avigated Thermal Laser Therapy of the Macula in Intermediate Age-related Macular Degeneratio
- Conditions
- Age-related Macular Degeneration (AMD)
- Registration Number
- DRKS00031781
- Lead Sponsor
- Medizinische Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
• clinically diagnosed early or intermediate AMD with soft drusen, reticular pseudodrusen or both
• BCVA between 20/25 and 20/200
• clear optical media
• ability to communicate and understand the essence of the study
• ability to give written consent
• advanced AMD, neovascular AMD, geographic atrophy or intraretinal hyperreflective foci (migrating-RPE) in the treated eye, incomplete outer retinal atrophy (iRORA)
• any prior treatment, except for antioxidants, vitamins or other supplements
• opacity of optic media like Cataract, corneal haze, vitreous haze and the need for cataract-surgery within the next 12 months on physicians descretion
• glaucoma (advanced or untreated)
• any other eye disease that may advance during the trial and lead to vision loss
• uveitis
• any medication known to be toxic to the eye
• operations to the eye up to three months prior to the study
• any prior thermal laser therapy to the macula
• vitrectomy, filter operation, corneal transplantation retinal detachment in medical history
• therapeutic irradiation of the eye prior to the study
• neurological diseases that might impair functional and electrophysiological results
• pregnancy should not affect the included women, since age is above 55.
• participation in other clinical trial within the trial or 6 months prior
• severe medical condition making the trial impossible
• upon physicians judgement
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual function assessment:<br>low contrast visual acuity (LCVA) and low luminance visual acuity (LLVA)<br>All endpoints will be carried out at baseline, monthly for the first 3 months and then quarterly until the end of the first year.
- Secondary Outcome Measures
Name Time Method • change in anatomical structures of the retina by SD-OCT (spectral domain optical coherence tomography) and adaptive optics and high-resolution OCT<br>• rate of progression to late stage AMD (geographic atrophy, neovascular AMD)<br>• changes in OCT biomarkers<br>• change in autofluorescence<br>• perfusion of choriocappillaris<br>• subgroup analysis for retinal pseudodrusen (RPD) versus soft drusen (SD)<br>• Amsler-grid analysis<br>• functional tests like multifocal Electroretinogram, mesoptometry, perimetry<br>• ETDRS-Best corrected visual acuity<br>• visual function questionnaire NEI-VFQ-25