Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases (NCT01975103) | Clinical Trial Compass
UnknownPhase 2
Non-damaging Retinal Laser Therapy With PASCAL Laser for Macular Diseases
Brazil20 participantsStarted 2013-03
Plain-language summary
This trial seeks to prove the safety and efficacy of photothermal stimulation treatment to diabetic macular edema, chronic central serous retinopathy, macular edema secondary to branch retinal vein occlusion and macular telangiectasia.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient must have macular edema involving the center of the macula with a corresponding leakage on fluorescein angiography.
Thickening of the fovea of at least 300 microns (thickness of the central point in OCT) with a standard deviation of the center point \<10% and signal strength of ≥ 5 OCT ILM and borders (internal limiting membrane) and RPE (retinal pigment epithelium) properly identified. Also, the initial OCT must be confirmed by repeated measurements on the same day, with the thickness of the central point being within 10% between measurements. In cases where the OCT imaging program can not properly define the limits of ILM and RPE, if the investigator can obtain an estimate of the thickness of the manual by OCT central point of at least 300 microns, the patient will be considered eligible.
The distance visual acuity in the better eye corrected the study must have an index between 70 and 35 letters inclusive (Snellen equivalent of 20/40 to 20/200).
Clear media and eye pupil dilation adequate to allow fundus photography with good quality.
Intraocular pressure not exceeding 21 mmHg. The ophthalmologist should feel comfortable with the delay of the focal laser treatment (direct and grid, as needed) by at least 12 weeks in the study eye.
Patients with diabetes Type I or Type II as defined by WHO criteria of any gender and age ≥ 18 years.
Ability to provide a written consent. Ability to return for all study visits.
Exclusion Criteria:
* E…