Color lens design for normal subjects

JRCT ID: jRCTs032230502

Registered date:11/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 11/12/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

For two types of optotypes (dark optotypes on a light background, bright optotypes on a dark background), look at up to 50 optotypes with different contrasts on a background of about 10 types of brightness in order, answer the direction, and visually recognize them to calculate the threshold curve.
After that, the influence of the interfering light and the effect of the spectral characteristics are measured while changing the index and the background luminance to create a colored lens.
Finally, wear the prepared tinted lenses and measure the contrast visual acuity of each.

Outcome(s)

• Primary Outcome: Concordance rate between the magnitude of the theoretically calculated value and the magnitude of contrast sensitivity measured by wearing a prototype lens based on the calculation

Secondary Outcome

1) Statistically significant difference in contrast sensitivity measured by wearing a lens with a large theoretical calculation value and a lens with a small theoretical calculation value
2) Visibility threshold curve (minimum and maximum brightness and their contrast values, minimum contrast values and their brightness, fitting function)
3) Chromaticity and luminance of inspection results

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

Patients who meet all of the following conditions are eligible.
1) Subjects aged 20 to 65 at the time of obtaining consent.
2) Subjects with corrected decimal visual acuity of 1.0 or more.
3) Subjects with no abnormalities in slit-lamp examination and fundus examination, and no other ocular abnormalities that cause photophobia.
4) Subjects who have given written informed consent of the patient's own free will with sufficient understanding after receiving a sufficient explanation for participation in this study.

Exclude criteria

1) Those diagnosed with Irlen's syndrome.
2) Subjects who are judged inappropriate for participation in this study by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Miura Gen
• Source(s) of Monetary Support: Mitui Chemicals, Inc.