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CompletedNCT05202808Updated Apr 20, 2025Results posted

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

An interventional study of Light Adjustable lens (LAL) and Light Delivery Device (LDD) and Control IOL in Aphakia and Cataract, sponsored by RxSight, Inc.. Completed at 14 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-20.

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

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The primary objective of this study is to conduct a post-approval study which compares the LAL to a monofocal control IOL for safety outcomes.

02

Conditions studied

  • Aphakia
  • Cataract

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Keywords

  • Light Adjustable Lens
  • LAL
  • Intraocular lens
03

Who can participate

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

Inclusion criteria

  • Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • 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.
  • Patients with sufficiently dense cataracts that preclude examination of the macula in either eye.
  • History of uveitis in either eye.
  • Evidence of ectasia in either eye.
  • Previous intraocular surgery in either eye. 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.
  • Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
  • History of ocular herpes simplex virus in either eye.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    Light adjustable lens (LAL) and Light Delivery Device (LDD)

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

  • Active comparator
    Control IOL

    Device: Control IOL

Interventions

  • DeviceLight Adjustable lens (LAL) and Light Delivery Device (LDD)

    Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments

  • DeviceControl IOL

    Control treatment group will receive a Control IOL

05

What researchers measure

Primary outcomes

  1. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control

    Time frame: Postop Month 6

  2. Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

    Time frame: Postop Month 6

Secondary outcomes

  1. Rate of Endothelial Cell Density Loss

    The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.

    Time frame: Postop Month 6

  2. Rate of Retinal Findings

    Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

    Time frame: Postop Month 6

06

Results

Posted Apr 20, 2025

Participant flow

Participant flow — Overall Study
MilestoneLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Started335165
Completed332164
Not completed31
Withdrew: Lost to follow-up31

Outcome measures

PrimaryAbsolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame:
Postop Month 6
Reported as:
Mean · Diopters
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
DioptersLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control0.210 ± 0.2130.345 ± 0.265
PrimaryAbsolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame:
Postop Month 6
Reported as:
Mean · Diopters
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
DioptersLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control0.262 ± 0.2750.820 ± 0.554
SecondaryRate of Endothelial Cell Density Loss

The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.

Time frame:
Postop Month 6
Reported as:
Median · percentage Endothelial Cell Change
Rate of Endothelial Cell Density Loss
percentage Endothelial Cell ChangeLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Rate of Endothelial Cell Density Loss5.1 (3.8 to 7.0)4.9 (3.0 to 6.5)
Statistical analysis
  • Light Adjustable Lens (LAL) and Light Delivery Device (LDD) vs Control IOL · Wilcoxon (Mann-Whitney) · p = <0.0001 · Median difference (final values): 0.2 · 90% CI -1.00 to 1.66
SecondaryRate of Retinal Findings

Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

Time frame:
Postop Month 6
Reported as:
Count of participants · Participants
Rate of Retinal Findings
ParticipantsLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Rate of Retinal Findings0
Post-hocOdds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group

Success defined as UCDVA 20/20 or better, failure defined as UCDVA worse than 20/20. Odds defined as number of successes divided by number of failures.

Time frame:
6 months
Reported as:
Count of participants · Participants
Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group
ParticipantsLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
UCDVA 20/20 or better27483
UCDVA worse than 20/205881
Statistical analysis
  • Light Adjustable Lens (LAL) and Light Delivery Device (LDD) vs Control IOL · Odds ratio (or): 4.61 · 95% CI 2.97 to 7.15Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and Control group is the denominator. At Month 6, the odds of achieving UCDVA of 20/20 or better were 4.61 times greater for the LAL group than the Control group.
Post-hocOdds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group
Time frame:
6 months
Reported as:
Count of participants · Participants
Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group
ParticipantsLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Absolute MRCYL 0.50 D or less30761
Absolute MCRYL worse than 0.50 D25103
Statistical analysis
  • Light Adjustable Lens (LAL) and Light Delivery Device (LDD) vs Control IOL · Odds ratio (or): 20.74 · 95% CI 12.05 to 36.14Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving Absolute MRCYL of 0.5D or less was 20.74 for the LAL group versus the Control group at month 6.
Post-hocOdds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group
Time frame:
6 months
Reported as:
Count of participants · Participants
Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group
ParticipantsLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Simultaneous absolute MRSE and absolute MRCYL of 0.50 D or less29154
Simultaneous absolute MRSE and absolute MRCYL worse than 0.50 D41110
Statistical analysis
  • Light Adjustable Lens (LAL) and Light Delivery Device (LDD) vs Control IOL · Odds ratio (or): 14.46 · 95% CI 8.89 to 23.57Light adjustable lens (LAL) and Light Delivery Device (LDD) group is the numerator and the Control group is the denominator. The odds of achieving simultaneous Absolute MRSE and MRCL of 0.5 D or less was 14.46 in the LAL group vs. Control at month 6.

