Back to resultsPlatelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Primary Purpose
Dry Eye, Sjogren Syndrome
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRP injection
Standard care Hyaluronic acid eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet -Rich Plasma (PRP)
Standard Care
Arm Description
15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
Outcomes
Primary Outcome Measures
Change From Baseline in Ocular Surface Staining
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.
Change From Baseline in Shirmer Test
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
Change From Baseline in Ocular Surface Disease Index (OSDI)
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.
Full Information
NCT ID
NCT02257957
First Posted
September 24, 2014
Last Updated
July 29, 2021
Sponsor
Universidad Nacional de Colombia
1. Study Identification
Unique Protocol Identification Number
NCT02257957
Brief Title
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Official Title
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2014 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
April 20, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Colombia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Sjogren Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet -Rich Plasma (PRP)
Arm Type
Experimental
Arm Description
15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90
Intervention Type
Drug
Intervention Name(s)
PRP injection
Intervention Type
Drug
Intervention Name(s)
Standard care Hyaluronic acid eye drops
Intervention Description
: 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 Measure Information:
Title
Change From Baseline in Ocular Surface Staining
Description
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.
Time Frame
90 days
Title
Change From Baseline in Shirmer Test
Description
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index (OSDI)
Description
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.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Citations:
PubMed Identifier
29970389
Citation
Avila MY, Igua AM, Mora AM. Randomised, prospective clinical trial of platelet-rich plasma injection in the management of severe dry eye. Br J Ophthalmol. 2018 Jul 3:bjophthalmol-2018-312072. doi: 10.1136/bjophthalmol-2018-312072. Online ahead of print.
Results Reference
derived
Learn more about this trial
Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
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