Strip Meniscometry in Dry Eye Evaluation | NCT06120894

Studies
Strip Meniscometry in Dry Eye Evaluation

NCT06120894

Sponsor

University Hospital Olomouc

Status

Completed

Last Update Posted

Nov 7, 2023Actual

Enrollment

21Actual

Phase

Not provided

Conditions

Dry Eye
Dry Eye Disease

Interventions

Central visual acuity
Intraocular pressure measurement
Slit lamp examination
Refraction and keratometry
Optical biometry
Strip meniscometry (SM)
Lid Parallel Conjunctival Folds test (LIPCOF)
Staining of the ocular surface with fluorescein
Tear break up time test (TBUT)
Ocular Surface Disease Index questionnaire (OSDI)

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Nov 1, 2023

First Submission Date that Met QC Criteria

Nov 1, 2023

First Posted Date

Nov 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2023

Last Update Posted Date

Nov 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zuzana Schreiberova, Principal Investigator, University Hospital OlomoucPrincipal Investigator

Lead Sponsor

University Hospital OlomoucOTHER

Collaborators

Name	Class
Palacky University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
Central visual acuity	Diagnostic Test	Measurement of central visual acuity using Snellen optotype chart.
Intraocular pressure measurement	Diagnostic Test	Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.
Slit lamp examination	Diagnostic Test	Slit lamp examination of the anterior and posterior segment of the eye after pharmacological dilation of the pupil using application of short-time mydriatics (1% tropicamide and 10% phenylephrine).
Refraction and keratometry	Diagnostic Test	Measurement of refraction and keratometry using refractometer Nidek ARK-1a.
Optical biometry	Diagnostic Test	Measurement of optical biometry using biometer Argos (Barrett or SRK/T formula).

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in ocular surface fluorescein staining.	Oxford scheme grading with range from 0 (none staining dots) to 5 (severe dry eye).	Week 1, 4, 12
Change in tear film stability.	Tear break up time test in seconds.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marta Karhanova, MD, PhD	University Hospital Olomouc and Palacky University Olomouc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Ophthalmology, University Hospital Olomouc		Olomouc			Czechia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D014065	Tonometry, Ocular
D000072776	Slit Lamp Microscopy
D012029	Refraction, Ocular

ID	Term
D003941	Diagnostic Techniques, Ophthalmological
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014787	Vision Tests
D055620	Optical Phenomena
D055585	Physical Phenomena
D009799	Ocular Physiological Phenomena