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

Cataract Clinical Trial

— EyeSurface  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05753787
• Other study ID #: Spektrum2022/01
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Spektrum Center of Clinical Ophthalmology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Healing Wound
• Intraoperative Complications
• Surgical Injury

Intervention

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%.

Locations

Country	Name	City	State
Poland	Spektrum Clinic of Ophthalmology	Wroclaw

Sponsors (2)

Lead Sponsor	Collaborator
Spektrum Center of Clinical Ophthalmology	Wroclaw University of Science and Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Ocular Surface Disease Index survey result	a standard survey that patient will preform at each visit	up to 21 days post-surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Intraocular pressure measurement	Intraocular pressure measurement preformed by standard tonometer	up to 21 days post-surgery
Secondary	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