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

Not Applicable

Completed

• Conditions: Tinted Contact Lense
• Interventions: Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea; Device: EyeLIKe Shine, Koryo Eyetech Co

• Registration Number: NCT02537275
• Lead Sponsor: Yonsei University

Brief Summary

Investigators planned to investigate changes in visual function after wearing decorative tinted soft contact lenses with different pigment-free optical zone diameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-01
• Last Update Posted: 2015-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• normal subject
• aged above 20 years old

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
wearing contact lense group	EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea	normal subjects after wearing tinted/normal contact lenses
wearing contact lense group	EyeLIKe Shine, Koryo Eyetech Co	normal subjects after wearing tinted/normal contact lenses

Primary Outcome Measures

Name	Time	Method
score of best-corrected visual acuity (BCVA)	1 day

Secondary Outcome Measures

Name	Time	Method
Total score of ocular higher-order aberrations	1 day	ocular higher-order aberrations measured by iTrace (Tracey Technologies, Houston, Texas, USA; software V.4.1.0)
contrast sensitivity with tinted lense	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).

Trial Locations

Locations (1)

Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of