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 edema1004706010012653
- Registration Number
- NL-OMON35722
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 99
Inclusion Criteria
Informed consent.
Age 30 years or older.
Recently diagnosed DME (< 3 months).
Diabetes mellitus (i.e. at least 1 year of treatment, and a HbA1c < 10 %).
Able to cooperate with assessments of visual acuity, retinal imaging and microperimetry.
Exclusion Criteria
Other ocular condition affecting macular function or obscuring ocular media, thereby influencing visual acuity and/or central visual sensitivity.
Previous panretinal laser.
Intraocular injections or surgery (< 3 months prior to inclusion).
Planned laser, intravitreal injections or surgery (phaco/vitrectomy) within 12 months after inclusion.
Fluorescein allergy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change of microperimetry outcome (dB) at 6 months.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Change of microperimetry outcome (dB) at 3, 9 and 12 months.<br /><br>Change of BCVA (ETDRS), CFT (OCT), autofluorescence (objective macular damage)<br /><br>at 3, 6, 9, 12 months.<br /><br>Change of total area of laser burns or retinal pigment epithelium atrophy over<br /><br>time.</p><br>