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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02537275
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tinted Contact Lense	Device: EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea; Device: EyeLIKe Shine, Koryo Eyetech Co	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. score of best-corrected visual acuity (BCVA) [1 day]

Secondary Outcome Measures

1. 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)

2. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine	Seoul		Korea, Republic of	102-752

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02537275
• Other Study ID Numbers: 1-2014-0024
• First Posted: Sep 1, 2015
• Last Update Posted: Sep 1, 2015
• Last Verified: Aug 1, 2015

Study Results

No Results Posted as of Sep 1, 2015