Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

The objective of this investigator initiated study (IIT-001) is to obtain data on clinical methods which can be used during the examination of patients desiring binocular custom vision with the Light Adjustable Lens (LAL). An analysis of the collected data will be performed to determine whether these clinical assessments can be used by doctors to enhance their patient's clinical outcome.

Study Overview

• Status: Unknown
• Conditions: Cataract; Pseudophakia
• Intervention / Treatment: Procedure: Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A population of 25 patients who plan to undergo bilateral cataract surgery with implantation of commercially available Light Adjustable Lens (LAL) and receive binocular custom vision.

Description

Inclusion Criteria:

1. Patients able to sign informed consent
2. Patients who plan to undergo bilateral implantation with the commercial LAL and receive binocular custom vision are eligible for study participation.

Exclusion Criteria:

• Inability to sign informed consent
• Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
• Unable to return for light treatments

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular uncorrected distance, intermediate, and near visual acuity	Through Month one post-op
Binocular uncorrected depth of focus	Through Month one post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manifest refraction		Through Month one post-op
Monocular uncorrected distance visual acuity		Through Month one post-op
Monocular best corrected distance visual acuity		Through Month one post-op
Visual Satisfaction	Visual satisfaction will be obtained using a visual questionnaire	Through Month one post-op
4th order total eye spherical aberration (Z12)		Through Month one post-op

Collaborators and Investigators

• Sponsor: Vance Thompson Vision

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Pseudophakia
• Other Study ID Numbers: IIT-001

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: Yes
• product manufactured in and exported from the U.S.: No