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CompletedNCT04533191Updated May 20, 2024

Binocular Custom Vision Utilizing The Light Adjustable Lens (LAL)

An observational study in Cataract and Pseudophakia, sponsored by Vance Thompson Vision. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by Vance Thompson Vision · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cataract
  • Pseudophakia
03

Who can participate

Ages eligible
18 Years to 110 Years
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Subjects treated with LAL lens

    Subjects that underwent standard of care cataract surgery and LAL IOL placement.

    Procedure: LAL IOL lens

Interventions

  • ProcedureLAL IOL lens

    Standard of care Cataract surgery with IOL placement

05

What researchers measure

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

    Visual satisfaction will be obtained using a visual questionnaire

    Time frame: Through Month one post-op

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

    Time frame: Through Month one post-op

06

Study locations

1 site
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04533191
Lead sponsor
Vance Thompson Vision
Responsible party
Sponsor
First posted
Aug 31, 2020
Start date
Sep 1, 2020
Primary completion
Jan 1, 2021
Completion
Feb 1, 2021
Last update
May 20, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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