Strip Meniscometry in Dry Eye Evaluation

Dry Eye Clinical Trial

Official title:

Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06120894
• Other study ID #: 24/22
• Status: Completed
• Start date: November 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2023
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Diagnostic Test:
• Central visual acuity
Measurement of central visual acuity using Snellen optotype chart.
• Intraocular pressure measurement
Measurement of intraocular pressure using non-contact Canon TX-20P tonometer.
• 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).
• Refraction and keratometry
Measurement of refraction and keratometry using refractometer Nidek ARK-1a.
• Optical biometry
Measurement of optical biometry using biometer Argos (Barrett or SRK/T formula).
• Strip meniscometry (SM)
Strip meniscometry examination using strip meniscometry tube.
• Lid Parallel Conjunctival Folds test (LIPCOF)
Evaluation of lid parallel conjunctival folds using slit lamp examination.
• Staining of the ocular surface with fluorescein
Evaluation of ocular surface fluorescein staining using Oxford scheme.
• Tear break up time test (TBUT)
Evaluation of tear break up time using slit lamp examination.

Other:
• Ocular Surface Disease Index questionnaire (OSDI)
Evaluation of Ocular Surface Disease Index using Ocular Surface Disease Index questionnaire.

Locations

Country	Name	City	State
Czechia	Department of Ophthalmology, University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in strip meniscometry.	Strip Meniscometry Tube in millimeters.	Week 1, 4, 12
Secondary	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
Secondary	Change in tear film stability.	Tear break up time test in seconds.	Week 1, 4, 12
Secondary	Change in lid-parallel conjunctival folds evaluation.	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).	Week 1, 4, 12
Secondary	Change in Ocular Surface Disease Index.	Ocular Surface Disease Index (OSDI) questionnaire with range from 0 to 100 (higher score represents greater disability).	Week 1, 4, 12