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Completed

NCT Number: NCT04663529

Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers

This study aims to analyze the changes of corneal nerve morphology and function in contact lens-related dry eye(CLADE) patients and further discuss the role of corneal nerve in the genesis and development of CLADE.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

33 daily disposable soft contact lens wearers with dry eye disease(DED), 33 DED without contact lens wear and 33 normal control subjects will be involved in study. One experienced ophthalmologist will evaluate the DED symptoms and signs, which include ocular surface disease index(OSDI), tear film breakup time(TBUT), Schirmer Ⅰ test, corneal fluorescein staining, lissamine green staining and meibomian gland dropout rate. After evaluating, corneal sensitivity are measured using a Cochet-Bonnet aesthesiometer. Corneal nerve morphology will be assessed in the right eye using in vivo confocal microscopy(IVCM). Fifteen to twenty minutes after IVCM, 20μL of basal tears will be collected from the inferior meniscus of each participant to test tear neuropeptides. Then investigators analyse the correlation of corneal nerve changes and DED symptoms and signs.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age 18years to 40 years;
  • Male or female DED patients based on Chinese Dry Eye Diagnosis Standard (2020) with or without contact lens wear;
  • Provision of written informed consent.

Exclusion criteria

  • Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, ocular surgical history, laser treatment in the last 3 months, Meibomian function (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
  • Pregnant and lactating women, or those planning a pregnancy over the course of the study
  • Uncontrolled systemic disease
  • Suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

Treatment and study plan

contact lens

Other

daily disposable soft contact lens

Primary outcomes

  1. sub-basal corneal nerve density

    Time frame: baseline

    Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve fiber density will be calculated from a manual trace of the length of all nerve fibers in each 1 mm2 image.

  2. sub-basal corneal nerve tortuosity

    Time frame: baseline

    Sub-basal corneal nerve plexus image will be acquired using a laser scanning confocal microscope. Sub-basal nerve tortuosity will be assessed using a grading scale separately by two experienced ophthamologist.

Secondary outcomes

  1. ocular surface disease index(OSDI)

    Time frame: baseline

    OSDI is one of the most frequently used questionnaires for evaluation of DED. This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100.

  2. Tear break-up time (TBUT)

    Time frame: baseline

    TBUT is the time from normal blinking to the first appearance of a break in the tear film.

  3. Schirmer Ⅰ test (SⅠt)

    Time frame: baseline

    The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters.

  4. Corneal fluorescein staining

    Time frame: baseline

    The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior).

  5. Lissamine green staning

    Time frame: baseline

    To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded.

  6. meibomian gland droupout rate

    Time frame: baseline

    meibomian gland evaluation

  7. corneal sensitivity

    Time frame: baseline

    Corneal sensitivity will be measured in the right eye only using the Cochet-Bonnet aesthesiometer and the ascending method of limits to determine the threshold of stimulus detection.

  8. the concentration of substance P

    Time frame: baseline

    20μL of basal tears will be collected from the inferior meniscus of each subject to test substance P. Substance P levels will be quantified by competitive enzyme-linked immunosorbent assays.

  9. the concentration of CGRP

    Time frame: baseline

    CGRP levels will be quantified by competitive enzyme-linked immunosorbent assays.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Jun 1, 2022

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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