AphakiaNCT04177771

A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population, SofPort LI61AO IOL and Tecnis ZCB00 or ZTC150 IOL in people with Aphakia and Cataract, run by RxSight, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Aphakia, Cataract, Presbyopia
What is being tested?: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population, SofPort LI61AO IOL and Tecnis ZCB00 or ZTC150 IOL
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2019to 20 Dec 2021
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 bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes.
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.
Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
Diabetes with any evidence of retinopathy in either eye.
Evidence of glaucomatous optic neuropathy in either eye.
History of uveitis in either eye.
Keratoconus or suspected of having keratoconus in either eye.

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Has undergone previous corneal or intraocular surgery in either eye, except 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 such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
History of ocular herpes simplex virus in either eye.
Subject who has participated within another ophthalmic clinical trial within the last 3 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Vold Vision
Fayetteville, Arkansas, 72704

Other trials in United States

About this study

Official title: A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

Conditions: Aphakia, Cataract, Presbyopia
Being tested: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population, SofPort LI61AO IOL, Tecnis ZCB00 or ZTC150 IOL
Keywords: Light Adjustable Lens, Intraocular lens, LAL
Medical subject headings: Aphakia, Cataract, Presbyopia

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) - Pre-COVID PopulationDevice
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
SofPort LI61AO IOLDevice
Control treatment group will receive SofPort LI61AO IOL
Tecnis ZCB00 or ZTC150 IOLDevice
Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

Study groups in NCT04177771
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) - Pre-COVID Population
SofPort LI61AO IOL	Active comparator	Not described Receives: Device: SofPort LI61AO IOL; Device: Tecnis ZCB00 or ZTC150 IOL

What is being measured

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

Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group
Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.
Measured: Postop Month 6
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group
Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups
Measured: Postop Month 6
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6
Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR
Measured: 6 months
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group
Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups
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.

15 Nov 201920 Dec 2021

First posted26 Nov 2019
Study start15 Nov 2019
Primary completion20 Dec 2021
Study completion20 Dec 2021

Why it stopped: Technology changes.

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.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized 1:1 to undergo experimental or control treatment.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04177771
Sponsor's protocol ID: CSP-033
Status last verified: Dec 2024
First submitted: 22 Nov 2019
Last updated: 7 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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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Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
Not yet recruiting
Clinical Evaluation of the Adaptilens Accommodating IOL
Aphakia Cataract

All Aphakia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
ClinicalTrials.gov ID: NCT04177771
Acronym / sponsor ID: CSP-033
Conditions: Aphakia, Cataract, Presbyopia
Keywords: Light Adjustable Lens, Intraocular lens, LAL
Study type: Interventional
Recruitment status: TerminatedReason stopped: Technology changes.
Enrolment: 34 participants (actual)
Lead sponsor: RxSight, Inc.Industry (pharma, biotech, devices)
Study start: 15 Nov 2019 (actual)
Primary completion: 20 Dec 2021 (actual)
Study completion: 20 Dec 2021 (actual)
First posted: 26 Nov 2019 (actual)
Results: Posted 7 Jan 2025

Clinical summary

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

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 1:1 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) - Pre-COVID Population
SofPort LI61AO IOL	Active comparator	Device: SofPort LI61AO IOL, Device: Tecnis ZCB00 or ZTC150 IOL

Who may qualify

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

Key inclusion criteria (6 listed)

Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes.
Willing and able to comply with the requirements for study specific procedures and visits.

Key exclusion criteria (11 listed)

Pre-existing macular disease in either eye.
Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
Diabetes with any evidence of retinopathy in either eye.
Evidence of glaucomatous optic neuropathy in either eye.
History of uveitis in either eye.

