Single Center, Prospective, Randomized, Controlled, Non-significant Risk
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|ClinicalTrials.gov Identifier: NCT03286166|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : December 19, 2017
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
|Condition or disease|
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|
|Estimated Enrollment :||20 participants|
|Official Title:||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)|
|Estimated Study Start Date :||January 2018|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||September 2018|
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 [ Time Frame: 3 months ]
- Change in EDS questionnaire from baseline
- Change in TBUT from baseline.
- The improvement of signs and visual analog pain scale in the study group is larger than the improvement of signs in the control group [ Time Frame: 3 months ]
- Change in corneal and/or conjunctival SPK
- Visual analog pain scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286166
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|