ClinicalTrials.gg
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.

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Conditions studied

  • Cataract
  • Pseudophakia
03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's enrollment of 25 is below the median of 89 across 475 observational studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Vance Thompson Vision is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients able to sign
  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
  • Any pathology for which, in the investigator's judgement, could reduce the subjects BCVA
  • Unable to return for light treatments
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

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Study locations

1 site
  • Vance Thompson Vision
    Sioux Falls, South Dakota 57108, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2020 to primary completion in Jan 2021, 4 months.

Of 167 non-industry observational studies under Cataract, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 4 months is below that.

Counting every sponsor, half of 234 studies reached it within 16 months; a quarter within 9 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2020
First posted
Aug 31, 2020
StartActual
Sep 1, 2020
Primary completionActual
Jan 1, 2021
CompletionActual
Feb 1, 2021
Last update
May 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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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 ↗

Not currently enrolling

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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Discussion

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