Strip Meniscometry in Dry Eye Evaluation

Completed

• Conditions: Dry Eye; Dry Eye Disease

• Registration Number: NCT06120894
• Lead Sponsor: University Hospital Olomouc

Brief Summary

Strip meniscometry is a relatively new method for evaluating the tear meniscus. The aim of the study is to evaluate the possible effect of cataract surgery on ocular surface disease and to assess the possible benefit of strip meniscometry in the preoperative and postoperative evaluation of patients.

Detailed Description

Cataract surgery is one of the most successful anterior segment surgeries and usually results in excellent postoperative visual acuity. However, some patients may experience symptoms of dry eye disease after a successful procedure, most commonly a foreign body sensation in the eye, intermittent pain, and blurred vision. These problems then interfere with normal daily activities and also reduce the patient's satisfaction with the surgery.

The new method for tear film examination Strip meniscometry (SM) appears to be a suitable alternative to the Schirmer test. SM values correlate with Oxford score (fluorescein staining), tear break up time test or measurement of meniscus height using anterior segment optical coherence tomography. It is a minimally invasive and rapid examination method that measures the volume of the aqueous component of the tear film.

The aim of this study is to evaluate the possible influence of cataract surgery on the development of iatrogenic OSD and to assess the contribution of a new diagnostic method, SM, for the evaluation of OSD before and after cataract surgery.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• age over 18 years
• performing of pre-operative examination before cataract surgery
• signed informed consent

Exclusion Criteria

• use of antiglaucoma drugs
• chronic blepharitis
• previous viral keratitis
• previous keratoplasty or laser refractive surgery
• known systemic disease causing changes on ocular surface (diabetes mellitus, connective tissue disease)
• use of medication causing changes on ocular surface (antidepressant, beta blockers)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in strip meniscometry.	Week 1, 4, 12	Strip Meniscometry Tube in millimeters.

Secondary Outcome Measures

Name	Time	Method
Change in lid-parallel conjunctival folds evaluation.	Week 1, 4, 12	Lid-parallel conjunctival folds (LIPCOF) grading from 0 (no conjunctival folds) to 3 (more than two permanent and clear parallel folds (normally higher than 0.2 mm).
Change in ocular surface fluorescein staining.	Week 1, 4, 12	Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).
Change in Ocular Surface Disease Index.	Week 1, 4, 12	Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).
Change in tear film stability.	Week 1, 4, 12	Tear break up time test in seconds.

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital Olomouc; 🇨🇿 Olomouc, Czechia