Status:
WITHDRAWN
Autologous Plasma Treatment for Severe Dry Eye Patients
Lead Sponsor:
Singapore National Eye Centre
Collaborating Sponsors:
Health Science Authority Singapore
Conditions:
Dry Eye
Eligibility:
All Genders
21-99 years
Phase:
EARLY_PHASE1
Brief Summary
Patients with severe dry eye who have exhausted conventional treatment are not uncommon and are difficult to manage. They and their physicians are helpless when faced with these scenarios. A small HPR...
Detailed Description
Dry eye is a multi-factorial disease that is frequently encountered in ophthalmological practice. Common dry eye symptoms include eye irritation, heaviness of the eyelids, blurred vision and light sen...
Eligibility Criteria
Inclusion
- Patients with dry eye symptoms, who cannot be satisfactorily managed by currently available dry eye medication
- TBUT ≤10s
- Presence of corneal fluorescein staining
- Visual acuity affected by poor tear film quality
- No contraindication for blood extraction/ plasmapheresis
- Age between 21 to 99 years old
- Skin lesions - The skin at the site of venepuncture in the antecubital area should be free of lesions. Donors with boils, open wounds, chronic eczema or any severe skin infection must be rejected.
Exclusion
- Active ocular infection.
- Any other specified reason as determined by clinical investigator
- Severe cardiovascular disease
- Severe respiratory disease
- Uncontrolled epilepsy
- Abnormal bleeding conditions
- Pregnancy
- Infectious diseases
- Patients who are known or diagnosed to have HIV, Hepatitis B or Hepatitis C carriers should not be accepted for donation.
- Patients who have risk factors for infectious diseases should not be accepted for donation.
- Patients who have been or are being treated for bacteraemia, or have a significant bacterial infection that can be associated with bacteraemia.
- Unable to come for follow up at the required frequencies and duration. This includes non-Singapore residents who are patients of the dry eye clinic.
- In order to avoid serious infections, especially corneal keratitis, we will not include patients with high risks for infection in this study, such as those patients with a persistent epithelial defect, wearing of contact lenses, previous ocular surgery such as penetrating keratoplasty or any other ocular surgery.
- Patients with persistent epithelial defect that requires bandage contact lens
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03768115
Start Date
November 1 2018
End Date
October 14 2020
Last Update
October 22 2020
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore, 169856