The Pattern of Dry Eye Disease After Cataract Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Ocular Surface Disease; Dry Eye Disease
• Intervention / Treatment: Device: Artificial tears (sodium hyaluronate 0.2%)

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Reda Zemaitiene; Phone Number: +37037327064; Email: reda.zemaitiene@lsmuni.lt
• Study Contact Backup: Name: Laura Kapitanovaite; Phone Number: +37037327064; Email: laura.kapitanovaite@kaunoklinikos.lt

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-44307
    • Recruiting
    • Lithuanian University of Health Sciences
    • Contact: Reda Zemaitiene; Phone Number: + 370 37 327 201; Email: rektoratas@lsmu.lt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of potential pain biomarkers in patients' saliva	Pain biomarkers which will be evaluated - soluble tumor necrosis factor-α receptor II (sTNFαRII), nerve growth factor (NGF), brain-derived neurotrophic factor (BDNF), secretory IgA (SIgA). Pain is a common complaint in both dry eye disease (DED) and post-cataract surgery. Pain biomarkers will be evaluated using ELISA methods.	7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Dry Eye Questionnaire-5 (DEQ5) 5-item	The DEQ-5 consists of five questions that assess the following: frequency of watery eye, discomfort, and dryness (scored on a 0-4 scale) and late day discomfort and dryness intensity (scored on a 0 -5 scale).	7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Ocular surface disease index (OSDI)	OSDI is a 12-item questionnaire that assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time.	7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual function (VFQ-25) questionnaire	The 25-item questionnaire has several subscale categories that assesses different aspects of health-related quality of life including overall health, overall vision, difficulty with near vision, difficulty with distance vision, limitations in social functioning due to vision, role limitations due to vision, dependency on others due to vision, mental health symptoms due to vision, future expectations for vision, driving difficulties, and pain and discomfort around the eyes	7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Visual acuity evaluation (LogMAR)	Mean change from baseline.	7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Collaborators: Santen Oy

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid; Lubricant Eye Drops
• Other Study ID Numbers: SASKAT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If it is necessary (at the motivated request of the customer) to transfer data to the research customer or third parties, only depersonalised data will be transferred, but data transfer to third parties is not foreseen.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No