Adverse events

Collected over 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)0/335 (0%)7/335 (2.1%)71/335 (21.2%)
Control IOL0/165 (0%)2/165 (1.2%)26/165 (15.8%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Secondary Surgical Intervention: Intraocular Lens ExchangeSurgical and medical procedures0/3351/165
Inpatient hospitalization for Ventral Hernia Repair SurgerySurgical and medical procedures0/3351/165
Inpatient hospitalization due to PneumoniaInfections and infestations0/3351/165
Secondary Surgical Intervention: Iris Repositioning following prolapseSurgical and medical procedures1/3350/165
Secondary Surgical Intervention: Study Eye, Selective Laser TrabeculoplastySurgical and medical procedures1/3350/165
Secondary Surgical Intervention: Non-Study Eye Intraocular Lens ExchangeSurgical and medical procedures1/3350/165
Non-Study Eye, Full Thickness Macular HoleEye disorders1/3350/165
Secondary Surgical Intervention: Non-Study Eye, Macular Hole RepairSurgical and medical procedures1/3350/165
Inpatient hospitalization following Hip Replacement SurgeryInjury, poisoning and procedural complications1/3350/165
Inpatient hospitalization due to Salmonella InfectionInfections and infestations1/3350/165
Most frequent other events
Showing 10 of 46
Most frequent other events
EventLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Superficial Punctate KeratitisEye disorders16/3352/165
Raised IOPEye disorders14/3355/165
Anterior Chamber InflammationEye disorders6/3356/165
Clinically significant cystoid macular edemaEye disorders2/3354/165
Loss of BCDVA of >= 10 letters (when compared to Preop and/or Postop Week 3 BCDVA)Eye disorders2/3354/165
Dry Eye SyndromeEye disorders7/3350/165
Hypertensive RetinopathyEye disorders1/3352/165
Corneal AbrasionEye disorders4/3351/165
Raised IOP >=10 mmHg above preop & >=25 mmHg (if present > Week 1), unrelated to mech. pupil. blockEye disorders3/3350/165
Conjunctival CystEye disorders0/3351/165

Baseline characteristics

Age, Continuous
Age, Continuous(years)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Mean67.3 ± 6.967.1 ± 6.367.1 ± 6.8
Sex: Female, Male
Sex: Female, Male(Participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Female227106333
Male10859167
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
American Indian or Alaska Native123
Asian628
Black or African American23831
Native Hawaiian or Other Pacific Islander112
Caucasian305156461
Region of Enrollment
Region of Enrollment(participants)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
United States335165500
07

Study locations

14 sites
  • Vold Vision
    Fayetteville, Arkansas 72704, United States
  • Reeve Woods Eye Center
    Chico, California 95926, United States
  • The Eye Institute of West Florida
    Largo, Florida 33770, United States
  • Newsom Eye
    Sebring, Florida 33870, United States
  • Vance Thompson Vision
    Alexandria, Minnesota 56308, United States
  • Vance Thompson Vision
    Omaha, Nebraska 68137, United States
  • Center for Sight
    Las Vegas, Nevada 89145, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, United States
  • Carolina Eyecare Physicians, LLC
    Mount Pleasant, South Carolina 29464, United States
  • Vance Thompson Vision Clinic
    Sioux Falls, South Dakota 57108, United States
  • Key-Whitman Eye Center
    Dallas, Texas 75235, United States
  • Slade &amp; Baker Vision
    Houston, Texas 77027, United States
  • Texas Eye Research Center
    Hurst, Texas 76054, United States
  • Focal Point Vision
    San Antonio, Texas 78229, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 20, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT05202808
Lead sponsor
RxSight, Inc.
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Dec 3, 2021
Primary completion
Sep 11, 2024
Completion
Dec 16, 2024
Results posted
Apr 20, 2025
Last update
Apr 20, 2025

Oversight

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

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