ACTIVE_NOT_RECRUITING

Visual Performance of Center Distance Daily Disposable Multifocal Lenses

Conditions

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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

The purpose of this study is to compare visual performance (high and low contrast acuity, reading acuity, contrast sensitivity, stereoacuity, accommodative response, eye hand coordination, far near vision, and dynamic vision) between Visioneering Technologies, Inc. NaturalVue Multifocal and CooperVivion MiSight.

Official Title

Visual Performance of Center Distance Daily Disposable Multifocal Lenses

Quick Facts

Study Start:2024-07-31

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06475053

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:9 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Participants must satisfy the following conditions for inclusion in the trial: * Be between 9 and 30 years of age * Sign written Informed Consent/Assent. * Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D * 20/20 vision in each eye * Existing contact lens wearer * An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available) * No known ocular disease - anterior or posterior (posterior determined by history/chart) * Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study. * On examination, have ocular findings considered to be within normal limits. * Be willing and able to follow instructions and attend the schedule of follow-up visits.	* Any of the following will exclude a participant from this trial: * Current hard lens wearers * Using eye medication contraindicating lens wear such as daily use of artificial tears. * Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial. * History of corneal refractive surgery * Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial. * Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions. * Allergy or sensitivity to any product used in this trial. * Pre-existing ocular condition that would contraindicate lens wear. * Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses. * Lazy eye (Strabismus or amblyopia) * Pupil size \< 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )

Inclusion Criteria

Exclusion Criteria

* Participants must satisfy the following conditions for inclusion in the trial:
* Be between 9 and 30 years of age
* Sign written Informed Consent/Assent.
* Spherical Equivalent glasses prescription: -0.50 to -7.00 diopters (D), Astigmatism: ≤ -0.75D, Anisometropia: ≤ 1.00D
* 20/20 vision in each eye
* Existing contact lens wearer
* An eye exam in last 9 months, normal stereoacuity on prior chart (or test if not available)
* No known ocular disease - anterior or posterior (posterior determined by history/chart)
* Have an acceptable or optimal fit with test lenses and be willing to wear these lenses as directed for the duration of the study.
* On examination, have ocular findings considered to be within normal limits.
* Be willing and able to follow instructions and attend the schedule of follow-up visits.

* Any of the following will exclude a participant from this trial:
* Current hard lens wearers
* Using eye medication contraindicating lens wear such as daily use of artificial tears.
* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* History of corneal refractive surgery
* Currently enrolled in an ophthalmic clinical trial that could negatively impact corneal or conjunctival health in this trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Allergy or sensitivity to any product used in this trial.
* Pre-existing ocular condition that would contraindicate lens wear.
* Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye or be exaggerated by wearing contact lenses.
* Lazy eye (Strabismus or amblyopia)
* Pupil size \< 3.00 mm in either eye in dim light (measured at approximately 10 cd/m2 )

Contacts and Locations

Principal Investigator

Marjean T Kulp, OD, MS

PRINCIPAL_INVESTIGATOR

The Ohio State University College of Optometry

Study Locations (Sites)

The Ohio State University College of Optometry

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Visioneering Technologies, Inc

Marjean T Kulp, OD, MS, PRINCIPAL_INVESTIGATOR, The Ohio State University College of Optometry

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 Date2024-07-31

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-07-31

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Contact lens
Multifocal

Additional Relevant MeSH Terms

Myopia