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

• Sponsor: Spektrum Center of Clinical Ophthalmology (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05753787
• Collaborator: Wrocław University of Science and Technology (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract; Surgical Injury; Healing Wound	Other: preservative-free solution of standard post-cataract eye drops	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

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%.

Outcome Measures

Primary Outcome Measures

1. Best corrected visual acuity result [up to 21 days post-surgery]

   best corrected visual acuity evaluated with standard ETDRS for distant and for near vision

2. Ocular staining score result [up to 21 days post-surgery]

   standard staining score - a scale used with the fluorescein stain

3. Ocular Surface Disease Index survey result [up to 21 days post-surgery]

   a standard survey that patient will preform at each visit

Secondary Outcome Measures

1. Fluorescein Break-up Time assessment [up to 21 days post-surgery]

   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)

2. SICCA scale assessment [up to 21 days post-surgery]

   Scale that requires both fluorescein and lissamine green staining profile assesment - used in the standardised manner

3. Shirmer test 1 measurement [up to 21 days post-surgery]

   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

4. Intraocular pressure measurement [up to 21 days post-surgery]

   Intraocular pressure measurement preformed by standard tonometer

5. Anterior chamber cell intensity measurement [up to 21 days post-surgery]

   the standardised SUN assesment of the anterior chamber cell intensity will be preformed - a standardised scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spektrum Clinic of Ophthalmology	Wrocław		Poland	54-622

Sponsors and Collaborators

• Spektrum Center of Clinical Ophthalmology
• Wrocław University of Science and Technology

Investigators

• Principal Investigator: Maria Muzyka-Woźniak, PhD, Spektrum Clinic of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Spektrum Center of Clinical Ophthalmology
• ClinicalTrials.gov Identifier: NCT05753787
• Other Study ID Numbers: Spektrum2022/01
• First Posted: Mar 3, 2023
• Last Update Posted: Mar 3, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Capsule Opacification; Intraoperative Complications; Ophthalmic Solutions

Study Results

No Results Posted as of Mar 3, 2023