MedDataX Logo

Customizing Myopia Control With Multifocal Toric Contact Lens

NCT ID: NCT04352868

Last Updated: 2020-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will evaluate the ability of toric multifocal contact lens to reduce the change of myopia progression in children (aged 8-12) with myopic astigmatism.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to assess if a center distance toric multifocal contact lenses can slow the amount of change of myopia progression in children with myopia plus astigmatism. Multifocal contact lenses have been theorized to influence the peripheral optics of the eye such that they slow the rate of myopia progression in nearsighted children. This outcome is yet to be evaluated in children with myopia plus astigmatism.The secondary outcome is to measure the change in peripheral optics caused by the contact lens. This information is key to understanding the mechanism of multifocal contact lens optics on the eye. Ultimately this information would be used to create a software that can estimate the effect of multifocal contact lenses on the peripheral optics of the child's eye. This software can potentially be used by practitioners worldwide to better customize multifocal contact lenses to slow myopia progression.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractive Errors Myopia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Myopia Multifocal contact lens Refractive error Myopia treatment Myopia control Myopia management

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Toric soft contact lens

Toric soft contact lens

Group Type ACTIVE_COMPARATOR

Intelliwave toric, soft contact lens

Intervention Type DEVICE

This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Multifocal toric soft contact lens

A multifocal toric soft contact lens with a +2.00 D add.

Group Type EXPERIMENTAL

Intelliwave multifocal, toric, soft contact lens

Intervention Type DEVICE

This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intelliwave multifocal, toric, soft contact lens

This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Intervention Type DEVICE

Intelliwave toric, soft contact lens

This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 8 to 12 years, inclusive, at baseline examination
* -0.50 to -6.00 D, inclusive, spherical component, cycloplegic autorefraction
* ≥0.75 DC, cycloplegic autorefraction
* 0.1 logMAR or better best-corrected visual acuity in each eye

Exclusion Criteria

* Eye disease or refractive error conditions (e.g., keratoconus, retinal abnormalities, retinopathy of prematurity, etc.)
* Ocular surgery, severe ocular trauma, active ocular infection or inflammation
* Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Andrew Pucker

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew D Pucker, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-300004596

Identifier Type: -

Identifier Source: org_study_id