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

Primary Purpose

Dry Eye Syndromes

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Platelet Poor Plasma Tear Drops
Platelet Rich Plasma Tear Drops
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Flaum Eye Institute at the University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Platelet Poor Plasma Tear

Platelet Rich Plasma Tears

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2021
Last Updated
September 6, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT05121493
Brief Title
Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
Official Title
Study of Platelet Rich Plasma Drops to Moderate Clinically Significant Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Suspended
Why Stopped
the trial is on hold due to clinical trials staffing shortages.
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet Poor Plasma Tear
Arm Type
Active Comparator
Arm Title
Platelet Rich Plasma Tears
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Platelet Poor Plasma Tear Drops
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Platelet Rich Plasma Tear Drops
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in acuity
Description
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 months
Title
Mean change in breakup pattern to appear
Description
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 months
Title
Mean change in lipid coverage of the cornea with blinking
Description
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 months
Title
Mean change in consistency of lipid compensation
Description
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 months
Title
Mean change in temperature over the optical service
Description
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.
Time Frame
baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Flaum Eye Institute at the University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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