Assessment of the Eye Surface and Subjective Symptoms After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Spektrum Center of Clinical Ophthalmology
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Best corrected visual acuity result
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Best corrected visual acuity result
Time Frame: up to 21 days post-surgery
best corrected visual acuity evaluated with standard ETDRS for distant and for near vision
Ocular staining score result
Time Frame: up to 21 days post-surgery
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/
Ocular Surface Disease Index survey result
Time Frame: up to 21 days post-surgery
a standard survey that patient will preform at each visit
Secondary Outcomes
- 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)
- SICCA scale assessment(up to 21 days post-surgery)
- Fluorescein Break-up Time assessment(up to 21 days post-surgery)