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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894489
• Other study ID #: 201508075RINC
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2016
• Last updated: September 8, 2016
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2016
• Source: National Taiwan University Hospital
• Contact: Hsiao Sang Chu, MD, MS
• Phone: +886-2-23123456
• Email: einahpets18[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism
• Irregular Astigmatism
• Keratoconus
• Ocular Surface Disease

Intervention

Device:
• corneal lenses
wear corneal lenses on daily basis
• large diameter lenses

Locations

Country	Name	City	State
Taiwan	Hsiao Sang Chu	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular inflammatory mediators	to monitor the change of tear inflammatory mediators 6 months after lens wear	6 months	No