NCT03286166

Single Center, Prospective, Randomized, Controlled, Non-significant Risk

A Randomized Controlled Trial to Evaluate the Efficiency of Serum Tears Made With Genius PRP for Improving Signs and Symptoms in Dry Eye Disease (DED)

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 22 Years – 85 Years
• Healthy volunteers: Accepted

Summary

A randomized controlled trial to evaluate the efficiency of serum tears made with Genius PRP for improving signs and symptoms in Dry Eye Disease (DED). Single center, Prospective, Randomized, Controlled, Non-significant risk

Detailed description

Genius PRP is a class II medical device with an 510(k)FDA clearance for platelet and plasma separation for bone graft handling. Subjects will sign the IC form within one week of being having been provided the form, at which time they will undergo the following assessments: * Routine ophthalmology tests (biomicroscopy, BCVA and IOP) including corneal fluorescein staining and lissamine green conjunctival staining * Measurement of tear break up time (TBUT) in both eyes. These values will be used as baseline. * Self-administration of the Eye Dryness Scale; 0-100 visual analogue scale. This score will be used as baseline. * Self-administration of Visual Analog Pain Scale * Eligible subjects will be randomized with right eye to receive PRP and left eye to receive vehicle eye drops in the same dosage. Outcome measures will be assessed in both eyes.

Conditions

• Dry Eye

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2017-09-18
• Last updated: 2023-12-12

Locations

1 site across 1 country: United States