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

NCT04663529 | Completed

• 1 other identifier: CLADE
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Contact Lens Complication; Dry Eye

Keywords

contact lens; tear film; dry eye; corneal sub-basal nerve

Outcome Measures

Primary Outcomes (2)

• sub-basal corneal nerve density

  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.

  baseline

• sub-basal corneal nerve tortuosity

  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.

  baseline

Secondary Outcomes (9)

• ocular surface disease index(OSDI)

  baseline

• Tear break-up time (TBUT)

  baseline

• Schirmer Ⅰ test (SⅠt)

  baseline

• Corneal fluorescein staining

  baseline

• Lissamine green staning

  baseline

Study Arms (3)

CLADE

contact lens wearers with DED

Other: contact lens

non-CLADE

DED without contact lens wear

NC

normal control

Interventions

contact lens OTHER

daily disposable soft contact lens

CLADE

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

DED patients from Peking University Third Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

tear

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Contact Lenses

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: December 11, 2020
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 1, 2022

Record last verified: 2020-09

Locations

CN (1)