Clinical Trial: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Use of Autologous Serum Eye-drops as Tears in Patients With Recalcitrant Dry Eye

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 Summary: 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.
Sponsor: Singapore National Eye Centre

Current Primary Outcome: Staining [ Time Frame: 4 months ]

Grading of punctate corneal staining in the worse eye (second visit relative to first visit)


Original Primary Outcome: Grading of punctate corneal staining in the worse eye (second visit relative to first visit) [ Time Frame: 4 months ]

Current Secondary Outcome:

  • Symptoms [ Time Frame: 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 .

  • Tear-production [ Time Frame: 4 months ]
    Schirmers test result
  • Tear-proteins [ Time Frame: 4 months ]
    Tear protein analysis
  • Tear-stability [ Time Frame: 4 months ]
    Tear break up time
  • Cornea [ Time Frame: 4 months ]
    other corneal findings such as scarring, vascularisation, filaments etc
  • Conjunctiva [ Time Frame: 4 months ]
    Documentation of conjunctival hyperemia, chemosis, scarring


Original Secondary Outcome:

  • Change in Visual Analog Score (Global score is calculated from 2 scores: frequency and severity of dry eye symptoms [ Time Frame: 4 months ]
    From Schaumberg D et al Ocular Surface 2009.
  • Schirmers test result [ Time Frame: 4 months ]
  • Tear protein analysis [ Time Frame: 4 months ]
  • Tear break up time [ Time Frame: 4 months ]
  • Other corneal findings (scarring, vascularisation, filaments etc) [ Time Frame: 4 months ]
  • Documentation of conjunctival hyperemia, chemosis, scarring [ Time Frame: 4 months ]


Information By: Singapore National Eye Centre

Dates:
Date Received: March 16, 2010
Date Started: July 2010
Date Completion:
Last Updated: January 15, 2012
Last Verified: January 2012