Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-03-31
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients who will be using artificial tears before and after cataract surgery
Patients will receive artificial tears 7 days before the cataract surgery and continue to use them for 3 months after the surgery.
Artificial tears (sodium hyaluronate 0.2%)
Patients randomised into Ist study group will use artificial tears 7 days before the cataract surgery 4 times a day and they will continue to use them after surgery for 3 months.
Patients who will not be using any artificial tears neither before nor after the cataract surgery.
Patients will not receive any artificial tears neither before nor after the cataract surgery.
No interventions assigned to this group
Interventions
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Artificial tears (sodium hyaluronate 0.2%)
Patients randomised into Ist study group will use artificial tears 7 days before the cataract surgery 4 times a day and they will continue to use them after surgery for 3 months.
Eligibility Criteria
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Inclusion Criteria
* Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
* Patients who previously did not undergo any ophthalmic surgery.
Exclusion Criteria
* Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining.
* Glaucoma.
* Diabetes mellitus.
* Systemic connective tissue disease, autoimmune disease.
* Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction.
* Patients who underwent refractive surgery (LASIK or PRK).
* Contact lens users.
* One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement.
* Patients who are already regularly using topical drops or ointments.
50 Years
90 Years
ALL
No
Sponsors
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Santen Oy
INDUSTRY
Lithuanian University of Health Sciences
OTHER
Responsible Party
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Reda Zemaitiene
Professor, Head of the Department of Ophthalmology at the Lithuanian University of Health Sciences
Locations
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Lithuanian University of Health Sciences
Kaunas, , Lithuania
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SASKAT
Identifier Type: -
Identifier Source: org_study_id
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