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

Primary Purpose

Cataract, Surgical Injury, Healing Wound

Status
Active
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
preservative-free solution of standard post-cataract eye drops
Sponsored by
Spektrum Center of Clinical Ophthalmology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spektrum Clinic of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

preservatives-free dexamethasone 0.1% eye drops

preserved dexamethasone 0.1% eye drops

Arm Description

Outcomes

Primary Outcome Measures

Best corrected visual acuity result
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
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/
Ocular Surface Disease Index survey result
a standard survey that patient will preform at each visit

Secondary Outcome Measures

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)
SICCA scale assessment
Scale that requires both fluorescein and lissamine green staining profile assesment - used in the standardised manner
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
Intraocular pressure measurement
Intraocular pressure measurement preformed by standard tonometer
Anterior chamber cell intensity measurement
the standardised SUN assesment of the anterior chamber cell intensity will be preformed - a standardised scale

Full Information

First Posted
October 23, 2022
Last Updated
September 25, 2023
Sponsor
Spektrum Center of Clinical Ophthalmology
Collaborators
Wrocław University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05753787
Brief Title
Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
Acronym
EyeSurface
Official Title
Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spektrum Center of Clinical Ophthalmology
Collaborators
Wrocław University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Surgical Injury, Healing Wound

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
preservatives-free dexamethasone 0.1% eye drops
Arm Type
Active Comparator
Arm Title
preserved dexamethasone 0.1% eye drops
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
preservative-free solution of standard post-cataract eye drops
Intervention Description
Usage of preservative-free eye drops in comparison to the standard preserved drops with dexamethasone 0.01%.
Primary Outcome Measure Information:
Title
Best corrected visual acuity result
Description
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Time Frame
up to 21 days post-surgery
Title
Ocular staining score result
Description
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/
Time Frame
up to 21 days post-surgery
Title
Ocular Surface Disease Index survey result
Description
a standard survey that patient will preform at each visit
Time Frame
up to 21 days post-surgery
Secondary Outcome Measure Information:
Title
Fluorescein Break-up Time assessment
Description
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)
Time Frame
up to 21 days post-surgery
Title
SICCA scale assessment
Description
Scale that requires both fluorescein and lissamine green staining profile assesment - used in the standardised manner
Time Frame
up to 21 days post-surgery
Title
Shirmer test 1 measurement
Description
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
Time Frame
up to 21 days post-surgery
Title
Intraocular pressure measurement
Description
Intraocular pressure measurement preformed by standard tonometer
Time Frame
up to 21 days post-surgery
Title
Anterior chamber cell intensity measurement
Description
the standardised SUN assesment of the anterior chamber cell intensity will be preformed - a standardised scale
Time Frame
up to 21 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Muzyka-Woźniak, PhD
Organizational Affiliation
Spektrum Clinic of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spektrum Clinic of Ophthalmology
City
Wrocław
ZIP/Postal Code
54-622
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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