Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT03286166
Brief 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.
Study:
NCT03286166
Study Brief:
Protocol Section:
NCT03286166