Photobiomodulation for Dry Age Related Macula Degeneration
Not Applicable
Not yet recruiting
- Conditions
- PhotobiomodulationAge-Related Macular Degeneration
- Interventions
- Device: Valeda machine
- Registration Number
- NCT05507840
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 121
Inclusion Criteria
- patients with dry AMD in the study eye and wet AMD in the control eye
Exclusion Criteria
- Geographic atrophy of the central macular region at enrolment
- Previous/ active wet AMD in the study eye
- A history of epilepsy
- Retinal diseases apart from AMD
- Significant media opacities
- Cataracts worse than grade 2 (LOCS III classification)
- Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
- Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
- Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
- Unable to give informed consent
- Unable to cooperate with the treatment and follow-up
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Valeda machine Near or infra red light provided by the Valeda machine will be applied in the intervention eye Control Valeda machine Light with very low intensity provided by the same Valeda machine will be applied in the control eye
- Primary Outcome Measures
Name Time Method Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up 3 years
- Secondary Outcome Measures
Name Time Method