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Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04533191
Enrollment
25
Registered
2020-08-31
Start date
2020-09-01
Completion date
2021-02-01
Last updated
2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Pseudophakia

Brief 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.

Interventions

PROCEDURELAL IOL lens

Standard of care Cataract surgery with IOL placement

Sponsors

Vance Thompson Vision
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
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

Design outcomes

Primary

MeasureTime frame
Binocular uncorrected distance, intermediate, and near visual acuityThrough Month one post-op
Binocular uncorrected depth of focusThrough Month one post-op

Secondary

MeasureTime frameDescription
Monocular best corrected distance visual acuityThrough Month one post-op
Manifest refractionThrough Month one post-op
4th order total eye spherical aberration (Z12)Through Month one post-op
Visual SatisfactionThrough Month one post-opVisual satisfaction will be obtained using a visual questionnaire
Monocular uncorrected distance visual acuityThrough Month one post-op

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026