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

Last updated: July 29, 2021
Sponsor: Universidad Nacional de Colombia
Overall Status: Completed

Phase

3

Condition

Lupus

Dermatomyositis (Connective Tissue Disease)

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT02257957
plasmadry10
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • • Patients who are currently engaged in another clinical trial, unwilling or unable togive 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 systemicimmunosuppressant.
  • Concomitant use of systemic antibiotics or steroids.
  • Contact lens wear
  • Active ocular infection or allergy
  • Unable to close eyes or uncontrolled blinking

Study Design

Total Participants: 30
Study Start date:
November 30, 2014
Estimated Completion Date:
April 20, 2016

Study 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 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.