Short-term Clinical Performance of Multifocal Soft Contact Lens

NCT05273606 | Unknown

• 1 other identifier: 2021KYPJ202
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

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

  Proclear baseline;VMisight baseline; 1 week; 1month

Secondary Outcomes (3)

• Patients' subjective acceptability to multifocal soft contact lens

  Proclear baseline; Misight baseline; 1 week; 1month

• 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

Study Arms (1)

Experimental Group

EXPERIMENTAL

one group for contact lens

Device: MiSight mutifocal soft contact lens; Device: Proclear 1 Day soft contact lens

Interventions

MiSight mutifocal soft contact lens DEVICE

Subjects will wear MiSight™ multifocal soft contact lenses for 1 month.

Experimental Group

Proclear 1 Day soft contact lens DEVICE

Proclear™ 1 Day soft contact lens will be worn for baseline evaluation.

Experimental Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Have:
• 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
• signed the Informed Consent Form.
• Along with their parent or guardian, be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
• Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
• Agree to wear the assigned contact lenses for the duration of the 1-month study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)

You may not qualify if:

• 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.
• Subjects have received any myopia control treatment.
• Subject is currently an active participant in another clinical study.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Xiao Yang, PhD

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 10, 2022
• Study Start: July 16, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 16, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)