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Extended Depth of Focus Contact Lenses for Presbyopia

NCT ID: NCT05495971

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-05-12

Brief Summary

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VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.

Detailed Description

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This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.

Conditions

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Presbyopia

Keywords

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soft contact lens

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects will serve as their own control using objective baseline data.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Presbyopia

Subject's baseline vision will be compared with vision wearing treatment product

Group Type EXPERIMENTAL

NaturalVue Multifocal

Intervention Type DEVICE

EDOF

Interventions

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NaturalVue Multifocal

EDOF

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Suitable and able to wear contact lenses
* Normal best corrected vision (20/25 or better)
* Need reading add +2.00 or stronger

Exclusion Criteria

* Pre-existing ocular condition that would contraindicating lens wear
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Visioneering Technologies, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Douglas P. Benoit, OD

Role: STUDY_DIRECTOR

Visioneering Technologies, Inc

Locations

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VTI

Alpharetta, Georgia, United States

Site Status

Countries

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United States

References

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Tuan KA, Benoit DP, O'Connor B. Evaluation of the Functional Visual Range of a Catenary Curve-Based, Extended Depth-of-Focus Contact Lens for Presbyopia. Clin Ophthalmol. 2024 Jul 19;18:2113-2123. doi: 10.2147/OPTH.S468699. eCollection 2024.

Reference Type DERIVED
PMID: 39055378 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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VTI-2206

Identifier Type: -

Identifier Source: org_study_id