NCT02894489

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

3 years

First QC Date

August 30, 2016

Last Update Submit

September 8, 2016

Conditions

Ocular Surface DiseaseKeratoconusIrregular Astigmatism

Outcome Measures

Primary Outcomes (1)

  • Ocular inflammatory mediators

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

    6 months

Study Arms (2)

corneal lenses

EXPERIMENTAL

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

Device: corneal lenses

large diameter lenses

EXPERIMENTAL

patients that wear scleral lenses (Paragon Normaleyes)

Device: large diameter lenses

Interventions

corneal lensesDEVICE

wear corneal lenses on daily basis

corneal lenses
large diameter lensesDEVICE
large diameter lenses

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hsiao Sang Chu

Taipei, Taiwan, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Hsiao Sang Chu, MD, MS

    Department of Ophthalmology, NTUH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao Sang Chu, MD, MS

CONTACT

+886-2-23123456einahpets18@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 30, 2016

First Posted

September 9, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

for publication

Locations

TW(1)