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The purpose of this study is to examine the efficacy and safety of autologous serum eye drops in people with recalcitrant dry eye.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serum eye drops | Experimental | Patient's autologous serum is diluted in saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous serum eyedrops | Drug | 3 times a day for the duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Staining | Grading of punctate corneal staining in the worse eye (second visit relative to first visit) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | 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 . | 4 months |
| Tear-production |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Tong, FRCS, MD | Singapore National Eye Centre | Principal Investigator |
| Ronald Chung | Singapore National Eye Centre | Principal Investigator |
| Roger Beuerman | Singapore Eye Research Institute | Study Director |
| Mickey Koh | Singapore General Hospital | Study Chair |
| Samanthila Waduthantri | Singapore National Eye Centre | Study Chair |
| Heng Joo Ng | Singapore General Hospital | Study Chair |
| Rohani Salleh | Singapore General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore National Eye Centre | Singapore | Singapore | 168571 | Singapore |
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| ID | Term |
|---|---|
| D014985 | Xerophthalmia |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
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Schirmers test result
| 4 months |
| Tear-proteins | Tear protein analysis | 4 months |
| Tear-stability | Tear break up time | 4 months |
| Cornea | other corneal findings such as scarring, vascularisation, filaments etc | 4 months |
| Conjunctiva | Documentation of conjunctival hyperemia, chemosis, scarring | 4 months |