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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Cataract Surgical Injury Healing Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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preservatives-free dexamethasone 0.1% eye drops

Group Type ACTIVE_COMPARATOR

preservative-free solution of standard post-cataract eye drops

Intervention Type OTHER

Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.

preserved dexamethasone 0.1% eye drops

Group Type PLACEBO_COMPARATOR

preservative-free solution of standard post-cataract eye drops

Intervention Type OTHER

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%.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wrocław University of Science and Technology

OTHER

Sponsor Role collaborator

Spektrum Center of Clinical Ophthalmology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Poland

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.

Reference Type DERIVED
PMID: 37903818 (View on PubMed)

Other Identifiers

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Spektrum2022/01

Identifier Type: -

Identifier Source: org_study_id

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