Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

July 29, 2021 updated by: Universidad Nacional de Colombia
Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Patients with symptomatic Dry eye

    • Shirmer ≤10 mm in 5 min
    • BUT ≤10 seconds
    • Corneal staining ≥3
    • Age range: 18 years and older.
    • Both genders and all ethnic groups comparable with the local community.
    • Able to understand and willing to sign a written informed consent
    • Able and willing to cooperate with the investigational plan.
    • Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

  • • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

    • Children under 18.
    • Pregnant women or expecting to be pregnant during the study.
    • Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
    • Concomitant use of systemic antibiotics or steroids.
    • Contact lens wear
    • Active ocular infection or allergy
    • Unable to close eyes or uncontrolled blinking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet -Rich Plasma (PRP)
15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
Drug: PRP injection
Active Comparator: Standard Care
15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
Drug: Standard care Hyaluronic acid eye drops
: 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Ocular Surface Staining
Time Frame: 90 days
Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.
90 days
Change From Baseline in Shirmer Test
Time Frame: 90 days
The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Ocular Surface Disease Index (OSDI)
Time Frame: 90 days

The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye.

The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Colombia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2014

Primary Completion (Actual)

September 30, 2015

Study Completion (Actual)

April 20, 2016

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

October 2, 2014

First Posted (Estimate)

October 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • plasmadry10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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