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

NCT07868003 | Not Yet Recruiting

• 1 other identifier: CEI-LAL-DOF-2026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

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

Secondary Outcomes (4)

• Uncorrected Distance Visual Acuity

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

• Uncorrected Near Visual Acuity

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

• Best Corrected Distance Visual Acuity

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

• Manifest Refraction

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

Other Outcomes (1)

• iTrace-derived angle kappa

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clarity Eye Institute: lead

Study Sites (1)

Lumea

Barrie, Ontario, L4M 7G1, Canada

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)