Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear
Primary Purpose
Ocular Surface Disease, Keratoconus, Irregular Astigmatism
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
corneal lenses
large diameter lenses
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Surface Disease
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
Sites / Locations
- Hsiao Sang ChuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
corneal lenses
large diameter lenses
Arm Description
patients that wear corneal lenses ( Hiclear Rigid Gas Permeable Lenses)
patients that wear scleral lenses (Paragon Normaleyes)
Outcomes
Primary Outcome Measures
Ocular inflammatory mediators
to monitor the change of tear inflammatory mediators 6 months after lens wear
Secondary Outcome Measures
Full Information
NCT ID
NCT02894489
First Posted
August 30, 2016
Last Updated
September 8, 2016
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02894489
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Surface Disease, Keratoconus, Irregular Astigmatism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
corneal lenses
Arm Type
Experimental
Arm Description
patients that wear corneal lenses ( Hiclear Rigid Gas Permeable Lenses)
Arm Title
large diameter lenses
Arm Type
Experimental
Arm Description
patients that wear scleral lenses (Paragon Normaleyes)
Intervention Type
Device
Intervention Name(s)
corneal lenses
Intervention Description
wear corneal lenses on daily basis
Intervention Type
Device
Intervention Name(s)
large diameter lenses
Primary Outcome Measure Information:
Title
Ocular inflammatory mediators
Description
to monitor the change of tear inflammatory mediators 6 months after lens wear
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiao Sang Chu, MD, MS
Phone
+886-2-23123456
Ext
63804
Email
einahpets18@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao Sang Chu, MD, MS
Organizational Affiliation
Department of Ophthalmology, NTUH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hsiao Sang Chu
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiao Sang Chu, MD, MS
Phone
928980736
Email
einahpets18@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
for publication
Learn more about this trial
Changes of Visual Function, Ocular Surface Structures and Physiology After Long-Termed Contact Lens Wear
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