Strip Meniscometry in Dry Eye Evaluation

November 1, 2023 updated by: Zuzana Schreiberova, University Hospital Olomouc

Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Department of Ophthalmology, University Hospital Olomouc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Group will be recruited from patients who undergo cataract surgery at the Department of Ophthalmology of University Hospital Olomouc and Palacky University.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in strip meniscometry.
Time Frame: Week 1, 4, 12
Strip Meniscometry Tube in millimeters.
Week 1, 4, 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ocular surface fluorescein staining.
Time Frame: Week 1, 4, 12
Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).
Week 1, 4, 12
Change in tear film stability.
Time Frame: Week 1, 4, 12
Tear break up time test in seconds.
Week 1, 4, 12
Change in lid-parallel conjunctival folds evaluation.
Time Frame: 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).
Week 1, 4, 12
Change in Ocular Surface Disease Index.
Time Frame: Week 1, 4, 12
Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).
Week 1, 4, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Collaborators

Palacky University

Investigators

  • Principal Investigator: Marta Karhanova, MD, PhD, University Hospital Olomouc and Palacky University Olomouc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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