Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear

NCT ID: NCT02894489

Last Updated: 2016-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

Brief Summary

Our study is aimed to observe the long termed effect of contact lens wear on ocular surface, especially focused on visual function and ocular inflammation mediators.

Detailed Description

Contact lens fitting are important treatments for many ocular diseases as they provide three main therapeutic applications: visual correction, protection of ocular surface, and cosmetic or sport purposes. The ophthalmology department of NTUH has set up contact lens special clinic as one of our comprehensive refractive services. The investigators provided corneal lenses or Rose K lenses for optical correction of keratoconus patients; the investigators also fitted large scleral lenses for the correction of irregular astigmatism for post-penetrating keratoplasty and post-refractive surgery patients. In addition, contact lenses can be an adjuvant therapy for ocular surface disorders as severe dry eye and limbal insufficiency. There were researches that proved the inflammatory mediators and neutrophils increased after long-termed wear of silicon hydrogel soft lenses or over night orthokeratology lenses. They also concluded that lens wear affected corneal epithelial proliferation. However, the physiological changes after long-termed wear of large diameter scleral lenses are still pending. In addition, we still do not understand the lens effects on high order aberration and ocular surface structures. The purpose of our study is to analyze the epidemiologic data and treatment results of the patients fitted with specialty lenses in our contact lens clinic from Aug 2016 to Aug 2018. Patients will be categorized into different groups by the diagnoses and the type of lens wear. After 6 months of follow up, the change of visual acuity, visual function related quality of life, the changes of ocular surface structures and physiology will be analyzed. The investigators hope to share the experiences of specialty contact lens fitting and understand the effects of long-term contact lens wear on ocular surface.

Conditions

Ocular Surface Disease; Keratoconus; Irregular Astigmatism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

corneal lenses

patients that wear corneal lenses ( Hiclear Rigid Gas Permeable Lenses)

Group Type: EXPERIMENTAL

corneal lenses

Intervention Type: DEVICE

wear corneal lenses on daily basis

large diameter lenses

patients that wear scleral lenses (Paragon Normaleyes)

Group Type: EXPERIMENTAL

large diameter lenses

Intervention Type: DEVICE

Interventions

corneal lenses

wear corneal lenses on daily basis

Intervention Type: DEVICE

large diameter lenses

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age 20 to 65
• contact lens wear
• willing to be followed for at least 6 months

Exclusion Criteria

• active ocular infection
• active corneal melting
• inability to follow lens cleaning instructions
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hsiao Sang Chu, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsiao Sang Chu, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, NTUH

Locations

Hsiao Sang Chu

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hsiao Sang Chu, MD, MS

Role: CONTACT

einahpets18@gmail.com

+886-2-23123456 ext. 63804

Facility Contacts

Hsiao Sang Chu, MD, MS

Role: primary

einahpets18@gmail.com

928980736

Other Identifiers

201508075RINC

Identifier Type: -

Identifier Source: org_study_id