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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet -Rich Plasma (PRP) | Experimental | 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 |
|
| Standard Care | Active Comparator | 15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP injection | Drug |
| ||
| Standard care Hyaluronic acid eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days |
| 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 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
• Patients with symptomatic Dry eye
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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29970389 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marcel Y Avila | Universidad Nacional de Colombia | +5713165000 | 15119 | myavilac@unal.edu.co |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
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| 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 |
|
| 90 days |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 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 | Posted | Mean | Standard Deviation | mm | 90 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | 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 | 0 | 15 | 0 | 15 |
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| D007592 |
| Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |