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Completed

NCT Number: NCT06120894

Strip Meniscometry in Dry Eye Evaluation

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.

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Key information

Conditions

Dry Eye Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology, University Hospital Olomouc

Olomouc, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

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 fluorescein

Diagnostic 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.

Primary outcomes

  1. Change in strip meniscometry.

    Time frame: Week 1, 4, 12

    Strip Meniscometry Tube in millimeters.

Secondary outcomes

  1. 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).

  2. Change in tear film stability.

    Time frame: Week 1, 4, 12

    Tear break up time test in seconds.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 7, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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