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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Xerophthalmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serum eye drops

Patient's autologous serum is diluted in saline solution

Group Type EXPERIMENTAL

Autologous serum eyedrops

Intervention Type DRUG

3 times a day for the duration of the study

Interventions

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Autologous serum eyedrops

3 times a day for the duration of the study

Intervention Type DRUG

Eligibility Criteria

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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