AphakiaNCT05202808

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Aphakia, Cataract
What is being tested?: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 14 sitesUnited States
Study dates: 3 Dec 2021to 16 Dec 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Willing and able to comply with the requirements for study specific procedures and visits.
Able to complete a written questionnaire in English.

Who cannot join

Pre-existing macular disease in either eye.
Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
History of uveitis in either eye.
Evidence of ectasia in either eye.
Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
Subjects taking systemic medication that may increase sensitivity to UV light.
Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
History of ocular herpes simplex virus in either eye.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Vance Thompson Vision
Alexandria, Minnesota, 56308
Cleveland Eye Clinic
Brecksville, Ohio, 44141
Reeve Woods Eye Center
Chico, California, 95926
Key-Whitman Eye Center
Dallas, Texas, 75235
Vold Vision
Fayetteville, Arkansas, 72704
Slade & Baker Vision
Houston, Texas, 77027
Texas Eye Research Center
Hurst, Texas, 76054
The Eye Institute of West Florida
Largo, Florida, 33770
Center for Sight
Las Vegas, Nevada, 89145
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, 29464
Vance Thompson Vision
Omaha, Nebraska, 68137
Focal Point Vision
San Antonio, Texas, 78229
Newsom Eye
Sebring, Florida, 33870
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, 57108

Other trials in United States

About this study

Official title: RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Conditions: Aphakia, Cataract
Being tested: Light Adjustable lens (LAL) and Light Delivery Device (LDD), Control IOL
Keywords: Light Adjustable Lens, LAL, Intraocular lens
Medical subject headings: Aphakia, Cataract

What participants receive

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

Light Adjustable lens (LAL) and Light Delivery Device (LDD)Device
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Control IOLDevice
Control treatment group will receive a Control IOL

Study groups in NCT05202808
Study group	Role	What they receive
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Experimental	Not described Receives: Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOL	Active comparator	Not described Receives: Device: Control IOL

What is being measured

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

Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Measured: Postop Month 6
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Measured: Postop Month 6

Secondary outcomes (2)

Rate of Endothelial Cell Density Loss
The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
Measured: Postop Month 6
Rate of Retinal Findings
Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.
Measured: Postop Month 6

Timeline

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

3 Dec 202116 Dec 2024

First posted24 Jan 2022
Study start3 Dec 2021
Primary completion11 Sep 2024
Study completion16 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AphakiaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized 2:1 to undergo experimental or control treatment.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05202808
Sponsor's protocol ID: CSP-029
Status last verified: Apr 2025
First submitted: 29 Dec 2021
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Schallhorn JM, Rajanala A. Clinical outcomes of patients bilaterally implanted with the light adjustable lens: results of a phase IV clinical registry. J Cataract Refract Surg. 2026 Oct 1;52(10):1015-1022. doi: 10.1097/j.jcrs.0000000000001994. Epub 2026 Jun 16.
PubMed 42302210
Holladay JT, Haller M. Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study. J Cataract Refract Surg. 2026 Jul 1;52(7):666-669. doi: 10.1097/j.jcrs.0000000000001906.
PubMed 41664266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Clinical Evaluation of a Novel Trifocal IOL
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Contralateral Claims Study of Clareon Vivity Pro
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Active, not recruiting
Feasibility Study of an Accommodating IOL Design
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Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
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Clinical Evaluation of the Adaptilens Accommodating IOL
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All Aphakia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
ClinicalTrials.gov ID: NCT05202808
Acronym / sponsor ID: CSP-029
Conditions: Aphakia, Cataract
Keywords: Light Adjustable Lens, LAL, Intraocular lens
Study type: Interventional
Recruitment status: Completed
Enrolment: 500 participants (actual)
Lead sponsor: RxSight, Inc.Industry (pharma, biotech, devices)
Study start: 3 Dec 2021 (actual)
Primary completion: 11 Sep 2024 (actual)
Study completion: 16 Dec 2024 (actual)
First posted: 24 Jan 2022 (actual)
Results: Posted 20 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Subjects will be randomized 2:1 to undergo experimental or control treatment.

Arm	Type	Receives
Light adjustable lens (LAL) and Light Delivery Device (LDD)	Experimental	Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOL	Active comparator	Device: Control IOL

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Willing and able to comply with the requirements for study specific procedures and visits.
Able to complete a written questionnaire in English.

Key exclusion criteria (8 listed)

Pre-existing macular disease in either eye.
Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
History of uveitis in either eye.
Evidence of ectasia in either eye.
Previous intraocular surgery in either eye. Eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.

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
Light Adjustable lens (LAL) and Light Delivery Device (LDD)Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Device	Light adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOLControl treatment group will receive a Control IOL	Device	Control IOL

Primary outcome

Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame: Postop Month 6

2 secondary outcomes

Rate of Endothelial Cell Density Loss
Time frame: Postop Month 6
Rate of Retinal Findings
Time frame: Postop Month 6

Results and safety

Results posted to the registry on 20 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	335	332
Control IOL	165	164

Primary outcome: Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control

Time frame: Postop Month 6. Mean (Standard Deviation). Unit: Diopters

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 332	Control IOL n = 164
Value	0.210 (0.213)	0.345 (0.265)

Primary outcome: Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

Time frame: Postop Month 6. Mean (Standard Deviation). Unit: Diopters

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 332	Control IOL n = 164
Value	0.262 (0.275)	0.820 (0.554)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	7 of 335 (2.1%)	71 of 335 (21.2%)	0 of 335
Control IOL	2 of 165 (1.2%)	26 of 165 (15.8%)	0 of 165

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42302210Schallhorn JM, Rajanala A. Clinical outcomes of patients bilaterally implanted with the light adjustable lens: results of a phase IV clinical registry. J Cataract Refract Surg. 2026 Oct 1;52(10):1015-1022. doi: 10.1097/j.jcrs.0000000000001994. Epub 2026 Jun 16.
Derived from this study: PubMed 41664266Holladay JT, Haller M. Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study. J Cataract Refract Surg. 2026 Jul 1;52(7):666-669. doi: 10.1097/j.jcrs.0000000000001906.
Individual participant dataSharing planned: No

Related trials for Aphakia

Recruiting
Clinical Evaluation of a Novel Trifocal IOL
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Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
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Active, not recruiting
Feasibility Study of an Accommodating IOL Design
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Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 14 sites 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?

The sponsor lists 4 inclusion and 8 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: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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?

Yes. Results are posted in the registry (first posted 20 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control (time frame: Postop Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05202808, which also lists 2 linked publications.

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 20 Apr 2025.