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

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ClinicalTrials.gov Identifier: NCT02257957
Recruitment Status : Completed
First Posted : October 7, 2014
Results First Posted : August 24, 2021
Last Update Posted : August 24, 2021
Sponsor:
Information provided by (Responsible Party):
Universidad Nacional de Colombia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Sjogren Syndrome Drug: PRP injection Drug: Standard care Hyaluronic acid eye drops Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Actual Study Start Date : November 30, 2014
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : April 20, 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universidad Nacional de Colombia
ClinicalTrials.gov Identifier: NCT02257957    
Other Study ID Numbers: plasmadry10
First Posted: October 7, 2014    Key Record Dates
Results First Posted: August 24, 2021
Last Update Posted: August 24, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Sjogren's Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Ophthalmic Solutions
Hyaluronic Acid
Pharmaceutical Solutions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents