Analysis of Defocus Curve of Pre-Presbyopic and Emerging Presbyopic Patients

NCT ID: NCT04474782

Last Updated: 2021-03-30

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

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-17

Study Completion Date

2020-08-31

Brief Summary

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Educating patients on visual performance with presbyopic correcting intraocular lenses is crucial. Understanding the defocus curve of pre-presbyopic and emerging presbyopic crystalline lens will provide eye care provides useful information to better educate patients on visual performance expectations after cataract surgery with a presbyopic correcting intraocular lens. Our objective will be to assess the subjective range of clear vision of a pre-presbyopic and emerging presbyopic patient population utilizing a defocus curve. A comparison of the pre-presbyopic and emerging presbyopic defocus curve to all FDA-approved presbyopic intraocular lenses will be discussed in the manuscript.

Detailed Description

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Conditions

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Presbyopia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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There is not an intervention

There is not an intervention

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Able and willing to provide written informed consent on the IRB approved Informed Consent Form
2. 37-48 years of age
3. Phakic

Exclusion Criteria

1. Previous cataract surgery
2. Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
3. Subjects that are unable to obtain 20/20 BCVA (i.e. amblyopia, etc.)
Minimum Eligible Age

37 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Vance Thompson Vision

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vance Thompson Vision

Sioux Falls, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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VT-2019-01

Identifier Type: -

Identifier Source: org_study_id

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