ClinicalTrials.gg
CompletedNCT03729024Updated Aug 6, 2021Results posted

Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

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 2021-08-06.

Sponsored by RxSight, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2018, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

02

Conditions studied

  • Aphakia
  • Cataract

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Keywords

  • Light Adjustable Lens
  • Intraocular lens
  • LAL
03

In context

Aphakia

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

This study's enrollment of 21 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.

04

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 preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
  • 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 zonular laxity or dehiscence.
  • Study eye with pseudoexfoliation.
  • Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 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)

    Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

06

What researchers measure

Primary outcomes

  1. Percent of Eyes With UCDVA of 20/20 or Better

    Time frame: 6 months

07

Results

Posted May 19, 2021

Participant flow

Participant flow — Overall Study
MilestoneLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Started21
Completed21
Not completed0

Outcome measures

PrimaryPercent of Eyes With UCDVA of 20/20 or Better
Time frame:
6 months
Reported as:
Count of units · Eyes
Percent of Eyes With UCDVA of 20/20 or Better
EyesLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Percent of Eyes With UCDVA of 20/20 or Better41

Adverse events

Collected over Through study completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)0/21 (0%)0/42 (0%)1/42 (2.4%)
Most frequent other events
Most frequent other events
EventLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Cystoid Macular EdemaEye disorders1/42

Baseline characteristics

Age, Continuous
Age, Continuous(years)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Mean68.3 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Female12
Male9
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Hispanic or Latino18
Not Hispanic or Latino3
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
Mexico21
08

Study locations

1 site
  • CODET Vision Institute
    Tijuana, Mexico
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03729024
Lead sponsor
RxSight, Inc.
Responsible party
Sponsor
First posted
Nov 2, 2018
Start date
Jan 26, 2018
Primary completion
Apr 15, 2019
Completion
Feb 4, 2020
Results posted
May 19, 2021
Last update
Aug 6, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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