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| Name | Class |
|---|---|
| Wrocław University of Science and Technology | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preservatives-free dexamethasone 0.1% eye drops | Active Comparator |
| |
| preserved dexamethasone 0.1% eye drops | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| preservative-free solution of standard post-cataract eye drops | Other | Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Muzyka-Woźniak, PhD | Spektrum Clinic of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spektrum Clinic of Ophthalmology | Wroclaw | 54-622 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37903818 | Derived | Muzyka-Wozniak M, Strozecki L, Przezdziecka-Dolyk J. Assessment of the eye surface and subjective symptoms after using 0.1% dexamethasone drops with and without preservatives in patients after cataract surgery. Sci Rep. 2023 Oct 30;13(1):18625. doi: 10.1038/s41598-023-44939-1. |
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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 |
| ID | Term |
|---|---|
| D002386 | Cataract |
| D007431 | Intraoperative Complications |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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