Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

NCT04533191 — Completed, 25 participants, Vance Thompson Vision

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Registry	NCT04533191
Status	Completed
Study type	Observational
Enrollment	25 (Actual)
Sponsor	Vance Thompson Vision (Other)
Conditions	Cataract, Pseudophakia
Interventions	LAL IOL lens (Procedure)
Dates	start 2020-09-01, primary completion 2021-01-01, completion 2021-02-01, first posted 2020-08-31, last updated 2024-05-20
Locations	1 site in United States

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Subjects treated with LAL lens		Procedure: LAL IOL lens	Subjects that underwent standard of care cataract surgery and LAL IOL placement.

LAL IOL lens (Procedure): Standard of care Cataract surgery with IOL placement

+Outcome measures

Primary outcomes

Binocular uncorrected distance, intermediate, and near visual acuity [Through Month one post-op]
Binocular uncorrected depth of focus [Through Month one post-op]

Secondary outcomes

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 [Through Month one post-op]: Visual satisfaction will be obtained using a visual questionnaire
4th order total eye spherical aberration (Z12) [Through Month one post-op]

+Eligibility

Sex: All, ages: 18 Years to 110 Years

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

+Locations (1)

Facility	City	Country	Status
Vance Thompson Vision	Sioux Falls, South Dakota	United States