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Active, Not Recruiting

NCT Number: NCT06913465

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

DHQ Hospital, Dera Ghazi Khan, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Ocular Surface Disease Index (OSDI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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