|
Health Condition(s) or Problem
|
Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology
|
|
Lay Summary
|
Not provided at time of registration (from ISRCTN)
|
|
Who can enter the trial
|
1. Patients of either sex aged 55 years or over
2. Diagnosis of age related maculopathy that meet the criteria of large drusen (=125 µ) in at least 1 eye
3. Best corrected visual acuity in the study eye between 50 to 90 ETDRS letters at baseline visit
4. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
5. No previous macular laser therapy to study eye
6. Written informed consent and willingness and ability to be followed up for 24 months.; Target Gender: Male & Female; Upper Age Limit 90 years ; Lower Age Limit 55 years
|
|
Who cannot enter the trial
|
1. Drusenoid PED, Choroidal neovascularisation and geographic atrophy in the study eye
2. Macular ischaemia (FAZ > 1000µm in diameter or moderate perifoveal capillary loss in fluorescein angiogram) or diabetic retinopathy
3. Macular oedema of any cause such as wet AMD, diabetic macular oedema, pseudophakic macular oedema or taut posterior hyaloid
4. Co-existent ocular disease that in the investigator?s discretion would lead to decrease visual acuity by 3 lines or more by end of 12 months
5. History of thermal lasers or treatment with intravitreal antiVEGF agents or steroids for any retinal conditions
6. Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug including those that has not received regulatory approval at the time of study entry
7. Anticipated major ocular surgery (including cataract extraction) for the period of the trial
8. Amblyopia in study eye
9. Known allergy to fluorescein dye or to any component of the study drug
10. Pregnancy at baseline and the patient will be withdrawn from the study if she becomes pregnant during the course of the study
|
|
What will happen
|
2RT, nano second laser technology 400um spot size at least 25 spots
|
|
Primary aim
|
Visual acuity; Timepoint(s): 1 year
|
|
Secondary Aim
|
Not provided at time of registration
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
Sorry, not currently available
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England
|
|
Location
|
London
|