Skip to main content
OpenTrials
Completed

NCT Number: NCT04533191

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases Pathological Conditions, Signs and Symptoms Pseudophakia Signs and Symptoms

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vance Thompson Vision

Sioux Falls, South Dakota, 57108, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients able to sign informed consent
  • 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

Treatment and study plan

LAL IOL lens

Procedure

Standard of care Cataract surgery with IOL placement

Primary outcomes

  1. Binocular uncorrected distance, intermediate, and near visual acuity

    Time frame: Through Month one post-op

  2. Binocular uncorrected depth of focus

    Time frame: Through Month one post-op

Secondary outcomes

  1. Manifest refraction

    Time frame: Through Month one post-op

  2. Monocular uncorrected distance visual acuity

    Time frame: Through Month one post-op

  3. Monocular best corrected distance visual acuity

    Time frame: Through Month one post-op

  4. Visual Satisfaction

    Time frame: Through Month one post-op

    Visual satisfaction will be obtained using a visual questionnaire

  5. 4th order total eye spherical aberration (Z12)

    Time frame: Through Month one post-op

Sponsors and collaborators

Lead sponsor

Vance Thompson Vision

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2020
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.