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Safety and efficacy in the treatment of vitreous floaters with ophthalmic laser

Safaey and efficacy in ND-Yag laser vitreolysis for symptomatic vitreous floaters: a prospective randomized trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-2jq3v9
Enrollment
Unknown
Registered
2019-03-04
Start date
2018-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other vitreous opacities

Interventions

The study population will be divided into two groups of fifteen people: 1) The first group will be submitted to Nd-YAG laser vitreolysis of vitreous opacitie. The amount of laser will depend on the in
Procedure/surgery

Sponsors

Instituto de Assistência Médica ao Servidor Público Estadual - SP
Lead Sponsor
Instituto de Assistência Médica ao Servidor Público Estadual - SP
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. The objective data will be evaluated by means of retinography six months after the procedure. The subjective data will be evaluated with an improvement score reported by the patient six months after the procedure.

Secondary

MeasureTime frame
Assess the safety of the procedure by reporting possible complications in the six-month period Evaluate the NEI-VFQ 25 score before and six months after the procedure Evaluate contrast sensitivity test before and six months after the procedure Evaluate intraocular pressure before and six months after the procedure

Countries

Brazil

Contacts

Public ContactGustavo Ludwig

Instituto de Assistência Médica ao Servidor Público Estadual - SP

guludwig@gmail.com+55-011-5549-2937

Outcome results

None listed

Source: REBEC (via WHO ICTRP)