ClinicalTrials.gg
RecruitingNCT07868003Updated Nov 4, 2026

Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments

An observational study in Light Adjustable Lens and Objective Depth of Focus, sponsored by Clarity Eye Institute. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Clarity Eye Institute · Observational

Updated Nov 4, 2026Now RecruitingSite recruiting status changed+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

This observational pilot study will examine how a person's vision changes during the routine adjustment and finalization of a Light Adjustable Lens (LAL) after surgery. The study will focus on objective depth of focus, measured using iTrace wavefront analyzer, which describes how clearly a person can see at different distances. This is a non-invasive eye test that will be used alongside the standard lens adjustment process. This study will help researchers understand why some patients achieve unexpectedly good near or intermediate vision after LAL adjustments despite being targeted for emmetropia.

02

Conditions studied

  • Light Adjustable Lens
  • Objective Depth of Focus

Keywords

  • Light Adjustable Lens
  • LAL
  • Objective Depth of Focus
  • Cataract Surgery
  • Alpha Kappa
  • Intraocular Lens
  • iTrace
  • Visual Quality
03

In context

Lead sponsor

Clarity Eye Institute is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults undergoing bilateral cataract surgery with LAL implantation as part of standard clinical care.

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

  • Adults ≥18 years of age.
  • Scheduled to undergo bilateral cataract extraction with LAL implantation as standard-of-care.
  • Able to provide written .
  • Able to comply with study visits and required assessments throughout the LAL adjustment and lock-in sequence.

Exclusion criteria

Exclusion Criteria:

  • Presence of ocular comorbidities in either eye that may affect visual outcomes or wavefront measurements, including but not limited to glaucoma, age-related macular degeneration, diabetic retinopathy, corneal disease, amblyopia, or prior refractive surgery.
  • Intraoperative complications affecting IOL positioning, centration, or stability.
  • Inability to obtain reliable iTrace measurements due to inadequate fixation or poor measurement quality.
  • Participation in another interventional ophthalmic clinical study.
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
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Objective Monocular Depth of Focus

    Change in objective monocular depth of focus throughout the LAL UV adjustment and lock-in sequence, measured using the iTrace wavefront aberrometry system. Objective monocular depth of focus will be quantified using the VSOTF-based DOF profile and reported as the DOF range (D) at each timepoint.

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

Secondary outcomes

  1. Uncorrected Distance Visual Acuity

    UDVA monocular and binocular

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

  2. Uncorrected Near Visual Acuity

    UNVA monocular and binocular

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

  3. Best Corrected Distance Visual Acuity

    BCDVA monocular

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

  4. Manifest Refraction

    Manifest refraction (sphere, cylinder, axis)

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

Other outcomes

  1. iTrace-derived angle kappa

    Angle Kappa from the iTrace will be taken at each step

    Time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

07

Study locations

1 of 1 sites recruiting
  • Lumea
    Barrie, Ontario L4M 7G1, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2026 (actual). Primary completion is estimated for Jun 2027, 7 months after the start.

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

Registered
Sep 28, 2026
First posted
Oct 9, 2026
StartActual
Nov 2, 2026
Primary completionEst.
Jun 30, 2027
CompletionEst.
Aug 31, 2027
Last update
Nov 4, 2026
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.
Status
Not yet recruiting→Recruiting
changed Nov 4, 2026
Sites
Lumea is now Recruiting
Nov 4, 2026
Start date
Nov 1, 2026→Nov 2, 2026 (actual)
Nov 4, 2026
Registered
First appeared on the registry
Oct 9, 2026
Show all 2 updates
  1. Nov 4, 2026
    Not yet recruiting→Recruiting
    Lumea is now Recruiting
    Start date Nov 1, 2026→Nov 2, 2026 (now actual)
    + 1 other change: verification date
  2. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868003
Lead sponsor
Clarity Eye Institute
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Nov 2, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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