Clinical trial NCT05273606: Short-term Clinical Performance of Multifocal Soft Contact Lens
Official title: A Clinical Study of Short-term Clinical Performance of Multifocal Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

* • 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.

Primary outcomes:
measure: Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
timeFrame: Proclear baseline;VMisight baseline; 1 week; 1month
Secondary outcomes:
measure: Patients' subjective acceptability to multifocal soft contact lens
timeFrame: Proclear baseline; Misight baseline; 1 week; 1month
measure: Doctors' clinical evaluation to multifocal soft contact lens
timeFrame: Proclear baseline; Misight baseline; 1 week; 1month
measure: Change in the contact lens corrected visual acuity relative to baseline
timeFrame: Proclear baseline;Misight baseline；1 week;1month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiao Yang, PhD
role: STUDY_CHAIR
References: