An observational study in Dry Eye, sponsored by Toyos Clinic. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Toyos Clinic · Observational
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:
Outcome measures will be assessed in both eyes.
Up to 20 male or female subjects, aged 22-85, with signs and symptoms of DED and ocular pain related to DED in the opinion of the investigator
Exclusion Criteria:
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20 subjects will undergo one session of PRP in which 60 cc of blood is drawn and centrifuged into 3 months of autologous serum tears. • Subjects will utilize autologous tears twice daily in the study eye.
Subjects in the control arm will receive study vehicle to be used twice daily in the left eye.
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
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Toyos Clinic