dry eye
Conditions
Interventions
Cyclosporine + OPT group:Cyclosporine + OPT
OPT group:OPT
Sponsors
The Second Affiliated Hospital Medical College of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years old. Those who fully understand the trial, voluntarily sign the informed consent form, follow up as required, and complete the trial process; 2. Patients with SS diagnosed by a rheumatologist. The diagnosis of specific SS adopts the latest SS classification criteria proposed by the 2016 International SS Standards Working Group ACR/EULAR, when the sum of the following five scores is >= 4, and the specific rules include: (1) Pathological biopsy of the labial gland showed lymphocyte foci >=1 foci/4mm 2 , scoring 3 points; (2) Saliva flow rate = 5 in at least one eye; 1 point; 3. The following 4 points must be met at the same time to be diagnosed as moderate to severe dry eye: OSDI questionnaire score (0-100) >= 23; tear break-up time (BUT) = 5 points; 4. Fitzpatrick skin types I to IV.
Exclusion criteria
Exclusion criteria: Patients had receive implants beneath the treatment area or acure solar dermatitis, allergic disease, eye surgery less than one month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Standard Ocular Surface Disease Index (OSDI);tear film breakup time;Schirmer test;river of tears height;best corrected visual acuity;intraocular pressure;corneal conjunctival staining; | — |
Countries
China
Contacts
Public ContactHuo Yanan
Department of Ophthalmology, the Second Affiliated Hospital Medical College of Zhejiang University
Outcome results
None listed