CompletedNCT03895034Updated May 12, 2022Results posted

Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes

An interventional study of Light Adjustable lens (LAL) and Light Delivery Device (LDD) in Aphakia and Cataract, sponsored by RxSight, Inc.. Completed at 1 site in Mexico. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-05-12.

Sponsored by RxSight, Inc. · Interventional and Treatment

From the registry’s dates

Registered 9 months after the study started (first participant enrolled Jun 2018, registered Mar 2019).

Study type: Interventional
Enrollment: 66
Allocation: Not applicable
Ages: 40 Years to 80 Years
Sex: All

Study 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. No primary effectiveness endpoints will be identified.

Conditions studied

Aphakia
Cataract

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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 66 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 unilateral or bilateral implantation of the RxLAL.
Between the ages of 40 and 80 inclusive 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.

Exclusion criteria

Exclusion Criteria:

Study eye with pseudoexfoliation.
Study eye with diabetes with any evidence of retinopathy.
Study eye with evidence of glaucomatous optic neuropathy.
Study eye with history of uveitis.
Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
Study eye with history of ocular herpes simplex virus.
Study eye with history of a congenital color vision defect

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 66 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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

Results

Posted Sep 22, 2021

Participant flow

Participant flow — Overall Study
Milestone	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Started	66
Completed	64
Not completed	2
Withdrew: Lost to follow-up	2

Outcome measures

PrimaryPercent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better

Time frame:: 3 months post op
Reported as:: Count of units · Eyes

Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Eyes	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better	101

Adverse events

Collected over Through study completion, an average of 3 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)	0/66 (0%)	0/111 (0%)	25/111 (22.5%)

Most frequent other events

Most frequent other events
Event	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Superficial Punctate KeratitisEye disorders	11/111
IritisEye disorders	3/111
Corneal GuttataEye disorders	2/111
Posterior Capsular OpacityEye disorders	2/111
Vision changes including night vision changesEye disorders	2/111
Anterior Capsule RuptureEye disorders	1/111
BCDVA Drop of 10 letters of moreEye disorders	1/111
Corneal ErosionEye disorders	1/111
Cystoid Macular EdemaEye disorders	1/111
Iris AtrophyEye disorders	1/111

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Mean	67.4 ± 7.2

Sex: Female, Male
Sex: Female, Male(Participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Female	42
Male	24

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Hispanic	66
White	0
Black	0
Other	0

Region of Enrollment
Region of Enrollment(participants)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Mexico	66

Eyes
Eyes(Eyes)	Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
OD	56
OS	55

Study locations

1 site

CODET Vision Institute
Tijuana, Mexico

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Apr 9, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Mar 2020, 20 months.

Results were first posted in Sep 2021, 1 year 6 months after primary completion.

Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 20 months is above that.

Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.

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

Registered: Mar 27, 2019
First posted: Mar 29, 2019
StartActual: Jun 14, 2018
Primary completionActual: Mar 1, 2020
CompletionActual: Mar 1, 2020
Results first posted: Sep 22, 2021
Last update: May 12, 2022

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 May 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03895034
Lead sponsor: RxSight, Inc.
Responsible party: Sponsor
First posted: Mar 29, 2019
Start date: Jun 14, 2018
Primary completion: Mar 1, 2020
Completion: Mar 1, 2020
Results posted: Sep 22, 2021
Last update: May 12, 2022

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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