Clinical evaluation of hydrogel lenses with water-soluble coating

Not Applicable

Completed

Conditions: Not Applicable

Registration Number: KCT0005526

Lead Sponsor: Seoul National University of Science and Technology

Brief Summary: Contrast sensitivity test showed a significant decrease compared to before wearing in both groups as the wearing period increased in both the photopic vision and mesopic vision, but no difference was observed between the groups. The NIBUT showed a significant decrease according to the increase in wearing period compared to before wearing, and a statistically significant difference was shown between groups after 1 month of wearing. The degree of conjunctival and limbus congestion increased with the increase of the lens wearing period, and the non-coated lenses showed statistically significant changes, but there was no significant difference between groups. In the analysis of the OSDI questionnaire, when wearing non-coated lenses, there was a significant increase in subjective symptoms according to the lapse of the wearing period, but when wearing coated lenses, there was no significant increase between the 3rd and 4th weeks of wearing. In the analysis of the CLDEQ-8 questionnaire, discomfort caused by wearing non-coated lenses tended to be higher at 2 weeks and 4 weeks, but there was no significant difference between wearing time and groups. In the lens parameter analysis, the non-coated lens showed a significant difference from that of the new lens in center thickness, total diameter, radius of curvature, visible light and UV-A, UV-B transmittance. In the case of coated lenses, only the radius of curvature, visible light, and UV-A and UV-B transmittances showed significant differences from the new lenses. The radius of curvature of the lens showed an increase compared to the new lens (8.6mm), the diameter decreased compared to the new lens (14.2mm), but little changed, the central thickness decreased, and there was a significant difference between groups. The visible light transmittance decreased and the UV-A transmittance increased, while the UV-B transmittance decreased compared to the new lens (5%). The amount of protein adhesion was relatively large in the non-coated lens compared to the coated lens, but there was no significant difference. In the observation of the lens surface, the lens before wearing showed a smooth surface and there was no significant difference between the groups, while surface cracking was observed in both lenses after wearing.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 21

Inclusion Criteria

TBUT is measured and selected as a target if both eyes are longer than 5 seconds

Exclusion Criteria

TBUT is measured and one of both eyes is excluded from the subject if it is less than 5 seconds

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Contrast sensitivity test, Hyperemia grade scale, NIBUT(Non-invasive tear break up time);Ocular Surface Disease Index (OSDI);Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

Secondary Outcome Measures