Keratitis
Conditions
Interventions
Treatment with autologous serum eyedrops will be offered for a sample of 40 patients, provided free of charge in partnership with Hemocentro São Lucas (Hemocentro São Lucas – Terapia Celular, CNPJ 57.
Sponsors
Universidade Federal de São Paulo - UNIFESP/EPM
Universidade Federal de São Paulo - UNIFESP/EPM
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age 18 to 80 years. Both genders. Confirmed diagnosis of one of the following pathologies: Sjögren 's syndrome, Moderate to severe non- Sjögren's dry eye, Stevens-Johnson syndrome, Graft versus host disease, Neurotrophic keratitis, Neurotrophic pain. Presence of corneal epithelial defect without improvement after treatment with preservative-free lubricating eye drops for at least 14 days. Absence of active infection on the ocular surface. No recent use of the following medications or performance of the following procedures: anticoagulants/ anti- platelet aggregation, blood product eye drops in the last 3 months, eye surgery in the last 6 months. Does not present any of the following conditions: poorly controlled systemic disease, active infection or advanced-stage cancer, pregnancy or breastfeeding. There are no contraindications to blood donation: positive serology for HIV I and II or HTLV 1/2 or hepatitis B or hepatitis C or syphilis or Chagas disease according to Ordinance 158 of 02/04/2016 of the Ministry of Health – Brazil, anemia (hemoglobin level < 11.0 mg/dl) or thrombocytopenia (platelet level < 150 x 10 9 /L). Ability to adhere to the treatment and follow-up protocol during the study period and provide written consent for participation
Exclusion criteria
Exclusion criteria: Diagnosis of active corneal infection. Pregnancy diagnosed after beginning the protocol. Loss of clinical follow-up. Incorrect adherence to treatment, with application of less than 70% of the expected daily dose or remaining without use for more than one full day a week. Inadequate storage and care of eye drops. Need for other interventions to treat epithelial defect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in the epithelial defect by measuring the diameters in millimeters in the slit lamp examination and by measuring the defect area in pixels in the photophotography using analysis software | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of the presence of metalloproteinases on the ocular surface through qualitative testing ;Improvement in ocular symptoms through a reduction in total score of Ocular Surface Disease Index questionnaire;Improvement in break-up tear time through an increase in time measured in seconds ;Improvement in epithelial lesion pattern through reduction of score by the Oxford Score;Improvement in confocal microscopy aspects through inflammatory and nervous cells analysis ;Improvement in ocular surface parameters evaluated with Idra ® through comparisons between qualitative and quantitative parameters | — |
Countries
Brazil
Contacts
Public ContactÍtalo Oliveira
Universidade Federal de São Paulo - UNIFESP/EPM
Outcome results
None listed