avilas™ laser versus classic frequency doubled Nd-YAG (532 nm) laser therapy for diabetic macular edema. A randomized study analyzing the effect on central visual function.
Completed
- Conditions
- Diabetic macular edema.
- Registration Number
- NL-OMON22871
- Lead Sponsor
- The Rotterdam Eye Hospital /Het Oogziekenhuis Rotterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
1. Informed consent;
2. Age 30 years or older;
Exclusion Criteria
1. Other ocular condition affecting macular function or obscuring ocular media, thereby influencing visual acuity and/or central visual sensitivity;
2. Previous panretinal laser;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of microperimetry outcome (dB) at 6 months.
- Secondary Outcome Measures
Name Time Method 1. Change of microperimetry outcome (dB) at 3, 9 and 12 months;<br /><br>2. Change of BCVA (ETDRS), CFT (OCT), autofluorescence (objective macular damage) at 3, 6, 9, 12 months;<br /><br>3. Change of total area of laser burns or retinal pigment epithelium atrophy over time.