Pseudoaccommodation of the Light Adjustable Lens: A Comparitive Study

NCT07176429 | Enrolling By Invitation FDA Device

• 1 other identifier: 2025-0503
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Amplitude of Pseudoaccommodation

Keywords

Pseudoaccommodation, light adjustable lens, monofocal lens

Outcome Measures

Primary Outcomes (1)

• Amplitude of pseudoaccommodation

  Range of near-vision as measured through best distance correction

  1 day

Study Arms (3)

Participants who have had the Light Adjustable Lens implanted with cataract surgery

Participants who have had the Light Adjustable Lens Plus implanted surgically

Device: Measurement of refractive error and amplitude of pseudoaccommodation

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

Interventions

Measurement of refractive error and amplitude of pseudoaccommodation DEVICE

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.

Also known as: Measurement of pupillary size, Measurement of spherical aberration of the eye

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

Sponsors & Collaborators

• Helm Vision Group: lead

Study Sites (1)

Helm Vision Group

Valencia, California, 91355, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Helm Vision Group

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 16, 2025
• Study Start: September 22, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: June 2026 through May 2031
• Access Criteria: The PI and study coordinator will have access to the collated data on the spreadsheet.

Locations

US (1)