Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye

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.

Study Overview

• Status: Suspended
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: Platelet Poor Plasma Tear Drops; Other: Platelet Rich Plasma Tear Drops

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James Aquavella, MD; Phone Number: 585-273-3937; Email: james_aquavella@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Flaum Eye Institute at the University of Rochester
      • Contact: James Aquavella, MD; Phone Number: 585-273-3937; Email: james_aquavella@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• Subjects must have voluntarily agreed to participate in the study by signing the statement of informed consent.
• Subjects must meet plasma donor criteria as established by University of Rochester Transfusion Medicine & Blood Bank.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Platelet Poor Plasma Tear	Other: Platelet Poor Plasma Tear Drops; Participant 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.
Experimental: Platelet Rich Plasma Tears	Other: Platelet Rich Plasma Tear Drops; Participant 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline to 3 months
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.	baseline to 3 months
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.	baseline to 3 months
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.	baseline to 3 months
Mean change in temperature over the optical service	This will be measured using a Thermal Imaging System. A thermal imaging system will be used to provide spatially-resolved thermal maps of the subject's eyes and face adjacent to the eyes. This camera system is non-invasive and is mounted on a tripod about 12" from the subject's eyes. It images the heat that is emitted by the subject at frame rates from 2 to 10 Hz. The camera displays a spatially resolved map (approximately 0.2 x 0.2 mm pixel size) of the ocular surface temperature. IR detection is a convenient tool for instantaneous temperature measurement of the ocular surface and allows monitoring of time course change as well.	baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: STUDY00004552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No