CClinicalTrials.gg
Status unknownNCT05273606Updated Dec 28, 2022

Short-term Clinical Performance of Multifocal Soft Contact Lens

An interventional study of MiSight mutifocal soft contact lens and Proclear 1 Day soft contact lens in Myopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-12-28.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
8 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's planned enrollment of 40 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

    • Prior to being considered eligible to participate in this study, each subject MUST:

      1. Be between 8 and 12 years of age inclusive at the baseline examination.
      2. Have:

        1. read the Informed Assent,
        2. been given an explanation of the Informed Assent,
        3. indicated an understanding of the Informed Assent and
        4. signed the Informed Assent Form.
      3. Have their parent or legal guardian:

        1. read the Informed Consent,
        2. been given an explanation of the Informed Consent,
        3. indicated an understanding of the Informed Consent and
        4. signed the Informed Consent Form.
      4. 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.
      5. 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.
      6. 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.)
      7. Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:

        1. Spherical refractive error: between -0.75 and -4.00 D inclusive,
        2. Astigmatism: ≤-0.75 D,
        3. Anisometropia: ≤1.50D,
      8. Best-corrected visual acuity :≥0.8.

Exclusion criteria

Exclusion Criteria:

    • Subjects may not be considered eligible if ANY of the following apply:

      1. Subject has regular use of ocular medications.
      2. 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.
      3. A history of ocular trauma or ocular surgery in the last 8 weeks.
      4. Subject has worn rigid gas permeable contact lenses in the last 6 weeks, including orthokeratology lenses.
      5. Abnormal secretion or excretion of tear fluid, infection of the tear ducts, or other recurrent ocular infections.
      6. A known allergy to fluorescein, benoxinate, proparacaine, or tropicamide.
      7. Keratoconus or an irregular cornea.
      8. 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.
      9. Strabismus, amblyopia patients, only one eye meets the admission conditions.
      10. Subjects have received any myopia control treatment.
      11. Subject is currently an active participant in another clinical study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    one group for contact lens

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

Interventions

  • DeviceMiSight mutifocal soft contact lens

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

  • DeviceProclear 1 Day soft contact lens

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

06

What researchers measure

Primary outcomes

  1. 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

  1. Patients' subjective acceptability to multifocal soft contact lens

    The patients will be asked to complete questionnaires at each visit regarding vision, lens comfort, the difficulty of lens insert and removal, etc. of the multifocal contact lens.

    Time frame: Proclear baseline; Misight baseline; 1 week; 1month

  2. Doctors' clinical evaluation to multifocal soft contact lens

    The doctors will be asked to complete questionnaires regarding the difficulty of fitting procedure and general impression of the multifocal contact lens.

    Time frame: Proclear baseline; Misight baseline; 1 week; 1month

  3. Change in the contact lens corrected visual acuity relative to baseline

    Patients will wear contact lens when they are tested

    Time frame: Proclear baseline;Misight baseline;1 week;1month

07

Study locations

1 site
  • Zhongshan Ophthalmic Center, Sun Yat-sen University
    Guangzhou, Guangdong 510060, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05273606
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Xiao Yang (Principal Investigator, Clinical Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Mar 10, 2022
Start date
Jul 16, 2022
Primary completion
Dec 13, 2022
Completion
Dec 16, 2022 (estimated)
Last update
Dec 28, 2022

Study contacts

Xiao Yang, PhD
study chair · Zhongshan Ophthalmic Center, Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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