Recruiting

Observational Study

Sponsor:

Clarity Eye Institute

Code:

NCT07868003

Conditions

Light Adjustable Lens

Objective Depth of Focus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07868003

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Objective Monocular Depth of Focus [ Time Frame: Baseline, prior to each UV adjustment, and prior to the first lock-in. ]

Central Contacts and Locations

Locations

Lumea

Recruiting

Barrie, Ontario, Canada, L4M 7G1

Contacts

Jacqueline Sun

705-300-0741Jsun@clarityeye.ca

More Information

Sponsor

Clarity Eye Institute

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Clarity Eye Institute on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.