Status:

COMPLETED

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

Lead Sponsor:

Universidad Nacional de Colombia

Conditions:

Dry Eye

Sjogren Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • • 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

  • • 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

Key Trial Info

Start Date :

November 30 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 20 2016

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT02257957

Start Date

November 30 2014

End Date

April 20 2016

Last Update

August 24 2021

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