Corneal injury treatment protocol using 50% Autologous Serum Eye Drops

Phase 1

Recruiting

• Conditions: Keratitis; C11.204

• Registration Number: RBR-34d3jv2
• Lead Sponsor: niversidade Federal de São Paulo - UNIFESP/EPM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-27
• Last Update Posted: 19 December 2023
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified