Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery

Study Overview
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Brief Summary
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The goal of this interventional, real world data study is to evaluate the impact of preservatives on the post-cataract ocular surface. The main question is to learn about an effect of preservatives on the eye surface. The study aims to answer some important questions: if the usage of preservatives has an impact on the eye surface healing process after cataract surgery if patient comfort and quality of life improve more or more rapidly with preservatives-free eye drops. Participants will be asked to undergo standard procedure of peri-cataract surgery care and in addition to survey about the ocular surface state. Researchers will compare group that takes preservatives-free dexamethasone 0.1% with standard dexamethasone 0.01% solution to see if post-surgery eye surface healing properties differ from both groups.

Official Title
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Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery

Conditions
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Cataract, Surgical Injury, Healing Wound

Intervention / Treatment
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* Other: preservative-free solution of standard post-cataract eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cataract surgery required defined previously by the eye-care specialist good and clear visibility of the anterior chamber in the pre-surgery status (enables investigators to assess the anterior chamber cell intensity) consent to the study protocol Exclusion Criteria: diagnosed glaucoma diagnosed previous allergy diagnosed diabetic retinopathy or maculopathy previously diagnosed dry eye disease that requires treatment with multiple artificial tears permanent usage of the eye drops other than artificial tears non-compliance to the study protocol

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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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: preservatives-free dexamethasone 0.1% eye drops<br> | Other: preservative-free solution of standard post-cataract eye drops<br>* Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.<br>|
| Placebo Comparator: preserved dexamethasone 0.1% eye drops<br> | Other: preservative-free solution of standard post-cataract eye drops<br>* Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity result | best corrected visual acuity evaluated with standard ETDRS for distant and for near vision | up to 21 days post-surgery | 
| Ocular staining score result | standard staining score - a scale used with the fluorescein stain; higher value expres more severe outcome, normal values are around 0-1. Overal information can be found: https://entokey.com/a-simplified-quantitative-method-for-assessing-keratoconjunctivitis-sicca-from-the-sjogrens-syndrome-international-registry/ | up to 21 days post-surgery | 
| Ocular Surface Disease Index survey result | a standard survey that patient will preform at each visit | up to 21 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein Break-up Time assessment | time to break-up the tear film after the instilation of the fluorescein eye drop (evaluated 3 fold and the mean will be taken into account) | up to 21 days post-surgery | 
| SICCA scale assessment | Scale that requires both fluorescein and lissamine green staining profile assesment - used in the standardised manner | up to 21 days post-surgery | 
| Shirmer test 1 measurement | test that evaluate the amount of tears (in mm on the test paper) that are produced within 5 minutes and are evaluated under the anesthesia | up to 21 days post-surgery | 
| Intraocular pressure measurement | Intraocular pressure measurement preformed by standard tonometer | up to 21 days post-surgery | 
| Anterior chamber cell intensity measurement | the standardised SUN assesment of the anterior chamber cell intensity will be preformed - a standardised scale | up to 21 days post-surgery |