Retinal regeneration Laser Treatment in Early Age-related Maculopathy
Not Applicable
Recruiting
- Conditions
- Early Age related MaculopathyEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12609001056280
- Lead Sponsor
- Ellex
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in the appearance of drusen in a clinical evaluation.[Clinical evaluation will be conducted at baseline, 1 month, 3 month, 6 month, 9 month, 12 month];An increase in visual functions of the treated eye. Visual functions will be monitored by measuring patients dark adaptation, static test which involves measuring thershold assesments for isoluminant read and blue increments and flicker sensitivity of 4 and 14Hz. Their Photostress cone recovery will also be measured for improvement. 3 questionaires will also be administered[Visual functions will be measured at baseline, 1 month, 3 month, 6 month, 9 month and 12 month. The questionaires will only be administered at baseline and 12 month.]
- Secondary Outcome Measures
Name Time Method nil[nil]