NCT06120894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

November 1, 2023

Last Update Submit

November 1, 2023

Conditions

Dry EyeDry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Change in strip meniscometry.

    Strip Meniscometry Tube in millimeters.

    Week 1, 4, 12

Secondary Outcomes (4)

  • Change in ocular surface fluorescein staining.

    Week 1, 4, 12

  • Change in tear film stability.

    Week 1, 4, 12

  • Change in lid-parallel conjunctival folds evaluation.

    Week 1, 4, 12

  • Change in Ocular Surface Disease Index.

    Week 1, 4, 12

Interventions

Central visual acuityDIAGNOSTIC_TEST

Measurement of central visual acuity using Snellen optotype chart.

Intraocular pressure measurementDIAGNOSTIC_TEST

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

Slit lamp examinationDIAGNOSTIC_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 keratometryDIAGNOSTIC_TEST

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

Optical biometryDIAGNOSTIC_TEST

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

Strip meniscometry (SM)DIAGNOSTIC_TEST

Strip meniscometry examination using strip meniscometry tube.

Lid Parallel Conjunctival Folds test (LIPCOF)DIAGNOSTIC_TEST

Evaluation of lid parallel conjunctival folds using slit lamp examination.

Staining of the ocular surface with fluoresceinDIAGNOSTIC_TEST

Evaluation of ocular surface fluorescein staining using Oxford scheme.

Tear break up time test (TBUT)DIAGNOSTIC_TEST

Evaluation of tear break up time using slit lamp examination.

Ocular Surface Disease Index questionnaire (OSDI)OTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital Olomouc

Olomouc, Czechia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Tonometry, OcularSlit Lamp MicroscopyRefraction, Ocular

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, OphthalmologicalDiagnostic Techniques and ProceduresDiagnosisVision TestsOptical PhenomenaPhysical PhenomenaOcular Physiological Phenomena

Study Officials

  • Marta Karhanova, MD, PhD

    University Hospital Olomouc and Palacky University Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

November 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

CZ(1)