Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

• Status: Completed
• Trial end date: 2016-04-20
• Target enrollment: 0
• Participant gender: All

Summary

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Nacional de Colombia
• Treatments: Hyaluronic Acid; Ophthalmic Solutions; Tetrahydrozoline

Criteria

Inclusion Criteria:

• • Patients with symptomatic Dry eye

• Shirmer ≤10 mm in 5 min

• BUT ≤10 seconds

• Corneal staining ≥3

• Age range: 18 years and older.

• Both genders and all ethnic groups comparable with the local community.

• Able to understand and willing to sign a written informed consent

• Able and willing to cooperate with the investigational plan.

• Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

• • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

• Children under 18.

• Pregnant women or expecting to be pregnant during the study.

• Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.

• Concomitant use of systemic antibiotics or steroids.

• Contact lens wear

• Active ocular infection or allergy

• Unable to close eyes or uncontrolled blinking