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



Status:Not yet recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - 85
Updated:12/21/2017
Start Date:January 2018
End Date:September 2018

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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)

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.

Inclusion Criteria:

- 1) Able to read, understand and sign an Informed Consent (IC) form 2) 22-85 years of
age 3) Able and willing to comply with the treatment/follow-up schedule and
requirements 4) Tear break up time of less than 10 seconds in both eyes 5) SPK in the
conjunctiva and/or cornea of each eye 6) Eye dryness scale of 40 or greater at
baseline for each eye 7) Self- reported ocular pain from dry eye disease

Exclusion Criteria:

1) Unwilling to discontinue use of contact lenses for the duration of the study 2) Ocular
surgery or eyelid surgery, within 3 months prior to screening 3) Neuro-paralysis in the
planned treatment area, within 6 months prior to screening 4) Other uncontrolled eye
disorders affecting the ocular surface, for example active allergies 5) Punctal plugs
placed within past 90 days 6) Pre-cancerous lesions, skin cancer or pigmented lesions in
the planned treatment area 7) Uncontrolled infections or uncontrolled immunosuppressive
diseases 8) Subjects with current ocular infections. 9) New prescription eye drops for dry
eye or glaucoma or omega 3 supplements prescribed within 90 days prior to screening,
excluding artificial tears 10) New topical treatments within the area to be treated, or
oral therapies, within 3 months prior to screening- except over-the-counter
acetaminophen-based analgesics for pain management 11) Change in dosage of any systemic
medication, within 3 months prior to screening 12) Anticipated relocation or extensive
travel outside of the local study area preventing compliance with follow-up over the study
period 13) Legally blind in one or both eyes 14) First IPL treatment, within 3 months prior
to screening 15) Any condition revealed during the eligibility screening process whereby
the investigator deems the subject inappropriate for this study
We found this trial at
1
site
Nashville, Tennessee 37203
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from
Nashville, TN
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