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
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 Type
OBSERVATIONAL
Toyos Clinic
Nashville, Tennessee, United States
The difference in the change of EDS score from baseline and the tear breakup time from baseline to follow-up, between study eyes in the study arm and study eyes in the control arm
* Change in EDS questionnaire from baseline * Change in TBUT from baseline.
Time frame: 3 months
The improvement of signs and visual analog pain scale in the study group is larger than the improvement of signs in the control group
* Change in corneal and/or conjunctival SPK * Visual analog pain scale
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.