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| Name | Class |
|---|---|
| Hospital Dr Sotero del Rio | OTHER |
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The purpose of this study is to compare the effects of autologous serum 20% and autologous serum 50% for the treatment of Severe Dry Eye Syndrome
To determine the difference between autologous serum 20% vs 50%, in terms of improvement of symptoms, improvement of ocular surface parameters and acceptable tolerability in patients with severe dry eye syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous Serum 20% | Active Comparator | Treatment with Autologous Serum 20% for 2 months |
|
| Autologous Serum 50% | Active Comparator | Treatment with Autologous Serum 50% for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Serum 20% | Drug | Instillation of 1 drop of Autologous Serum 20% four times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ocular Surface Disease Index (OSDI) Score | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tear Break Up Time (TBUT) | The TBUT is based on the time of tear rupture after the instillation of fluorescein. The shorter the time of rupture, the greater the tear dysfunction | 1 week, 1 month, 2 months |
| Change in Oxford Staining score |
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Inclusion Criteria:
Man/woman ≥ 18 years old, able to freely give consent to participate in the study
At least 1 of the following tests altered:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paulina Liberman, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Dr. Sótero del RÃo | Puente Alto | Santiago Metropolitan | Chile |
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| Autologous Serum 50% | Drug | Instillation of 1 drop of Autologous Serum 50% four times a day |
|
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The Oxford scale is based on the amount of ocular surface (cornea and conjunctiva) that is stained with lysine or green fluorescein. The severity of the staining points is classified into 6 stages (0-5) from absent to marked epithelial damage.
| 1 week, 1 month, 2 months |
| Change in Schirmer I | It is a tear production test. The Schirmer I test is performed without anesthesia. Two thin strips of filter paper (Whatman 5mm x 35mm) are placed on the bottom of the lower conjunctival sac at the junction of the middle third and the outer third to prevent injury to the cornea. It is recommended to ask the subject to keep their eyes closed to limit the effect of blinking. The strips are kept positioned for 5 minutes and then they are removed and the amount that was moistened is read, in mm. The lower the value, the greater the deficit of tear production | 1 week, 1 month, 2 months |
| Change in Ocular Surface Disease Index (OSDI) Score | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The overall OSDI score defines the ocular surface as normal (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) disease. | 1 week, 2 months |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| D012859 | Sjogren's Syndrome |
| D003316 | Corneal Diseases |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
| D007766 | Lacrimal Apparatus Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| 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 |
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