Cataract, Healing Wound, Surgical Injury
Conditions
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.
Interventions
OTHERpreservative-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%.
Sponsors
Wrocław University of Science and Technology
Spektrum Center of Clinical Ophthalmology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Intraocular pressure measurement | up to 21 days post-surgery | Intraocular pressure measurement preformed by standard tonometer |
| 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) |
| 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 |
| 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 |
Countries
Poland
Outcome results
None listed