Xerophthalmia
Conditions
Brief summary
The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
Detailed description
A group of selected dry eye patients from the Singapore National Eye Centre who have exhausted the usual treatment options (lubricants, topical immunosuppressive and punctal occlusion) and not keen for tarsorrhaphy will be recruited. After informed consent, they will undergo plasmapheresis and start on daily autologous serum eyedrops for a period of 4 months. Clinical monitoring for standard dry eye parameters such as punctate corneal keratitis, Schirmers testing, tear break up time as well as severity and frequency of dry eye symptoms will be conducted. Tear inflammatory proteins captured on Schirmers paper pre and post treatment will be analysed as well.
Interventions
3 times a day for the duration of the study
Sponsors
Singapore National Eye Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Seen at the dry eye service at the Singapore National Eye Centre * Age between 21 and 75 years old * Symptomatic for dry eye or VA worse than 6/12 in Snellen chart * Presence of corneal punctate staining involving central zone * Exhausted what is considered as standard therapy or therapy that is acceptable to the patient and the physician * No contraindication for blood extraction/plasmapheresis
Exclusion criteria
* HIV/HCV/HBV/syphilis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Staining | 4 months | Grading of punctate corneal staining in the worse eye (second visit relative to first visit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear-production | 4 months | Schirmers test result |
| Tear-proteins | 4 months | Tear protein analysis |
| Symptoms | 4 months | The change in Visual Analog Score (Schaumberg D et al Ocular Surface 2009). The global score is calculated from 2 scores, the frequency and severity of dry eye symptoms. From . |
| Cornea | 4 months | other corneal findings such as scarring, vascularisation, filaments etc |
| Conjunctiva | 4 months | Documentation of conjunctival hyperemia, chemosis, scarring |
| Tear-stability | 4 months | Tear break up time |
Countries
Singapore
Outcome results
None listed