Clinical trial NCT04663529: Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
Official title: Correlation Study of Corneal Nerve Changes and Dry Eye in Contact Lens Wearers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Lens Complication
Dry Eye
Keywords: contact lens
tear film
dry eye
corneal sub-basal nerve
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DED patients from Peking University Third Hospital

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.

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.

Eligibility 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.

Primary outcomes:
measure: sub-basal corneal nerve density
timeFrame: baseline
measure: sub-basal corneal nerve tortuosity
timeFrame: baseline
Secondary outcomes:
measure: ocular surface disease index(OSDI)
timeFrame: baseline
measure: Tear break-up time (TBUT)
timeFrame: baseline
measure: Schirmer Ⅰ test (SⅠt)
timeFrame: baseline
measure: Corneal fluorescein staining
timeFrame: baseline
measure: Lissamine green staning
timeFrame: baseline
measure: meibomian gland droupout rate
timeFrame: baseline
measure: corneal sensitivity
timeFrame: baseline
measure: the concentration of substance P
timeFrame: baseline
measure: the concentration of CGRP
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: