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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02537275
Enrollment
30
Registered
2015-09-01
Start date
2014-06-30
Completion date
2015-06-30
Last updated
2015-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinted Contact Lense

Brief summary

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

Interventions

DEVICEEyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea

tinted contact lens, daily-wear tinted lens

DEVICEEyeLIKe Shine, Koryo Eyetech Co

clear lens

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
score of best-corrected visual acuity (BCVA)1 day

Secondary

MeasureTime frameDescription
Total score of ocular higher-order aberrations1 dayocular higher-order aberrations measured by iTrace (Tracey Technologies, Houston, Texas, USA; software V.4.1.0)
contrast sensitivity with tinted lense1 daycontrast 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).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026