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CompletedNCT04474782Updated Mar 30, 2021

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

An observational study in Presbyopia, sponsored by Vance Thompson Vision. Completed at 1 site in United States. Open to participants aged 37 Years to 48 Years. Per ClinicalTrials.gov, last updated 2021-03-30.

Sponsored by Vance Thompson Vision · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
45
Ages
37 Years to 48 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 51 observational studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
37 Years to 48 Years
Sexes eligible
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.

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

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.)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
45 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testThere is not an intervention

    There is not an intervention

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What researchers measure

Primary outcomes

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

    Time frame: Screening/enrollment visit

07

Study locations

1 site
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04474782
Lead sponsor
Vance Thompson Vision
Collaborators
Alcon Research
Responsible party
Sponsor
First posted
Jul 17, 2020
Start date
Oct 17, 2019
Primary completion
Aug 31, 2020
Completion
Aug 31, 2020
Last update
Mar 30, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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