Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
NCT ID: NCT05753787
Last Updated: 2023-09-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2022-01-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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preservatives-free dexamethasone 0.1% eye drops
preservative-free solution of standard post-cataract eye drops
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
preserved dexamethasone 0.1% eye drops
preservative-free solution of standard post-cataract eye drops
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
Interventions
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preservative-free solution of standard post-cataract eye drops
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Wrocław University of Science and Technology
OTHER
Spektrum Center of Clinical Ophthalmology
OTHER
Responsible Party
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Principal Investigators
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Maria Muzyka-Woźniak, PhD
Role: PRINCIPAL_INVESTIGATOR
Spektrum Clinic of Ophthalmology
Locations
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Spektrum Clinic of Ophthalmology
Wroclaw, , Poland
Countries
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References
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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.
Other Identifiers
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Spektrum2022/01
Identifier Type: -
Identifier Source: org_study_id
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