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

November 2, 2026 updated by: Clarity Eye Institute

Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments and Lock-In: A Prospective Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • Recruiting
        • Lumea
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Monocular Depth of Focus
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uncorrected Distance Visual Acuity
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

UDVA monocular and binocular
Baseline, prior to each UV adjustment, and prior to the first lock-in.
Uncorrected Near Visual Acuity
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

UNVA monocular and binocular
Baseline, prior to each UV adjustment, and prior to the first lock-in.
Best Corrected Distance Visual Acuity
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

BCDVA monocular
Baseline, prior to each UV adjustment, and prior to the first lock-in.
Manifest Refraction
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

Manifest refraction (sphere, cylinder, axis)
Baseline, prior to each UV adjustment, and prior to the first lock-in.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
iTrace-derived angle kappa
Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.

Angle Kappa from the iTrace will be taken at each step
Baseline, prior to each UV adjustment, and prior to the first lock-in.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clarity Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

September 28, 2026

First Submitted That Met QC Criteria

October 5, 2026

First Posted (Actual)

October 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEI-LAL-DOF-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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