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Amplitude of PseudoaccommodationNCT07176429

Pseudoaccommodation of the Light Adjustable Lens: A Comparitive Study

An observational study of Amplitude of Pseudoaccommodation, run by Helm Vision Group at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Cataract surgery involves the removal of a cloudy natural lens, followed by the implantation of an artificial lens. The choice of lens implant helps determine what the vision will be like after surgery. "Monofocal" lens implants are not designed to give both distance and close-up vision at the same time. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amplitude of Pseudoaccommodation
What is being tested?
Measurement of refractive error and amplitude of pseudoaccommodation
Type of treatment
Medical device
How many people
180 participants
Where
1 siteUnited States
Study dates
22 Sep 2025to Apr 2026
How long will I take part?
1 Day
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Those who have had cataract surgery with the Light Adjustable Lens, the Light Adjustable Lens Plus, or the Akreos AO60 lens implant.

Inclusion Criteria: Those who have had cataract surgery with implantation of either the Light Adjustable Lens or the Light Adjustable Lens Plus, or the Akreos AO60 lens implants. Must have not had previous keratorefractive surgery and no ocular pathology that precludes being correctable to 20/20 vision.

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Exclusion Criteria: Those under 18 years of age, those unable to give informed consent, prisoners, or those who are pregnant.

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Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Helm Vision Group

    Valencia, California, 91355

Other trials in United States

About this study

Official title: Pseudoaccommodation of the Light Adjustable Lens: A Comparative Study

Cataract surgery involves the removal of a cloudy natural lens, followed by the implantation of an artificial lens. The choice of lens implant helps determine what the vision will be like after surgery. "Monofocal" lens implants are not designed to give both distance and close-up vision at the same time. We wish to study the amount of reading ability that a lens implant corrected for distance vision will provide. Eligible study participants include those who have had cataract surgery with implantation of either the Light Adjustable Lens® (LAL), the Light Adjustable Lens Plus® (LAL+) or the Bausch \& Lomb Akreos® AO60 lens implant. We anticipate enrolling up to 100 subjects in this study.

These lens implants are designed to achieve excellent distance vision, inasmuch as the lens implant target is achieved. The lens implant target of excellent, unaided distance vision is more likely to be achieved when the chosen power of the lens implant matches the eye's curvature and length. Before cataract surgery, the eye is measured by a machine, and the information is used to calculate which lens power is predicted to best match the eye. In the case of the LAL, a light delivery device is used after surgery to fine-tune the power of the lens implant and achieve sharper unaided vision.

Read more

Although both of these lens implants are technically "monofocal" lenses and work well for distance vision, they differ in ways that affect near vision. "Pseudoaccommodation" is the term that refers to the ability of an eye with a lens implant to see up close without glasses. The optical qualities of the Light Adjustable Lens generally allow eyes implanted with this lens to see objects at an intermediate or close-up range without glasses. The amount of pseudoaccommodation or close-up ability in these eyes differs from person to person.

The purpose of this study is to determine the average amount of reading ability in eyes implanted with the Light Adjustable Lens® and compare it to the amount measured with the Bausch \& Lomb AO60 lens.

Read the detailed description

The purpose of this study is to measure the capability of three different monofocal (non-multifocal) lens implants to also provide near vision when corrected for distance vision. We will be comparing two versions of the Light Adjustable Lens® (RxSight, Irvine, CA) and also the Akreos® AO60 lens (Bausch \& Lomb, Bridgewater, NJ). All three of these lens FDA-approved lens implants were categorized as being "monofocal", meaning that all light rays entering the eye are focused at one particular point. This means that when eyes that have these types of lens implants are corrected to see well at distance, that the near vision should be poor (when not wearing bifocals or other glasses to specifically aid near vision. The Light Adjustable Lenses are touted as having an unusually high ability to deliver reading vision in addition to distance vision, despite being a monofocal lens. We aim to determine what the range of near vision is (defined as "pseudoaccommodation") for the Light Adjustable Lens, the Light Adjustable Lens Plus, and the Akreos® AO60 lens. We have not found this information available on a PubMed search. This information would be very useful clinically for counselling patients prior to cataract surgery. It would also help determine if there is a correlation between those who end up having a high degree of pseudoaccommodation and other factors such as pupil size and total amount of spherical aberration of the eye (which is thought to influence near vision).

