Health Condition 1: H188- Other specified disorders of cornea
Conditions
Interventions
Intervention1: OSDx: Participants will undergo diagnostic evaluation using the OSDx device to assess its diagnostic performance for Dry Eye Disease (DED). The total duration of the intervention will b
Sponsors
Remidio Innovative Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Normals and dry eye subjects (based on OSDI score)
Exclusion criteria
Exclusion criteria: Subjects who are pregnant and nursing Subjects with recent eye surgery or trauma Individuals with uncontrolled systemic diseases such as diabetes autoimmune disorders or Sjogrens syndrome which can contribute to dry eye Subject with ocular diseases such as Glaucoma Diabetic Retinopathy Cataract ARMD Uveitis infections and inflammation Subjects undertaking medication like Antihistamines Beta-blockers Antidepressants or other Glaucoma medications for example prostaglandin analogs which may affect tear film structure or quality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definition: Diagnostic accuracy of OSDx compared to Clinical expert and predicate device (OSA plus) Measurement: Sensitivity, specificity, positive and negative predictive valuesTimepoint: At the time of a single clinical visit (Day 0); repeat testing in 20% of participants within 1 7 days to assess test retest reliability | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of OSDx & predicate device parameters (TMH, MG loss %, blink rate analysis, & Lipid Layer Thickness). Differences in diagnostic parameters between OSDx & predicate device (e.g., mean TM ROC, MGD, etc.). Agreement between device-based diagnoses (OSDx & predicate device) & clinical expert diagnosis. Classification performance of the OSDx & predicate devices in subgroups of dry eye severity. Inter & Intra observer repeatability in subset of participants for OSDx device.Timepoint: Repeat testing within 1 7 days from initial visit (only in 20% subset) rest everything will be done at the time of single diagnostic visit (Day 0) | — |
Countries
India
Contacts
Public ContactRanjitha K
Dr Shroffs Charity Eye Hospital
Outcome results
None listed