Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome

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

NA

Study Classification

INTERVENTIONAL

Brief Summary

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To compare the therapeutic effect between autologous serum and umbilical cord serum eyedrops in the treatment of severe dry eye syndrome.

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Detailed Description

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Ninety-two eyes of 48 patients with severe dry eye syndrome (34 eyes of 17 patients with Sjögren's syndrome and 58 eyes of 31 patients with non-Sjögren's syndrome) were treated with either 20% autologous serum (41 eyes of 21 patients) or umbilical cord serum eyedrops (51 eyes of 27 patients). Symptom scoring, corneal sensitivity test, tear film break-up time (BUT), Schirmer test, tear clearance rate (TCR), corneal fluorescein staining, and conjunctival impression cytology were performed before and 1 month and 2 months after treatment.

Conditions

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Dry Eye Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Umbilical cord serum eyedrops

Intervention Type DRUG

Autologous serum eyedrops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with severe dry eye syndrome who were refractory to conventional treatments and had symptoms of dry eye for more than 3 months
* Low tear film break-up time (BUT, \< 5 sec)
* Low Schirmer test (5 mm)
* Positive fluorescein or rose bengal vital staining (≥ 3)

Exclusion Criteria

* Active ocular infection or inflammation not associated with dry eye
* Contact lens wear
* Ocular allergy
* Ocular surgery within the recent 3 months
* Lid or lash abnormalities
* Pregnant or lactating women

Minimum Eligible Age

20 Years

Maximum Eligible Age

61 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No