Cataract surgery consists of the removal of the natural crystalline lens of the eye when the lens becomes cloudy. To restore the focusing power of the eye, an artificial lens is typically implanted immediately after cataract removal, during the same operation. The lens implants are made in a range of powers that allow selection of a power that corrects the refractive error of the eye and reduces or eliminates the need for glasses or contact lenses. The Light Adjustable Lens® (LAL) by RxSight is the world's only lens implant that allows the lens implant power to be adjusted or fine-tuned after it's been implanted into the eye.

"Accommodation" is the process by which the natural lens is changed in shape and position to allow a person to see both far and near without glasses. This ability is gradually lost, usually beginning in the mid-40s, when a person starts to develop a need for reading glasses. This happens as the natural crystalline lens begins to lose its elasticity. The Helmholtz theory is the most widely held theory for how accommodation works. It holds that the effort to see near objects causes contraction of the ciliary body in the eye. The crystalline lens is attached to the ciliary body via zonules or fibers. Thus, when the ciliary body contracts, the tension on the zonules loosens, allowing the lens to thicken and shift forward in position. These changes increase the focusing power of the eye. Therefore, when the lens loses its elasticity, it becomes less able to thicken and increase its focusing power. When cataract surgery is performed and a lens implant is placed, because the lens implant is rigid, true accommodation is lost. However, some ability to see both distant objects and near objects is maintained to some degree. This ability to see both far and near in an eye that has had a lens implant placed is called "pseudoaccommodation". Pseudoaccommodation can result from a combination of factors, including forward movement of the lens implant with contraction of the ciliary body, pupil size, and residual spherical aberration of the eye. "Spherical aberration" is a type of optical distortion that occurs because with a curved surface, light rays are focused either more strongly (positive spherical aberration) or less strongly (negative spherical aberration) as the rays pass through the surface further away from its center. This means that not all light rays are focused at one point. Rather, a range of reduced sharpness is produced, resulting in a range of less clear vision, instead of a single focal point of clarity.

In addition to its ability to be adjusted to fine-tune distance vision, the LAL is associated with increased near vision in subjects who also have good distance vision. In other words, this lens implant seems to provide a higher-than-normal degree of pseudoaccommodation compared to other monofocal (non-multifocal) lens implants. Although encountered in clinical practice, the reasons for this high degree of pseudoaccommodation are complicated. It is believed, in part, to be related to the shape of the lens implant, which produces negative spherical aberration. Clinically, the reading ability of recipients of the lens varies from person to person. This may be partly related to the differing amounts of residual spherical aberration that are left in the eye after the LAL has been adjusted with the light delivery device to fine-tune the visual acuity.

Being tested
Measurement of refractive error and amplitude of pseudoaccommodation
Keywords
Pseudoaccommodation, light adjustable lens, monofocal lens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measurement of refractive error and amplitude of pseudoaccommodationDevice

    Also called Measurement of pupillary size, Measurement of spherical aberration of the eye

    We will be using an assessor, masked as to which participant received what particular lens implant to determine the range of pseudoaccommodation in each eye. This will be done for each eligible eye and the 3 cohorts will be studied and compared.

Study groups in NCT07176429
Study groupRoleWhat they receive
Participants who have had the Light Adjustable Lens implanted with cataract surgeryParticipants who have had the Light Adjustable Lens Plus implanted surgically
Receives: Device: Measurement of refractive error and amplitude of pseudoaccommodation
Participants who have had the Akreos AO60 lens implanted with cataract surgeryNot described
Receives: Device: Measurement of refractive error and amplitude of pseudoaccommodation
Participants who have had the Light Adjustable Lens Plus implantedNot described
Receives: Device: Measurement of refractive error and amplitude of pseudoaccommodation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amplitude of pseudoaccommodation

    Range of near-vision as measured through best distance correction

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start22 Sep 2025 (estimated)
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

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
180 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07176429
Sponsor's protocol ID
2025-0503
Status last verified
Sep 2025
First submitted
10 Sep 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We can share our raw data from our spreadsheet.

Questions about this trial

What is this clinical trial studying?

An observational study of Amplitude of Pseudoaccommodation, run by Helm Vision Group at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. 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 United States. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude of pseudoaccommodation (time frame: 1 day). 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 16 Sep 2025.

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