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

Spektrum Center of Clinical Ophthalmology

Status: Active, not recruiting

Conditions: Surgical Injury; Cataract; Healing Wound

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05753787

Spektrum2022/01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

preservatives-free dexamethasone 0.1% eye drops

Active Comparator group

Treatment:

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

preserved dexamethasone 0.1% eye drops

Placebo Comparator group

Treatment:

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