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

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ClinicalTrials.gov Identifier: NCT04663529
Recruitment Status : Not yet recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Contact Lens Complication Dry Eye Other: contact lens

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 99 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
CLADE
contact lens wearers with DED
 Other: contact lens
daily disposable soft contact lens
non-CLADE
DED without contact lens wear
NC
normal control


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
tear

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
DED patients from Peking University Third Hospital
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663529


Contacts
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Contact: Qi hong 010-13901066889 doctorqihong@163.com
Contact: YANG tingting 010-19801162161 ytt98620@163.com

Sponsors and Collaborators
Peking University Third Hospital
More Information
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04663529    
Other Study ID Numbers: CLADE
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking University Third Hospital:
contact lens
tear film
dry eye
corneal sub-basal nerve
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases