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The Pattern of Dry Eye Disease After Cataract Surgery

L

Lithuanian University of Health Sciences

Status

Enrolling

Conditions

Cataract
Dry Eye Disease
Ocular Surface Disease

Treatments

Device: Artificial tears (sodium hyaluronate 0.2%)

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Patients who will be using artificial tears before and after cataract surgery
Description:
Patients will receive artificial tears 7 days before the cataract surgery and continue to use them for 3 months after the surgery.
Treatment:
Device: Artificial tears (sodium hyaluronate 0.2%)
Patients who will not be using any artificial tears neither before nor after the cataract surgery.
Description:
Patients will not receive any artificial tears neither before nor after the cataract surgery.

Trial contacts and locations

1

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Central trial contact

Reda Zemaitiene; Laura Kapitanovaite

Data sourced from clinicaltrials.gov

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