ACTIVE_NOT_RECRUITING

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

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Conditions

MyopiaRefractive Error

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-center, randomized, double-masked clinical trial. All study devices are market approved/cleared in the localities where the study is conducted. Subjects will be randomly assigned to wear NaturalVue Sphere single vision contact lenses (SVCL) or NaturalVue Multifocal (NVMF) soft contact lenses for a total of three years.

Official Title

Progressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial

Quick Facts

Study Start:2022-01-22
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05159765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female, aged 7 to \<13 (inclusive) at the Screening/Baseline examination.
  2. 2. Meet the following refractive criteria determined by cycloplegic autorefraction at Screening/Baseline:
  3. * Spherical Equivalent Refractive Error (SERE): between -0.75 and -5.00 D inclusive.
  4. * Astigmatism: ≤ -0.75 D
  5. * Anisometropia: \< 1.000
  1. 1. Has previously worn or currently wears rigid or gas permeable contact lenses, including orthokeratology lenses,
  2. 2. Appears to exhibit poor personal hygiene, that, in the Investigator's opinion, might prevent safe contact lens wear.
  3. 3. Is currently, or within 30 days prior to this study has been, an active participant in another clinical study.
  4. 4. Current or prior use of bifocals, progressive addition lenses, atropine, pirenzepine, multifocal or specialized contact lenses, or ANY other myopia control treatment.
  5. 5. The Investigator for any reason considers that it is not in the best interest of the subject to participate in the study, including if the child is not mature enough to independently handle and care for soft contact lenses.

Contacts and Locations

Principal Investigator

Ashley Tuan, OD, PhD
STUDY_CHAIR
VTI

Study Locations (Sites)

Fig Garden Optometry
Fresno, California, 93704
United States
North Suburban Vision Consultants
Deerfield, Illinois, 60015
United States
Cooper Eye Care
New York, New York, 10065
United States
Bellaire Family Eye Care
Bellaire, Texas, 77401
United States

Collaborators and Investigators

Sponsor: Visioneering Technologies, Inc

  • Ashley Tuan, OD, PhD, STUDY_CHAIR, VTI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-22
Study Completion Date2026-02

Study Record Updates

Study Start Date2022-01-22
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Myopia
  • Refractive Error

Additional Relevant MeSH Terms

  • Myopia