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

Completed

• Conditions: Dry Eye; Contact Lens Complication
• Interventions: Other: contact lens

• Registration Number: NCT04663529
• Lead Sponsor: 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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study Start: 2020-10-01
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Primary Completion: 2021-05-01
• Study Completion: 2021-10-01
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CLADE	contact lens	contact lens wearers with DED

Primary Outcome Measures

Name	Time	Method
sub-basal corneal nerve density	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.
sub-basal corneal nerve tortuosity	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

Name	Time	Method
Tear break-up time (TBUT)	baseline	TBUT is the time from normal blinking to the first appearance of a break in the tear film.
meibomian gland droupout rate	baseline	meibomian gland evaluation
Corneal fluorescein staining	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).
ocular surface disease index(OSDI)	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.
Schirmer Ⅰ test (SⅠt)	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.
corneal sensitivity	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.
the concentration of CGRP	baseline	CGRP levels will be quantified by competitive enzyme-linked immunosorbent assays.
Lissamine green staning	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.
the concentration of substance P	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China