Health Condition 1: M350- Sicca syndrome [Sjogren]
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
Hyderabad Eye Research Foundation
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosis of Sjogrens syndrome based on the American European Consensus Group 2002 revised criteria which requires the presence of at least 4 of 6 criteria or 3 of 4 objective criteria. The 6 criteria include - subjective and objective ocular dryness - subjective and objective evidence of salivary gland involvement (as determined by sialometry, sialography, or salivary gland scintigraphy) -presence of SSA/Ro, SSB/La, or both -positive minor salivary gland biopsy. A mandatory criterion for the diagnosis of primary SS was either positive serology (SSA or SSB) or positive minor salivary gland biopsy result.
Exclusion criteria
Exclusion criteria: - Pregnant and nursing mothers - Ocular infections, and ocular or refractive surgery in the last three months - Trauma to the globe, contact lens users. - Chronic users of any systemic or topical drugs causing dry eyes, such as antihistamines, anticholinergics, beta-blockers, diuretics, antidepressants, antipsychotics, and hormone replacement therapy, birth control pills or intrauterine devices (IUD) - Women with surgical menopause, the paediatric population, and psychiatric patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in symptoms (OSDI) and signs (Ocular surface staining scores) at 6 months as compared with baseline. A minimum of 10% reduction will be taken as improvement.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Improvement in OSDI and in Ocular surface staining scores at 3 and 12 months 2. Improvement in Schirmer and Flourescein break-up score at 3, 6 and 12 months 3. Reduced frequency of adjuvants (lubricants) at 3, 6 and 12 monthsTimepoint: 3,6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Smruti Rekha Priyadarshini
L V Prasad Eye Institute
Outcome results
None listed