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

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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Diagnostic test: There is not an intervention

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • Vance Thompson Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 37 years to 48 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A population of 30-60 subjects will be selected for testing. Subjects can be male or female, ages 37-48.

Description

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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LogMar visual acuity during vision testing on ETDRS with loose lenses	Screening/enrollment visit

Collaborators and Investigators

• Sponsor: Vance Thompson Vision
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: VT-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No