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NCT Number: NCT06298890

The Pattern of Dry Eye Disease After Cataract Surgery

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.

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Key information

Conditions

Dry Eye Disease Cataract Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases Lens Diseases Ocular Surface Disease

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lithuanian University of Health Sciences

Kaunas, LT-44307, Lithuania

Location status: Recruiting

Location contact

Reda Zemaitiene

CONTACT

[email protected]

+ 370 37 327 201

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assessment of ocular surface changes following cataract surgery

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

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

  2. Evaluation of the cornea morphology

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

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

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

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

    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.

  4. Evaluation of tear osmolarity

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

    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.

  5. Evaluation of tear cytokine levels

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

    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.

  6. Assessment of central corneal sensitivity

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

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

Secondary outcomes

  1. Evaluation of potential pain biomarkers in patients' saliva

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

    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.

  2. Dry Eye Questionnaire-5 (DEQ5) 5-item

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

    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).

  3. Ocular surface disease index (OSDI)

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

    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.

  4. Visual function (VFQ-25) questionnaire

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

    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

  5. Visual acuity evaluation (LogMAR)

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

    Mean change from baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Kapitanovaite

CONTACT

[email protected]

+37037327064

Reda Zemaitiene

CONTACT

[email protected]

+37037327064

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Santen Oy

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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