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

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474782
• Other study ID #: VT-2019-01
• Status: Completed
• Start date: October 17, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2021
• Source: Vance Thompson Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Gender: All
• Age group: 37 Years to 48 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Presbyopia

Intervention

Diagnostic Test:
• There is not an intervention
There is not an intervention

Locations

Country	Name	City	State
United States	Vance Thompson Vision	Sioux Falls	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Vance Thompson Vision	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LogMar visual acuity during vision testing on ETDRS with loose lenses		Screening/enrollment visit