Strip Meniscometry in Dry Eye Evaluation

Study Overview
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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.

Official Title
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Strip Meniscometry in Dry Eye Evaluation in Connection With Cataract Surgery

Conditions
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Dry Eye, Dry Eye Disease

Intervention / Treatment
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* Diagnostic Test: Central visual acuity
* Diagnostic Test: Intraocular pressure measurement
* Diagnostic Test: Slit lamp examination
* Diagnostic Test: Refraction and keratometry
* Diagnostic Test: Optical biometry
* Diagnostic Test: Strip meniscometry (SM)
* Diagnostic Test: Lid Parallel Conjunctival Folds test (LIPCOF)
* Diagnostic Test: Staining of the ocular surface with fluorescein
* Diagnostic Test: Tear break up time test (TBUT)
* Other: Ocular Surface Disease Index questionnaire (OSDI)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in strip meniscometry. | Strip Meniscometry Tube in millimeters. | Week 1, 4, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change in tear film stability. | Tear break up time test in seconds. | Week 1, 4, 12 | 
| 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 | 
| 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 |