Clinical trial NCT06298890: The Pattern of Dry Eye Disease After Cataract Surgery
Official title: Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Disease
Cataract
Ocular Surface Disease
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Santen Oy
First posted: 2024-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation in this study is voluntary. Research participants will be recruited during a routine visit to an ophthalmologist at Lithuanian University of Health Sciences Hospital Kaunas Clinics, Ophthalmology Department.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of ocular surface changes following cataract surgery
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Evaluation of the cornea morphology
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Evaluation of tear osmolarity
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Evaluation of tear cytokine levels
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Assessment of central corneal sensitivity
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Secondary outcomes:
measure: Evaluation of potential pain biomarkers in patients' saliva
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Dry Eye Questionnaire-5 (DEQ5) 5-item
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Ocular surface disease index (OSDI)
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Visual function (VFQ-25) questionnaire
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
measure: Visual acuity evaluation (LogMAR)
timeFrame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
References: