Strip Meniscometry in Dry Eye Evaluation

NCT ID: NCT06120894

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-09-30

Brief Summary

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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

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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.

Conditions

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Dry Eye Dry Eye Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Central visual acuity

Measurement of central visual acuity using Snellen optotype chart.

Intervention Type DIAGNOSTIC_TEST

Intraocular pressure measurement

Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.

Intervention Type DIAGNOSTIC_TEST

Slit lamp examination

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).

Intervention Type DIAGNOSTIC_TEST

Refraction and keratometry

Measurement of refraction and keratometry using refractometer Nidek ARK-1a.

Intervention Type DIAGNOSTIC_TEST

Optical biometry

Measurement of optical biometry using biometer Argos (Barrett or SRK/T formula).

Intervention Type DIAGNOSTIC_TEST

Strip meniscometry (SM)

Strip meniscometry examination using strip meniscometry tube.

Intervention Type DIAGNOSTIC_TEST

Lid Parallel Conjunctival Folds test (LIPCOF)

Evaluation of lid parallel conjunctival folds using slit lamp examination.

Intervention Type DIAGNOSTIC_TEST

Staining of the ocular surface with fluorescein

Evaluation of ocular surface fluorescein staining using Oxford scheme.

Intervention Type DIAGNOSTIC_TEST

Tear break up time test (TBUT)

Evaluation of tear break up time using slit lamp examination.

Intervention Type DIAGNOSTIC_TEST

Ocular Surface Disease Index questionnaire (OSDI)

Evaluation of Ocular Surface Disease Index using Ocular Surface Disease Index questionnaire.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palacky University

OTHER

Sponsor Role collaborator

University Hospital Olomouc

OTHER

Sponsor Role lead

Responsible Party

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Zuzana Schreiberova

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Karhanova, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Olomouc and Palacky University Olomouc

Locations

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Department of Ophthalmology, University Hospital Olomouc

Olomouc, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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24/22

Identifier Type: -

Identifier Source: org_study_id

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