Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 to 80 years. Presence of dry eye symptoms (OSDI 6 more than or equal to 4) and at least one clinical sign of DED (NIBUT less than10 secs, TMH less than or equals to 0.20 mm, or mucin lissamine green staining and more than 9 punctate spots). Willingness to provide informed consent and comply with follow-up visits. Literate patients can read and complete validated questionnaires (OSDI 6 symptom tools).
Exclusion criteria
Exclusion criteria: History of ocular surgery (e.g., refractive or cataract surgery) within the past 12 months. Active ocular infection or severe ocular surface disease at baseline. Use of topical ocular medications within 24 hours before baseline evaluation. Corneal scarring or irregularities interfere with tear film assessment. Inability or unwillingness to adhere to the follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the change in the OSDI-6 score from baseline to 3 months and 6 months, providing insight into the improvement or persistence of patient-reported symptoms at baseline 3 months and 6 months.Timepoint: At baseline 3 months and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will include changes in objective clinical parameters such as non-invasive tear break- up time (NITBUT), tear meniscus height (TMH), & ocular surface staining patterns, which together reflect tear film stability, tear volume, & ocular surface integrity, respectively. Additionally, the study will 3 evaluate the stability of subclassification over the follow-up period to determine whether patients remain in the same diagnostic category or transition between subtypes. Finally, differences in treatment response will be analyzed across the various TFOS DEWS III-defined subtypes of dry eye disease, thereby allowing the identification of subtype-specific therapeutic outcomes & highlighting the need for tailored management strategies.Timepoint: At baseline 3 months & 6 months. | — |
Countries
India
Contacts
Nethradhama Super speciality eye hospital