Dry Eye, Sjogren Syndrome
Conditions
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.
Interventions
DRUGPRP injection
DRUGStandard 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
Sponsors
Universidad Nacional de Colombia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Staining | 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. |
| Change From Baseline in Shirmer Test | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Platelet -Rich Plasma (PRP) 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90
PRP injection | 15 |
| 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
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 | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Platelet -Rich Plasma (PRP) | Standard Care | Total |
|---|---|---|---|
| Age, Continuous | 52.9 years STANDARD_DEVIATION 3.5 | 52.7 years STANDARD_DEVIATION 3.5 | 52.7 years STANDARD_DEVIATION 3.5 |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet -Rich Plasma (PRP) | Change From Baseline in Ocular Surface Staining | 1.2 score on a scale | Standard Deviation 0.18 |
| Standard Care | Change From Baseline in Ocular Surface Staining | 2.4 score on a scale | Standard Deviation 0.18 |
Primary
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
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet -Rich Plasma (PRP) | Change From Baseline in Shirmer Test | 9.2 mm | Standard Deviation 1 |
| Standard Care | Change From Baseline in Shirmer Test | 5.3 mm | Standard Deviation 0.7 |
Secondary
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.
Time frame: 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Platelet -Rich Plasma (PRP) | Change From Baseline in Ocular Surface Disease Index (OSDI) | 34 score on a scale | Standard Deviation 4 |
| Standard Care | Change From Baseline in Ocular Surface Disease Index (OSDI) | 55 score on a scale | Standard Deviation 2.5 |