however a high risk of CNV formation which is the blinding condition. We would like to enrol patients at the early stage of the disease to see if our proposed treatment will reduce their risk of converting to CNV. Eligible patients will be referred to the principle investigator for the project who will explain the aims and limitations of the study including the background data, study design and relevant risks and benefits. Written informed consent will be obtained and a patient information leaflet including contact numbers will be given to the patient. A letter explaining the details and enrolment into the trial will be sent to the GP. Patients will be asked to attend the outpatient clinic on day 1 (baseline) with follow up at 6 monthly intervals for the first year and yearly for the second year. The baseline visit will include documentation of visual acuity, complete ocular examination, colour fundus photography, taking a single serum sample for analysis followed by randomisation to either diffuse laser treatment or placebo treatment of the fellow eye. The diffuse laser treatment or placebo will involve instillation of topical anaesthetic drops followed by placing a laser contact lens on the eye to be treated. A diode laser using 3000 micron spot size at 400mW (active treatment) or 0mW (placebo) is applied for 60 seconds centred on the fovea. No after care is required. Follow up appointments will be carried out by a masked observer with repeat documentation of the visual acuity, colour fundus photography. Repeat serum sample is taken at exit from the trial. All visual symptoms are documented and a complete dilated ocular examination will be performed. The rate of conversion to CNV will be documented and confirmed using fundus fluoresceine angiogram. |
| Intervention type | Other |
| Primary outcome measure | Rate of development of CNV |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2005 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Outpatients aged 55 or over with a diagnosis of exudative age-related macular degeneration in one eye and early changes of AMD (drusen and retinal pigment changes) in the other eye |
| Key exclusion criteria | 1. Patients in whom colour fundus photography is not possible due to ocular media opacities or other disabilities 2. Those with other retinal diseases. |
| Date of first enrolment | 01/07/2005 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Kings College Hospital NHS Trust R&D Consortium
No information available
Own Account
No information available
NHS R&D Support Funding
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 |
Editorial Notes
Editorial Notes
15/04/2016: No publications found, verifying study status with principal investigator.
