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.
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.
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.
- Conditions
- Amplitude of Pseudoaccommodation
- 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 group | Role | What they receive |
|---|---|---|
| Participants who have had the Light Adjustable Lens implanted with cataract surgery | Participants 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 surgery | Not described Receives: Device: Measurement of refractive error and amplitude of pseudoaccommodation | |
| Participants who have had the Light Adjustable Lens Plus implanted | Not 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.
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.
- First posted16 Sep 2025
- Study start22 Sep 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amplitude of PseudoaccommodationStudies 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
- 180 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Helm Vision Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig J. Helm, Helm Vision Group
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pseudoaccommodation of the Light Adjustable Lens: A Comparative Study
- ClinicalTrials.gov ID
- NCT07176429
- Acronym / sponsor ID
- 2025-0503
- Conditions
- Amplitude of Pseudoaccommodation
- Keywords
- Pseudoaccommodation, light adjustable lens, monofocal lens
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Helm Vision GroupUniversity, hospital or other
- Study start
- 22 Sep 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants who have had the Light Adjustable Lens implanted with cataract surgery | – | Device: Measurement of refractive error and amplitude of pseudoaccommodationParticipants who have had the Light Adjustable Lens Plus implanted surgically |
| Participants who have had the Akreos AO60 lens implanted with cataract surgery | – | Device: Measurement of refractive error and amplitude of pseudoaccommodation |
| Participants who have had the Light Adjustable Lens Plus implanted | – | Device: Measurement of refractive error and amplitude of pseudoaccommodation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of refractive error and amplitude of pseudoaccommodationAlso: Measurement of pupillary size, Measurement of spherical aberration of the eyeWe 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. | Device | Participants who have had the Akreos AO60 lens implanted with cataract surgery, Participants who have had the Light Adjustable Lens Plus implanted, Participants who have had the Light Adjustable Lens implanted with cataract surgery |
Primary outcome
Amplitude of pseudoaccommodation
Time frame: 1 day
Range of near-vision as measured through best distance correction
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 16 Sep 2025.
- Individual participant dataSharing planned: Yes. We can share our raw data from our spreadsheet.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.