The Pattern of Dry Eye Disease After Cataract Surgery

NCT06298890 | Recruiting

• 1 other identifier: SASKAT
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Disease; Cataract; Ocular Surface Disease

Outcome Measures

Primary Outcomes (6)

• Assessment of ocular surface changes following cataract surgery

  Measured using LacryDiag (Quantel Medical, France), parameters included: non-invasive tear break up time, the height of the tear meniscus, interferometry.

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Evaluation of the cornea morphology

  Evaluated performing confocal corneal microscopy, parameters include: corneal nerve fibre number and density.

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears

  Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of dry eye disease (DED) patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative.

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Evaluation of tear osmolarity

  Evaluated with the TearLab Osmolarity System. Increased osmolarity indicates dry eye. Values greater than 300 mOsm/kg are suggestive of dry eye. From 300 mOsm/L to 320 mOsm/L, is graded as mild; from 320 mOsm/L to 340 mOsm/L, is graded as moderate; and greater than 340 mOsm/L, is graded as severe.

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Evaluation of tear cytokine levels

  Interleukin -2, -6, -1β, tumour necrosis factor α (TNFα), interferon-gamma (IFN-γ) levels in tears are significantly higher in patients' with dry eye disease (DED) and they correlate with the severity of DED. Cytokine levels in tears will be evaluated using Human Immunotherapy Luminex® Performance Assay 25-plex Fixed Panel System.

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Assessment of central corneal sensitivity

  Measured using Cochet-Bonnet aesthesiometer (Luneau; Pruneay-Le-Gillon, France).

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

Secondary Outcomes (5)

• Evaluation of potential pain biomarkers in patients' saliva

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Dry Eye Questionnaire-5 (DEQ5) 5-item

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Ocular surface disease index (OSDI)

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Visual function (VFQ-25) questionnaire

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

• Visual acuity evaluation (LogMAR)

  7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

Study Arms (2)

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.

Device: Artificial tears (sodium hyaluronate 0.2%)

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.

Interventions

Artificial tears (sodium hyaluronate 0.2%) 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 be using artificial tears before and after cataract surgery

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Santen Oy: collaborator

Study Sites (1)

Lithuanian University of Health Sciences

Kaunas, LT-44307, Lithuania

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Cataract

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Lens Diseases

Central Study Contacts

Reda Zemaitiene

CONTACT

+37037327064; reda.zemaitiene@lsmuni.lt

Laura Kapitanovaite

CONTACT

+37037327064; laura.kapitanovaite@kaunoklinikos.lt

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of the Department of Ophthalmology at the Lithuanian University of Health Sciences

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 7, 2024
• Study Start: March 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

LI (1)