AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

Chengdu University of Traditional Chinese Medicine30 enrolled

Overview

The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.

Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effect on corneal nerves. Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Sjogren's Syndrome Dry Eye Ocular Surface Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts. * Age 18-65 years old. * Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial. * At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids. Exclusion Criteria: * Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS. * Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases. * Those who have a history of previous ocular oprations, eye injuries or contact lenses usage. * Known hypersensitivity to experimental drugs or any of its ingredients. * Necessity to modify the systemic treatment of previous diseases during the trial. * Pregnancy or lactation. * Severe systemic disease.

Outcomes

Primary Outcomes

cornea nerves

cornea sub-basal nerve density

Time frame: 12 weeks

cornea staining score

to evaluate corneal epithelial repair（0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30）

Time frame: 4 weeks

Secondary Outcomes

Ocular Surface Disease Index (OSDI)

to assess the quality of life and clinical symptom；The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)

Time frame: 4 weeks

Schirmer's test

to assess tear flow

Time frame: 4 weeks

tear film breakup time (TBUT)

to assess tear film stability

Time frame: 4 weeks

AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes