Effect of the Pigment-free Optical Zone Diameter of Decorative Tinted Soft Contact Lenses on Visual Function

August 31, 2015 updated by: Yonsei University
Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 102-752
        • Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal subject
  • aged above 20 years old

Exclusion Criteria:

  • subject who had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease,
  • patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: wearing contact lense group
normal subjects after wearing tinted/normal contact lenses
Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea
tinted contact lens, daily-wear tinted lens
Device: EyeLIKe Shine, Koryo Eyetech Co
clear lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
score of best-corrected visual acuity (BCVA)
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score of ocular higher-order aberrations
Time Frame: 1 day
ocular higher-order aberrations measured by iTrace (Tracey Technologies, Houston, Texas, USA; software V.4.1.0)
1 day
contrast sensitivity with tinted lense
Time Frame: 1 day
contrast sensitivity measured by Optec 6500 test system (Stereo Optical Co, Chicago, Illinois, USA) at five spatial frequencies (1.5, 3, 6, 12 and 18 cycles/degree (cpd)) under photopic (luminance value of 85 candelas/square metre (cd/m2)) and mesopic conditions (target luminance value of 3 cd/m2) with or without glare after wearing clear lens and tinted lenses with different pigment-free optical zone diameters (4, 5 and 6 mm).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 1-2014-0024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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