None listed
Conditions
Brief summary
This is a clinical research study to trial a new laser treatment with the aim of slowing or partially reversing the progression Age Related Macular Degeneration (AMD), a disease which affects the retina and can ultimately lead to central vision blindness. Curently there is no treatment available for Early AMD. The study device is a laser which has been specially developed to treat retinal diseases and in this setting it is hoped it will target cells involved in the disease process and exhibit a wound healing effect which may lead to a delay or halt in the progression of AMD. The results of the laser will be monitored by asessing clinical markers and measuring visual functions.
Interventions
The intervention involves the use of a new laser called the 2RT retinal Regeneration Therapy laser. The laser will be applied once only to one eye. It will be fired approximately 12 times near the arcades of the retina. It utilises low energy and extremely short nanosecond duration laser to produce very limited effects.
Sponsors
Ellex
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
45 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Bliateral multiple large drusen( >125 micron) and pigment changes. Impaired dark adaptation in both eyes. Vison equal to or better than 6/19.
Exclusion criteria
Advanced AMD. Diabetic retinopathy. Glaucomous changes. Pathology which significantly compromises therapeutic or investigative access to the fundus fo the eye. Intraocular surgery other than uncomplicated cataract surgery > 6 months. History or evidence of previous retinal disorder or retinal laser treatment or intra-ocular inflammotory disease. Other retianl or ocular disease or recent symptoms of wet AMD. Known allergic hypersensitivity to fluorescein. Active malignant diseases or other serious systemic diseases.
Outcome results
None listed