AphakiaNCT04529616

Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 1 site in Mexico.

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 objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. Read more about this study

Who is it for?: Ages 30 years and older
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: 79 participants
Where: 1 siteMexico
Study dates: 22 May 2020to 1 Oct 2022
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 30 years and older
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 unilateral or bilateral implantation of the RxLAL.
Age 30 or older on the day the cataract surgery is performed.
Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
Willing and able to comply with the requirements for study specific procedures and visits.

Who cannot join

Study eye with zonular laxity or dehiscence.
Study eye with diabetes with any evidence of retinopathy.
Study eye with history of uveitis.
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.
Study eye with history of ocular herpes simplex virus.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

CODET Vision Institute
Tijuana

Other trials in Mexico

About this study

Conditions: Aphakia, Cataract
Being tested: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Keywords: Light Adjustable Lens, Intraocular lens, LAL
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
Eligible eyes will receive Light adjustable lens with Light delivery Device treatments

Study groups in NCT04529616
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)

What is being measured

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

Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
Measured: 3 months post op
Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better
Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment
Measured: 12 months post op

Timeline

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

22 May 20201 Oct 2022

First posted27 Aug 2020
Study start22 May 2020
Primary completion1 Oct 2022
Study completion1 Oct 2022

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04529616
Sponsor's protocol ID: CSP-036
Status last verified: Feb 2025
First submitted: 24 Aug 2020
Last updated: 10 Feb 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

Recruiting
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 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes
ClinicalTrials.gov ID: NCT04529616
Acronym / sponsor ID: CSP-036
Conditions: Aphakia, Cataract
Keywords: Light Adjustable Lens, Intraocular lens, LAL
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: RxSight, Inc.Industry (pharma, biotech, devices)
Study start: 22 May 2020 (actual)
Primary completion: 1 Oct 2022 (actual)
Study completion: 1 Oct 2022 (actual)
First posted: 27 Aug 2020 (actual)
Results: Posted 10 Feb 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

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

Who may qualify

Ages: 30 years and older
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 unilateral or bilateral implantation of the RxLAL.
Age 30 or older on the day the cataract surgery is performed.
Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
Willing and able to comply with the requirements for study specific procedures and visits.

Key exclusion criteria (6 listed)

Study eye with zonular laxity or dehiscence.
Study eye with diabetes with any evidence of retinopathy.
Study eye with history of uveitis.
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.

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)Eligible eyes will receive Light adjustable lens with Light delivery Device treatments	Device	Light adjustable lens (LAL) and Light Delivery Device (LDD)

Primary outcome

Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Time frame: 3 months post op
Values were measured via Early Treatment Diabetic Retinopathy Study (ETDRS) testing.
Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better
Time frame: 12 months post op
Visual performance parameters will be collected and summarized for eyes that received a presbyopia adjustment

Results and safety

Results posted to the registry on 10 Feb 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)	79	79

Primary outcome: Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

Time frame: 3 months post op. Count of units. Unit: Eyes

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 32
Value	21

Primary outcome: Proportion of Eyes Simultaneously With (1) Monocular UCDVA of 20/25 or Better and (2) Monocular Uncorrected Intermediate Visual Acuity (UCIVA) of 20/32 or Better and (3) Monocular Uncorrected Near Visual Acuity (UCNVA) of 20/40 or Better

Time frame: 12 months post op. Count of units. Unit: Eyes

Measure	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) n = 79
Value	91

Adverse events

Time frame: 12 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)	2 of 79 (2.5%)	9 of 79 (11.4%)	1 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Aphakia

Recruiting
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

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?

A study testing Light Adjustable lens (LAL) and Light Delivery Device (LDD) in people with Aphakia and Cataract, run by RxSight, Inc. at 1 site in Mexico.

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 6 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 10 Feb 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 Mexico. 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 10 Feb 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?

Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better (time frame: 3 months post op). 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 NCT04529616.

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 10 Feb 2025.