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

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Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Ocular inflammatory mediators


Condition

Ocular Surface Disease

Intervention

corneal lenses

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

August 2016

Completion Date

August 2019

Primary Completion Date

August 2019

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
      

Gender

All

Ages

20 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Hsiao Sang Chu, MD, MS, +886-2-23123456, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT02894489

Organization ID

201508075RINC


Responsible Party

Principal Investigator

Study Sponsor

National Taiwan University Hospital


Study Sponsor

Hsiao Sang Chu, MD, MS, Principal Investigator, Department of Ophthalmology, NTUH


Verification Date

September 2016