Eye Surface Properties After Using Dexamethasone Drops With and Without Preservatives in Patients After Cataract Surgery
- Conditions
- Healing WoundCataractSurgical Injury
- Interventions
- Other: preservative-free solution of standard post-cataract eye drops
- Registration Number
- NCT05753787
- Lead Sponsor
- Spektrum Center of Clinical Ophthalmology
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preserved dexamethasone 0.1% eye drops preservative-free solution of standard post-cataract eye drops - preservatives-free dexamethasone 0.1% eye drops preservative-free solution of standard post-cataract eye drops -
- Primary Outcome Measures
Name Time Method 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
Ocular staining score result 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 up to 21 days post-surgery a standard survey that patient will preform at each visit
- Secondary Outcome Measures
Name Time Method 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
Intraocular pressure measurement up to 21 days post-surgery Intraocular pressure measurement preformed by standard tonometer
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
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
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)
Trial Locations
- Locations (1)
Spektrum Clinic of Ophthalmology
🇵🇱Wrocław, Poland