NCT05753787

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

October 23, 2022

Last Update Submit

September 25, 2023

Conditions

CataractSurgical InjuryHealing Wound

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (5)

  • Fluorescein Break-up Time assessment

    up to 21 days post-surgery

  • SICCA scale assessment

    up to 21 days post-surgery

  • Shirmer test 1 measurement

    up to 21 days post-surgery

  • Intraocular pressure measurement

    up to 21 days post-surgery

  • Anterior chamber cell intensity measurement

    up to 21 days post-surgery

Study Arms (2)

preservatives-free dexamethasone 0.1% eye drops

ACTIVE COMPARATOR
Other: preservative-free solution of standard post-cataract eye drops

preserved dexamethasone 0.1% eye drops

PLACEBO COMPARATOR
Other: preservative-free solution of standard post-cataract eye drops

Interventions

preservative-free solution of standard post-cataract eye dropsOTHER

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

preservatives-free dexamethasone 0.1% eye dropspreserved dexamethasone 0.1% eye drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spektrum Clinic of Ophthalmology

Wroclaw, 54-622, Poland

Location

Related Publications (1)

  • 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.

    PMID: 37903818DERIVED

MeSH Terms

Conditions

CataractIntraoperative Complications

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maria Muzyka-Woźniak, PhD

    Spektrum Clinic of Ophthalmology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2022

First Posted

March 3, 2023

Study Start

January 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

PL(1)