Light Adjustable LensNCT07868003
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
An observational study of Light Adjustable Lens and Objective Depth of Focus, run by Clarity Eye Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Light Adjustable Lens, Objective Depth of Focus
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2026to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing bilateral cataract surgery with LAL implantation as part of standard clinical care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Lumea
Barrie, Ontario, L4M 7G1
Jacqueline Sun, 705-300-0741, Jsun@clarityeye.ca
About this study
Official title: 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.
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, prior to each UV adjustment, and prior to the first lock-in.
Secondary outcomes (4)
Uncorrected Distance Visual Acuity
UDVA monocular and binocular
Measured: Baseline, prior to each UV adjustment, and prior to the first lock-in.
Uncorrected Near Visual Acuity
UNVA monocular and binocular
Measured: Baseline, prior to each UV adjustment, and prior to the first lock-in.
Best Corrected Distance Visual Acuity
BCDVA monocular
Measured: Baseline, prior to each UV adjustment, and prior to the first lock-in.
Manifest Refraction
Manifest refraction (sphere, cylinder, axis)
Measured: Baseline, prior to each UV adjustment, and prior to the first lock-in.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Adjustable LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clarity Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868003
- Sponsor's protocol ID
- CEI-LAL-DOF-2026
- Status last verified
- Oct 2026
- First submitted
- 28 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments and Lock-In: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07868003
- Acronym / sponsor ID
- CEI-LAL-DOF-2026
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clarity Eye InstituteUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing bilateral cataract surgery with LAL implantation as part of standard clinical care.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Uncorrected Distance Visual Acuity
Time frame: 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.
Best Corrected Distance Visual Acuity
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Light Adjustable Lens
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
Astigmatism
Enrolling by invitationObservational study
Pseudoaccommodation of the Light Adjustable Lens: A Comparitive Study
Amplitude of Pseudoaccommodation
Enrolling by invitationObservational study
Clinical Outcomes of Patients with LAL+ in At Least One Eye
IOL, Cataract
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Light Adjustable Lens and Objective Depth of Focus, run by Clarity Eye Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Monocular Depth of Focus (time frame: Baseline, prior to each UV adjustment, and prior to the first lock-in.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.