Accommodative Behaviors in Multifocal Contact Lenses

NCT06064617 | Completed Results FDA Device

• 1 other identifier: 2023H0080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Addition lenses are often used to treat a range of eye conditions. Addition lenses are specifically used to help patients who do not have the ability to focus their eyes to see clearly up close. Eye focusing is called accommodation. Addition lenses are easy to prescribe in a pair of glasses and are often called the bifocal portion of the glasses. Addition lenses can be used for adults who have presbyopia (they cannot read up close without the aide of a bifocal) and for patients of all ages who have eye focusing problems (e.g. accommodative insufficiency, accommodative infacility, accommodative dysfunction). Addition powers can also be put into contact lenses. Contact lenses that have addition powers in them are called multifocal contact lenses. These are often marketed for patients that are 40 and over who have presbyopia, and are prescribed to help patients see up close as well as far away in their contact lenses. Multifocal contact lenses are also used in children with nearsightedness because studies have shown that some multifocal designs can slow down the progression of nearsightedness. As stated before, addition lenses can be used to treat eye focusing problems in patients of all ages, before presbyopia. What is unclear is whether the addition power in contact lenses has the same treatment effect as an addition power in a pair of glasses when they are being used to treat eye focusing problems. This study will assess how different kinds of multifocal contact lenses (center distance or center near) will change eye focusing and eye teaming in young adult patients.

Conditions

Accommodation Disorder

Outcome Measures

Primary Outcomes (1)

• Objective Accommodative Response (in Diopters) on the Grand Seiko Autorefractor at 2.5 Diopters (40 cm)

  Accommodative function will be compared using the Grand Seiko Autorefractor between the center distance and center near group. The instrument will record the patient's refractive error at near (40 cm), which is commonly used for near assessment in clinic. Patients place their head on a chin rest and look at targets at different distances. The examiner then pushes a button and the refractive error (in Diopters) is recorded from the instrument and placed in an excel file to be analyzed.

  Up to two hours (1 hour in each lens)

Secondary Outcomes (5)

• Accommodation (in Diopters) Measured by Monocular Estimation Method (MEM)

  Up to two hours

• Accommodation (in Diopters) Measured by Monocular Push-Up

  Up to 2 hours

• Accommodation (in Cycles Per Minute) Measured by Accommodative Facility

  Up to 2 hours

• Phoria (in Prism Diopters) Measured by Modified Thorington at Distance

  Up to 2 Hours

• Phoria (in Prism Diopters) Measured by Modified Thorington at Near

  Up to 2 hours

Study Arms (2)

Center Distance then Center Near Multifocal Contact Lens

EXPERIMENTAL

All participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained. Then participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained.

Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens; Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens

Center Near then Center Distance Multifocal Contact Lens

EXPERIMENTAL

All participants will wear a Biofinity center near multifocal contact lens with a +2.50 add and measurements will be obtained. Then all participants will wear a Biofinity center distance multifocal contact lens with a +2.50 add and measurements will be obtained.

Device: Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens; Device: Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens

Interventions

Center-Near (+2.50D) Coopervision Biofinity Multifocal Contact Lens DEVICE

Center-Near multifocal design

Center Distance then Center Near Multifocal Contact Lens; Center Near then Center Distance Multifocal Contact Lens

Center Distance (+2.50 D) Coopervision Biofinity Multifocal Contact Lens DEVICE

Center-Distance multifocal design

Center Distance then Center Near Multifocal Contact Lens; Center Near then Center Distance Multifocal Contact Lens

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18 to ≤ 30 years old
• Acuity of 20/25 or better in both eyes with habitual contact lens prescription
• No history of ocular disease or active ocular inflammation
• No history of ocular or refractive surgery
• No current history of rigid contact lens wear
• Astigmatism ≤1.00 D
• Free of binocular vision disorder (strabismus, amblyopia, vergence dysfunction, accommodative dysfunction)

You may not qualify if:

• No prior or concurrent participation in myopia control or use of low dose atropine, multifocal contact lenses
• No use of any medications suspected to affect accommodation

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Limitations and Caveats

The participants were not allowed to adapt to the contact lenses outside of the office - all testing was done in office and participants were not allowed to take the contact lenses out of the office.

Results Point of Contact

• Title: Ann Morrison
• Organization: The Ohio State University

morrison.421@osu.edu

614-247-0010

Study Officials

• Ann M Morrison, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know what lens they are in
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will be an observational single-center investigation using a cross sectional design and each subject will undergo two test sessions and will wear two different contact lenses. Each test session will take approximately 2 hours. The two arms are as follow: * Center-Distance (+2.50D add) then Center-Near (+2.50D add) * Center-Near (+2.50D add) then Center-Distance (+2.50D add)

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: October 3, 2023
• Study Start: November 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: January 8, 2026
• Results First Posted: January 8, 2026

Record last verified: 2026-01

Locations

US (1)