The Pattern of Dry Eye Disease After Cataract Surgery

NCT ID: NCT06298890

Last Updated: 2024-03-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2027-09-30

Brief Summary

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This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.

Detailed Description

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Conditions

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Dry Eye Disease Cataract Ocular Surface Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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%)

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon.
* Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
* Patients who previously did not undergo any ophthalmic surgery.

Exclusion Criteria

* Patient expressed his wish to not participate in the study or discontinue it when already enrolled.
* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen Oy

INDUSTRY

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reda Zemaitiene

Professor, Head of the Department of Ophthalmology at the Lithuanian University of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lithuanian University of Health Sciences

Kaunas, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Reda Zemaitiene

Role: CONTACT

+37037327064

Laura Kapitanovaite

Role: CONTACT

+37037327064

Facility Contacts

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Reda Zemaitiene

Role: primary

+ 370 37 327 201

Other Identifiers

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SASKAT

Identifier Type: -

Identifier Source: org_study_id

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