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NCT Number: NCT02257957

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

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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Key information

Conditions

Dry Eye Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren Syndrome Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PRP injection

Drug

Standard care Hyaluronic acid eye drops

Drug

: 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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Nacional de Colombia

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 7, 2014
Registry last updated
Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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