The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care

Active, not recruiting

• Conditions: Dry Eye Syndromes

• Registration Number: NCT06913465
• Lead Sponsor: Superior University

Brief Summary

This observational cross-sectional study will assess the impact of hypothyroidism on tear production and tear film stability. Conducted at DHQ Hospital dera ghazi khan over six months, the study will recruit 71 participants aged 20-60 years using a non-probability convenience sampling method. Patients with confirmed hypothyroidism will undergo tear assessment through the Schirmer I test, Tear Breakup Time (TBUT) test, and Ocular Surface Disease Index (OSDI) questionnaire. The Schirmer test will measure tear production, while TBUT will assess tear film stability.

Detailed Description

Ocular surface staining and tear osmolarity will further evaluate ocular health. Patients with systemic conditions affecting tear production, such as diabetes or rheumatoid arthritis, will be excluded. The collected data will be analyzed to determine the relationship between hypothyroidism and dry eye symptoms, aiding in better management of ocular health in hypothyroid patients. The study aims to provide valuable insights into the association between thyroid dysfunction and tear film abnormalities.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-20
• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Last Update Submitted: 2025-03-29
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-06-20
• Study Completion: 2026-02-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Age between 20-60 years.
• Confirmed diagnosis of hypothyroidism with thyroid function tests.
• No prior history of ocular surgery or significant ocular pathology.

Exclusion Criteria

• Use of systemic medications affecting tear production (e.g., antihistamines, diuretics).
• Other systemic conditions (e.g., diabetes, rheumatoid arthritis).
• Pregnancy or lactation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Ocular Surface Disease Index (OSDI)	12 Months	The Ocular Surface Disease Index (OSDI) is a 12-question questionnaire used to assess the severity of dry eye symptoms and their impact on vision-related function, scored on a scale of 0 to 100, with higher scores indicating greater disability.

Trial Locations

Locations (2)

DHQ Hospital; 🇵🇰 Dera Ghazi Khan, Punjab, Pakistan

CENUM Center Mayo Hospital Rd, Anarkali Bazaar; 🇵🇰 Lahore, Punjab, Pakistan