Safety and efficacy in the treatment of vitreous floaters with ophthalmic laser
Phase 2
Recruiting
- Conditions
- Other vitreous opacitiesH43.3
- Registration Number
- RBR-2jq3v9
- Lead Sponsor
- Instituto de Assistência Médica ao Servidor Público Estadual - SP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Symptomatic Weiss ring (due to posterior vitreous detachment); Symptoms for at least 6 months; Posterior vitreous detachment documented in clinical examination and ocular ultrasound (B-scan); Weiss ring located at least 3mm from the retina and 5mm from the lens, if phakic; If both eyes are symptomatic, only one will undergo the procedure
Exclusion Criteria
Patients unfit for, or refusing to, sign the ICF; Associated diseases that may compromise data analysis; Visual acuity in the other eye worse than 20/50; History of retinal detachment, uveitis, macular edema, glaucoma and aphakia in the studied eye
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare objective and subjective data of symptom improvement in patients with symptomatic vitreous detachment submitted to the vitreolysis procedure with Nd: YAG laser and to compare them with those same data of patients submitted to the simulated procedure.<br>The objective data will be evaluated by means of retinography six months after the procedure.<br>The subjective data will be evaluated with an improvement score reported by the patient six months after the procedure.
- Secondary Outcome Measures
Name Time Method Assess the safety of the procedure by reporting possible complications in the six-month period<br>Evaluate the NEI-VFQ 25 score before and six months after the procedure<br>Evaluate contrast sensitivity test before and six months after the procedure<br>Evaluate intraocular pressure before and six months after the procedure