Actively Recruiting
Ocular Surface and Corneal Morphological Changes After Cataract Surgery and Associations With Inflammatory Biomarkers
Led by Lithuanian University of Health Sciences · Updated on 2024-03-07
100
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
L
Lithuanian University of Health Sciences
Lead Sponsor
S
Santen Oy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring patterns of dry eye disease (DED) after cataract surgery, focusing on changes to the eye surface and cornea, patients' personal assessment of symptoms, and links with eye inflammation and pain markers. This observational study involves adults aged 50 to 90 who have undergone uncomplicated cataract surgery performed by the same experienced surgeon, aiming to understand the long-term effects on ocular health. Participants are divided into two groups: one will use artificial tears (sodium hyaluronate 0.2%) starting 7 days before surgery and continuing for 3 months after the procedure, applied four times daily. The other group will not use any artificial tears before or after surgery. The study tracks these groups over time to compare outcomes related to eye surface lubrication and healing. Throughout the study, participants undergo multiple assessments before surgery and at 1 week, 1 month, 3 months, 6 months, and 12 months after surgery. These include evaluations of eye surface changes, corneal structure, tear composition including inflammatory markers, eye sensitivity, and visual function tests. Questionnaires about dry eye symptoms and quality of vision are also completed. The study monitors these measures to understand how cataract surgery and tear treatment affect eye health over a year.
CONDITIONS
Brief Title
The Pattern of Dry Eye Disease After Cataract Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cataract patients aged 50 to 90 years who underwent uncomplicated phacoemulsification by the same experienced surgeon
- No underlying ocular surface diseases such as keratitis or keratoconjunctivitis
- No previous ophthalmic surgery
You will not qualify if you...
- Patient chooses not to participate or decides to discontinue after enrolling
- Severe dry eye disease diagnosed by symptoms and tests including TBUT less than 10 seconds, tear osmolarity above 308 mOsm/l, or positive corneal staining
- Diagnosis of glaucoma
- Diabetes mellitus
- Systemic connective tissue or autoimmune diseases
- Neurologic conditions such as stroke, Bell's palsy, Parkinson's disease, or trigeminal nerve dysfunction
- Previous refractive surgery like LASIK or PRK
- Use of contact lenses
- Use of psychiatric medicines, antihistamines, or hormonal replacement
- Regular use of topical eye drops or ointments already in place
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants who will use artificial tears start using them 7 days before cataract surgery and continue for 3 months after surgery. Participants who do not use artificial tears undergo cataract surgery without this intervention.
Visits at 7 days preoperative, 1 week, 1 month, and 3 months postoperative
Duration - Up to 12 months postoperative
Participants are monitored for ocular surface and corneal changes as well as biomarker evaluations up to 12 months after cataract surgery.
Visits at 6 and 12 months postoperative
Trial Site Locations
Total: 1 location
1
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT-44307
Actively Recruiting
Research Team
R
Reda Zemaitiene
L
Laura Kapitanovaite
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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