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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02894489
Collaborator
(none)
40
1
2
36
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: corneal lenses
  • Device: large diameter lenses
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: corneal lenses

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

Device: corneal lenses
wear corneal lenses on daily basis

Experimental: large diameter lenses

patients that wear scleral lenses (Paragon Normaleyes)

Device: large diameter lenses

Outcome Measures

Primary Outcome Measures

  1. Ocular inflammatory mediators [6 months]

    to monitor the change of tear inflammatory mediators 6 months after lens wear

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hsiao Sang Chu Taipei Taiwan 10002

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hsiao Sang Chu, MD, Principal Investigator, National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02894489
Other Study ID Numbers:
  • 201508075RINC
First Posted:
Sep 9, 2016
Last Update Posted:
Sep 9, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 9, 2016