Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
ConditionDry Eye Syndromes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Rochester
About this trial
This is a single center double-masked study with up to four visits. Subjects who have been diagnosed with dry-eye syndrome at Flaum Eye Institute will be enrolled. The purpose of the study is to determine if using platelet rich plasma drops can improve clinically significant dry eye in patients and determine if there is a difference with using two different uses of the plasma tear drops: platelet rich plasma tears and plasma tears without platelets.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects must be diagnosed with clinically significant dry eye.
Subjects have no active ocular disease or allergic conjunctivitis.
Subjects must not be using any topical ocular medications within two weeks prior to enrollment.
Subjects must be willing and able to follow instructions.
Disqualifiers
Is pregnant at the time of enrolment in the study determined by urine pregnancy test.
Is currently on a course of antibiotics
Is considered by the Investigator to not be a suitable candidate for participation and are not at risk for glaucoma.
Is considered by the University of Rochester Transfusion Medicine & Blood Bank not a suitable candidate for blood donation.
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet Poor Plasma Tear Drops
Other interventionParticipant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet free fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of white blood cells (WBC), red blood cells (RBC), and platelets when compared to the concentration before processing.
Platelet Rich Plasma Tear Drops
Other interventionParticipant blood will be drawn and processed by the University of Rochester Transfusion Medicine and Blood Bank. Processing will isolate the platelet fraction of the blood plasma. After processing, plasma should contain ≤ 5% concentration of WBC and RBC and 100 x 10³ μl or ≥ 50% recovery of platelets when compared to the pre-platelet count.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Platelet Poor Plasma TearActive comparator 1 intervention
Group B: Platelet Rich Plasma TearsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in acuity
Acuity will be measured using a Shack-Hartmann Wavefront Sensor. Subjects will be seated in front of the wavefront sensor. They will be asked to blink naturally fixate on the laser spot throughout the measurement protocol. While subjects fixate, the wavefront sensor delivers a brief flash of light to the subjects' retina. The light reflected out of the subjects' eye is collected to obtain measurements of wavefront aberrations of the eye. For optical quality assessments the measurements of wavefront aberrations will be acquired along the line-of-sight. The wavefront data acquired from the wavefront sensor will be described by Zernike coefficients, the most popular mathematical way to represent the ocular aberrations.
Time frame
baseline to 3 months2
Mean change in breakup pattern to appear
This will be measured using a Placido Disk. The subject places their chin on a chin rest and look into the disk system. The system uses an incandescent or broad-band area LED for illumination.
Time frame
baseline to 3 months3
Mean change in lipid coverage of the cornea with blinking
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Time frame
baseline to 3 months4
Mean change in consistency of lipid compensation
This will be measured using a Ellipsometer/Tearscope. This instrument uses a modified slit-lamp head restraint and an imaging system to visualize the surface of the subject's cornea. Structurally the system is a clinical slit-lamp system. However, the system uses an electronic camera instead of a human observer. The illumination system uses a diffuse ring illuminator instead of a slit-lamp. The data from this instrument identifies changes in the lipid thickness and the refractive index over the cornea.
Time frame
baseline to 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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