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) - Pre-COVID PopulationExperimental treatment group will receive Light adjustable lens with Light delivery Device treatments	Device	Light adjustable lens (LAL) and Light Delivery Device (LDD)
SofPort LI61AO IOLControl treatment group will receive SofPort LI61AO IOL	Device	SofPort LI61AO IOL
Tecnis ZCB00 or ZTC150 IOLControl treatment group will receive Tecnis ZCB00 or ZTC150 IOL	Device	SofPort LI61AO IOL

Primary outcome

Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group
Time frame: Postop Month 6
Comparison of monocular distance visual acuity (VA) in logMAR, measured with different spherical lens powers over the eye. The lens diopter value corresponding to the intercepted point of the 0.20 logMAR visual acuity was determined by interpolation for each group mean. The DOF at Postop Month 6 was the absolute difference between the negative lens diopter value corresponding to the 0.20 logMAR visual acuity and 0 diopter for each group.
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group
Time frame: Postop Month 6
Comparison of monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm between LAL treatment and control groups
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6
Time frame: 6 months
Percent of LAL treatment group with monocular Distance-Corrected Intermediate Visual Acuity measured at 67 cm better than or equal to 0.20 logMAR
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group
Time frame: Postop Month 6
Comparison of monocular Best-Corrected Distance Visual Acuity between LAL treatment and control groups

Results and safety

Results posted to the registry on 7 Jan 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)	10	10
Tecnis ZCB00 or ZTC150 IOL	7	7
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	0	0
SofPort LI61AO IOL	0	0

Primary outcome: Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group

Time frame: Postop Month 6. Number. Unit: Diopters

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n = 10	Tecnis ZCB00 or ZTC150 IOL n = 7	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n = 7	SofPort LI61AO IOL n = 10
Value	2.30	0.97	1.58	0.85

Primary outcome: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group

Time frame: Postop Month 6. Mean (95% Confidence Interval). Unit: LogMAR

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n = 10	Tecnis ZCB00 or ZTC150 IOL n = 7	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n = 7	SofPort LI61AO IOL n = 10
Value	0.09 (-0.02 to 0.19)	0.29 (0.13 to 0.44)	0.13 (0.01 to 0.26)	0.33 (0.21 to 0.46)

Population analysed: Since the sample sizes of each group did not meet the minimum requirements (8 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.

Primary outcome: Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6

Time frame: 6 months. Number (95% Confidence Interval). Unit: percentage of Primary Eyes

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n = 10	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n = 7
Value	80 (44.4 to 97.5)	71.4 (29.0 to 96.3)

Population analysed: Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled (Light adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID population and TECNIS ZCB00 or ZTC150 IOL) may have been delayed outside protocol specified windows or missed completely. Since the sample sizes of each group did not meet the minimum requirements (28 eyes per lens group) for statistical power per study protocol, 95% confidence intervals were calculated.

Primary outcome: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group

Time frame: Postop Month 6. Mean (95% Confidence Interval). Unit: LogMAR

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population n = 10	Tecnis ZCB00 or ZTC150 IOL n = 7	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population n = 7	SofPort LI61AO IOL n = 10
Value	0.00 (-0.08 to 0.09)	-0.11 (-0.16 to -0.05)	0.02 (-0.09 to 0.12)	-0.06 (-0.13 to 0.01)

Population analysed: Since the sample sizes of each group did not meet the minimum requirements (42 eyes per lens group) for statistical power per study protocol, a mean difference comparison test was not performed. 95% confidence intervals were calculated and compared between groups.

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) - Pre-COVID Population	1 of 10 (10%)	9 of 10 (90%)	0 of 10
Tecnis ZCB00 or ZTC150 IOL	1 of 7 (14.3%)	2 of 7 (28.6%)	0 of 7
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	1 of 7 (14.3%)	4 of 7 (57.1%)	0 of 7
SofPort LI61AO IOL	1 of 10 (10%)	1 of 10 (10%)	0 of 10

Limitations and caveats (from the sponsor): Due to the COVID-19 pandemic, study visits for the first 17 subjects enrolled may have been delayed outside protocol specified windows or missed completely. Per the protocol, these subjects will be excluded from the Full Analysis Set populations. Based on the sample size calculations, at least 42 subjects per lens group with available monocular photopic BCDVA and DCIVA for the primary eyes at Postop Month 6 were needed; however, the sample size was too small to analyze these endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Aphakia

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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.

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 7 Jan 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?

Yes. Results are posted in the registry (first posted 7 Jan 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?

Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group (time frame: Postop Month 6). The study lists 4 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 NCT04177771.

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 7 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.