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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healing Wound; Cataract; Surgical Injury
• Intervention / Treatment: Other: preservative-free solution of standard post-cataract eye drops

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Wrocław, Poland, 54-622
    • Spektrum Clinic of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: preservatives-free dexamethasone 0.1% eye drops	Other: 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%.
Placebo Comparator: preserved dexamethasone 0.1% eye drops	Other: 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%.

What is the study measuring?

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 Surface Disease Index survey result	a standard survey that patient will preform at each visit	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

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

Collaborators and Investigators

• Sponsor: Spektrum Center of Clinical Ophthalmology
• Collaborators: Wrocław University of Science and Technology
• Investigators: Principal Investigator: Maria Muzyka-Woźniak, PhD, Spektrum Clinic of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Lens Diseases; Cataract; Intraoperative Complications; Capsule Opacification; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Spektrum2022/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No