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Development and validation of a clinical severity scale in persons with watery eyes

Development and validation of the TEARS grading scale: a clinical tool for grading the severity of epiphora

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12877117
Enrollment
107
Registered
2018-11-06
Start date
2018-11-07
Completion date
Unknown
Last updated
2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiphora (watery eye) Eye Diseases Epiphora

Interventions

This is an observational study. It is expected that some participants will undergo medical or surgical intervention as part of their planned medical care (but not determined or influenced by their inc

Sponsors

Queen Victoria Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged over 18 years 2. Diagnosed by an ophthalmologist with experience in lacrimal pathology as having a cause of epiphora amenable to surgical or non-surgical intervention (including tear outflow obstruction, excess eyelid laxity, eyelid malposition, lacrimal hypersecretion or reflex epiphora secondary to evaporative dry eye) 3. Participant is willing and able to give informed consent for participation in the study 4. Participant is fluent in written and spoken English language

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

MeasureTime frame
The TEARS scale will be completed at baseline by two clinicians and at the follow-up appointment (3-6 months after any intervention). The TEARS scale has been developed and gone through multiple iterations by our group through extensive literature review, patient focus groups and consultation with an expert panel of consultant ophthalmologists. Disease severity is graded based on 4 subscales: symptom frequency, the effects on patients and healthcare providers, patients’ functional status, and the compounding effect of ocular surface disease. A fifth subscale is used postoperatively to record patient-reported success as a percentage.

Secondary

MeasureTime frame
1. The Watery Eye Quality of Life (WEQOL) score is a 10-item patient-administered questionnaire that takes most people approximately 5 minutes to complete. This is a disease-specific quality of life tool whose development is evidence-based and is undergoing further validation studies in patients with surgically-amenable epiphora. 2. The Lacrimal Symptom Questionnaire (Lac-Q) is a 9-item patient-administered questionnaire that takes approximately 5 minutes to complete. This is a validated scale of symptom severity and social impact that has to date been used in published studies involving approximately 400 patients. Both the WEQOL and Lac-Q will be completed at baseline and again at follow-up 3-6 months after any intervention. 3. The Glasgow Benefit Inventory (GBI) is a validated 18-item questionnaire that has been used in patients with epiphora to evaluate changes in psychological, social and physical well-being. The GBI will be completed at the final study visit 3-6 months after any intervention.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026