A Clinical Study of Short-term Clinical Performance of Multifocal Soft Contact Lens

Zhongshan Ophthalmic Center, Sun Yat-sen University1 site in 1 country40 target enrollmentJuly 16, 2022

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment: 40
Locations: 1
Primary Endpoint: Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is aimed to observe the short-term clinical performance of MiSight™ multifocal soft contact lens compared with Proclear™ 1day, including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses.

Detailed Description

Compared with Proclear™ 1day, observe the short-term clinical performance of MiSight™ multifocal soft contact lens including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses in 1 month.

Registry

clinicaltrials.gov

Start Date

July 16, 2022

End Date

December 16, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party

Principal Investigator

Xiao Yang

Principal Investigator, Clinical Professor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•• Prior to being considered eligible to participate in this study, each subject MUST:
•Be between 8 and 12 years of age inclusive at the baseline examination.
•read the Informed Assent,
•been given an explanation of the Informed Assent,
•indicated an understanding of the Informed Assent and
•signed the Informed Assent Form.
•Have their parent or legal guardian:
•read the Informed Consent,
•been given an explanation of the Informed Consent,
•indicated an understanding of the Informed Consent and

Exclusion Criteria

•• Subjects may not be considered eligible if ANY of the following apply:
•Subject has regular use of ocular medications.
•Any systemic disease which is not suggested to wear contact lens or current use of systemic medications which may significantly affect contact lens wear, visual function, or refractive state.
•A history of ocular trauma or ocular surgery in the last 8 weeks.
•Subject has worn rigid gas permeable contact lenses in the last 6 weeks, including orthokeratology lenses.
•Abnormal secretion or excretion of tear fluid, infection of the tear ducts, or other recurrent ocular infections.
•A known allergy to fluorescein, benoxinate, proparacaine, or tropicamide.
•Keratoconus or an irregular cornea.
•Subjects who have been in a special environment such as dryness, serious dust, or volatile chemicals for a long time affect the wear of contact lenses.
•Strabismus, amblyopia patients, only one eye meets the admission conditions.

Outcomes

Primary Outcomes

Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month

Time Frame: Proclear baseline;VMisight baseline; 1 week; 1month

Secondary Outcomes

Doctors' clinical evaluation to multifocal soft contact lens(Proclear baseline; Misight baseline; 1 week; 1month)
Change in the contact lens corrected visual acuity relative to baseline(Proclear baseline;Misight baseline；1 week;1month)
Patients' subjective acceptability to multifocal soft contact lens(Proclear baseline; Misight baseline; 1 week; 1month)