Health Condition 1: O- Medical and Surgical Health Condition 2: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 5–70 years 2. Have OSDI scores =33 or Oxford staining grade =2 3. Diagnosis of DED in both eyes supported by the criteria mentioned below a.A symptom severity score of =33 for OSDI b.An unanesthetized Schirmer Tear Test (STT) score of =1 mm and =5 mm per 5 minutes c.Evidence of ocular surface staining (total fluorescein staining score of at least 3) [0-15 scale]) 4. Have normal lid anatomy and diagnosed with severe dry eye (ATDDE) 5. DED refractory to medical management
Exclusion criteria
Exclusion criteria: 1.History of punctal occlusion or punctal dilation. 2.Active ocular infection or inflammation. 3.Use of punctal plugs within the past 3 months. 4.Pregnancy or lactation women. 5.Any systemic or ocular condition that may interfere with the study assessments or participant safety. 6.Punctal plug or contact lenses. 7.Ocular surgery within 6 months. Have no contraindication for blood donation 8.Positive HIV, hepatitis B or C, or syphilis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in dry eye symptoms assessed using validated questionnaires such as the Ocular Surface Disease Index (OSDI) score.Timepoint: 1 month, 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity, Adverse events related to interventionTimepoint: 1 month and 3 months | — |
Countries
India
Contacts
L V Prasad Eye Institute