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Pseudoaccommodation of the Light Adjustable Lens: A Comparitive Study

NCT07176429 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2025-09-16

No results posted yet for this study

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

Interventions

DEVICE

Measurement of refractive error and amplitude of pseudoaccommodation

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.

Sponsors & Collaborators

  • Helm Vision Group

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176429 on ClinicalTrials.gov