Photobiomodulation for Dry Age Related Macula Degeneration
NCT ID: NCT05507840
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
121 participants
INTERVENTIONAL
2022-12-01
2027-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intervention
Near or infra red light provided by the Valeda machine will be applied in the intervention eye
Valeda machine
Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
Control
Light with very low intensity provided by the same Valeda machine will be applied in the control eye
Valeda machine
Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
Interventions
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Valeda machine
Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Responsible Party
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ANCA ROALD
Principal Investigator, MD dr. med.
Other Identifiers
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456056
Identifier Type: -
Identifier Source: org_study_id
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