TerminatedNCT04177771Updated Jan 7, 2025Results posted

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

An interventional study of Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population and SofPort LI61AO IOL in Aphakia, Cataract and Presbyopia, sponsored by RxSight, Inc.. Terminated at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by RxSight, Inc. · Interventional and Treatment

Why this study was terminated

Technology changes.

Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 40 Years to 80 Years
Sex: All

Study 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 who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).

Conditions studied

Aphakia
Cataract
Presbyopia

Browse trials for

Keywords

Light Adjustable Lens
Intraocular lens
LAL

In context

Aphakia

69 studies on the registry are indexed under Aphakia; 6 are open to participants now.

This study's enrollment of 34 is below the median of 103 across 52 interventional studies indexed under Aphakia.

Browse Aphakia studies →

Lead sponsor

RxSight, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Must sign a written 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.

Exclusion criteria

Exclusion Criteria:

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.
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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Study design

Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 34 participants (actual)

Study arms

Experimental
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population
Active comparator
SofPort LI61AO IOL
Device: SofPort LI61AO IOL · Device: Tecnis ZCB00 or ZTC150 IOL

Interventions

DeviceLight Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
DeviceSofPort LI61AO IOL
Control treatment group will receive SofPort LI61AO IOL
DeviceTecnis ZCB00 or ZTC150 IOL
Control treatment group will receive Tecnis ZCB00 or ZTC150 IOL

What researchers measure

Primary outcomes

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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Postop Month 6

Results

Posted Jan 7, 2025

Limitations and caveats

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.

Participant flow

Pre-COVID Population

Participant flow — Pre-COVID Population
Milestone	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)	Tecnis ZCB00 or ZTC150 IOL
Started	10	7
Completed	10	7
Not completed	0	0

Modified Safety Population

Participant flow — Modified Safety Population
Milestone	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Started	7	10
Completed	7	10
Not completed	0	0

Outcome measures

PrimaryMonocular 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.

Time frame:: Postop Month 6
Reported as:: Number · Diopters

Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group
Diopters	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group	2.30	0.97	1.58	0.85

PrimaryMonocular 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

Time frame:: Postop Month 6
Reported as:: Mean · LogMAR

Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group
LogMAR	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group	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)

PrimaryOutcome 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

Time frame:: 6 months
Reported as:: Number · percentage of Primary Eyes

Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6
percentage of Primary Eyes	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population
Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6	80 (44.4 to 97.5)	71.4 (29.0 to 96.3)

PrimaryMonocular 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

Time frame:: Postop Month 6
Reported as:: Mean · LogMAR

Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group
LogMAR	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group	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)

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	0/10 (0%)	1/10 (10%)	9/10 (90%)
Tecnis ZCB00 or ZTC150 IOL	0/7 (0%)	1/7 (14.3%)	2/7 (28.6%)
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	0/7 (0%)	1/7 (14.3%)	4/7 (57.1%)
SofPort LI61AO IOL	0/10 (0%)	1/10 (10%)	1/10 (10%)

Most frequent serious events

Most frequent serious events
Event	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Gall bladder removalHepatobiliary disorders	0/10	0/7	1/7	0/10
Laparoscopic cholecystectomy for gall stonesHepatobiliary disorders	0/10	1/7	0/7	0/10
Acute coronary syndromeCardiac disorders	0/10	0/7	0/7	1/10
Internal and external hemorrhoids requiring hospitalizationSkin and subcutaneous tissue disorders	1/10	0/7	0/7	0/10

Most frequent other events

Most frequent other events
Event	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL
Primary and Fellow Eye, BCDVA letter drop 10 letters or worse compared to week 3Eye disorders	5/10	1/7	3/7	0/10
Primary and Fellow Eye, Posterior capsular opacity requiring YAGEye disorders	5/10	1/7	3/7	1/10
Primary and Fellow Eye, Subjective symptom of much less crisp visionEye disorders	0/10	1/7	0/7	0/10
Primary and Fellow Eye, Non-clinically significant cystoid macular edemaEye disorders	1/10	0/7	0/7	0/10
Primary and Fellow Eye, Punctate Epithelial Erosion causing watery and uncomfortable eyeEye disorders	1/10	0/7	0/7	0/10
Primary and Fellow Eye, Subjective symptom of blurry vision, red in lights and starburstsEye disorders	1/10	0/7	0/7	0/10
Primary and Fellow Eye, Glare or halos or double/multiple imagesEye disorders	1/10	0/7	0/7	0/10
Primary and Fellow Eye, DrusenEye disorders	1/10	0/7	0/7	0/10
Primary and Fellow Eye, Cellulitis, hordeolumEye disorders	1/10	0/7	0/7	0/10

Baseline characteristics

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. Per the protocol, these subjects will be excluded from the Full Analysis Set populations.

Age, Continuous
Age, Continuous(years)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL	Total
Mean	64.9 ± 8.7	69.2 ± 5.5	65.4 ± 8.5	66.6 ± 5.5	66.4 ± 7.3

Sex: Female, Male
Sex: Female, Male(Participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL	Total
Female	10	3	3	7	23
Male	0	4	4	3	11

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL	Total
Hispanic or Latino	4	2	1	0	7
Not Hispanic or Latino	6	5	6	10	27
Unknown or Not Reported	0	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population	Tecnis ZCB00 or ZTC150 IOL	Light Adjustable Lens (LAL) and Light Delivery Device (LDD) - Modified Safety Population	SofPort LI61AO IOL	Total
Race — Caucasian	9	7	7	10	33
Race — Black/African American	1	0	0	0	1
Race — Asian	0	0	0	0	0
Race — American Indian/Alaska Native	0	0	0	0	0
Race — Native Hawaiian/Pacific Islander	0	0	0	0	0
Race — Other	0	0	0	0	0

Study locations

1 site

Vold Vision
Fayetteville, Arkansas 72704, United States

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Oct 12, 2020

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2019 to primary completion in Dec 2021, 25 months.

Results were first posted in Jan 2025, 3 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 22, 2019
First posted: Nov 26, 2019
StartActual: Nov 15, 2019
Primary completionActual: Dec 20, 2021
CompletionActual: Dec 20, 2021
Results first posted: Jan 7, 2025
Last update: Jan 7, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04177771
Lead sponsor: RxSight, Inc.
Responsible party: Sponsor
First posted: Nov 26, 2019
Start date: Nov 15, 2019
Primary completion: Dec 20, 2021
Completion: Dec 20, 2021
Results posted: Jan 7, 2025
Last update: Jan 7, 2025

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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