NCT04474782

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

11 months

First QC Date

July 7, 2020

Last Update Submit

March 29, 2021

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Change in LogMar visual acuity during vision testing on ETDRS with loose lenses

    Screening/enrollment visit

Interventions

There is not an interventionDIAGNOSTIC_TEST

There is not an intervention

Eligibility Criteria

Age37 Years - 48 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Able and willing to provide written informed consent on the IRB approved Informed Consent Form
  • years of age
  • Phakic

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 17, 2020

Study Start

October 17, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)