Clinical trial NCT06120894: Strip Meniscometry in Dry Eye Evaluation
Official title: Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye
Dry Eye Disease
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Palacky University
First posted: 2023-11-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: Change in strip meniscometry.
timeFrame: Week 1, 4, 12
Secondary outcomes:
measure: Change in ocular surface fluorescein staining.
timeFrame: Week 1, 4, 12
measure: Change in tear film stability.
timeFrame: Week 1, 4, 12
measure: Change in lid-parallel conjunctival folds evaluation.
timeFrame: Week 1, 4, 12
measure: Change in Ocular Surface Disease Index.
timeFrame: Week 1, 4, 12
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Department of Ophthalmology, University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc and Palacky University Olomouc
name: Marta Karhanova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: