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Recruiting NCT06298890

The Pattern of Dry Eye Disease After Cataract Surgery

— Observational Dry Eye Disease Cataract Ocular Surface Disease

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial tears (sodium hyaluronate 0.2%).
Who it may be relevant to
Registry conditions: Dry Eye Disease, Cataract, Ocular Surface Disease. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Lithuania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Assessment of ocular surface changes following cataract surgery [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Evaluation of the cornea morphology [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Evaluation of tear osmolarity [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Evaluation of tear cytokine levels [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Assessment of central corneal sensitivity [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
Secondary outcome measures (5)
  • Evaluation of potential pain biomarkers in patients' saliva [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Dry Eye Questionnaire-5 (DEQ5) 5-item [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Ocular surface disease index (OSDI) [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Visual function (VFQ-25) questionnaire [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]
  • Visual acuity evaluation (LogMAR) [Time frame: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Lithuania · 1 center
  • Lithuanian University of Health Sciences — Kaunas

Identifiers

NCT: NCT06298890 · SASKAT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