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

Universidad Nacional de Colombia

Status and phase: Completed; Phase 3

Conditions: Sjogren Syndrome; Dry Eye

Treatments: Drug: Standard care Hyaluronic acid eye drops; Drug: PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02257957

plasmadry10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Platelet -Rich Plasma (PRP)

Experimental group

Description:

15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90

Treatment:

Drug: PRP injection

Standard Care

Active Comparator group

Description:

15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90

Treatment:

Drug: Standard care Hyaluronic acid eye drops