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CompletedNCT03660865Updated Dec 23, 2021Results posted

Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

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 6 sites in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-23.

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

Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study summary

The primary objective of this study is to evaluate, for the visual correction of aphakia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes implanted with a commercially available IOL will be used to compare the safety and effectiveness of the LAL.

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 105 is close to 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 the bilateral implantation of an intraocular lens (IOL).
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK more than 1 year prior in both eyes.
  • Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level 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:

  • Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE), or Corneal Inlay in either eye.
  • 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.
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
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

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

    A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's primary eye will receive the light adjustable lens.

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

  • Active comparator
    Control IOL

    A pre-determined randomization scheme will be utilized to designate each of the patient's eyes as the primary eye (LAL) or the fellow eye (Control). Patient's fellow eye will receive the control IOL.

    Device: Control IOL

Interventions

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

    Primary eye will receive Light adjustable lens with Light delivery Device treatments

  • DeviceControl IOL

    Fellow eye will receive control IOL

06

What researchers measure

Primary outcomes

  1. Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control

    Time frame: Postop Month 6

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

    Time frame: Postop Month 6

  3. One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%

    Time frame: Postop Month 6

Secondary outcomes

  1. Uncorrected Distance Visual Acuity (UCDVA)

    Time frame: Postop Month 6

  2. Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination

    Time frame: Postop Month 6

07

Results

Posted Nov 22, 2021

Participant flow

Participant flow — Overall Study
MilestoneLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Started105105
Completed105105
Not completed00

Outcome measures

PrimaryMagnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time frame:
Postop Month 6
Reported as:
Mean · Diopter
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
DiopterLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control-0.319 ± 0.319-0.452 ± 0.456
PrimaryAbsolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time frame:
Postop Month 6
Reported as:
Mean · Diopter
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
DiopterLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control0.269 ± 0.2690.379 ± 0.338
PrimaryOne Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
Time frame:
Postop Month 6
Reported as:
Number · percent of eyes w. BCDVA 20/40 or better
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%
percent of eyes w. BCDVA 20/40 or betterLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
One Sided Upper 95% Confidence Limit of the Percentage of LAL Implanted Eyes With BCDVA of 20/40 or Better is Higher Than the Performance Rate of 92.5%100 (100 to 100)
SecondaryUncorrected Distance Visual Acuity (UCDVA)
Time frame:
Postop Month 6
Reported as:
Mean · logMAR
Uncorrected Distance Visual Acuity (UCDVA)
logMARLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Uncorrected Distance Visual Acuity (UCDVA)0.002 ± 0.1080.052 ± 0.130
SecondaryUncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Time frame:
Postop Month 6
Reported as:
Mean · mean logMAR UCDVA
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
mean logMAR UCDVALight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Uncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination-0.003 ± 0.1130.061 ± 0.139

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)0/105 (0%)1/105 (1%)48/105 (45.7%)
Control IOL0/105 (0%)0/105 (0%)38/105 (36.2%)
Most frequent serious events
Most frequent serious events
EventLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Secondary Surgical Intervention (excluding Posterior Capsulotomy)Eye disorders1/1050/105
Clinically significant Cystoid Macular EdemaEye disorders0/1050/105
Most frequent other events
Showing 10 of 26
Most frequent other events
EventLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
YAG performed to treat posterior capsular opacityEye disorders27/10520/105
Ocular discomfortEye disorders3/1051/105
Anterior Chamber InflammationEye disorders2/1052/105
Corneal EdemaEye disorders2/1050/105
Epithelial defectEye disorders0/1052/105
Light sensitivityEye disorders2/1052/105
Loss of BCDVA of >/= 10 letters (when compared to Preoperative or Postop Week 3 BCDVA)Eye disorders1/1050/105
Removal of retained CortexEye disorders0/1051/105
Conjunctival hyperemiaEye disorders1/1050/105
Conjunctival hyperemia/edemaEye disorders1/1051/105

Baseline characteristics

Age, Continuous
Age, Continuous(years)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Mean64.2 ± 6.964.2 ± 6.964.2 ± 6.9
Sex: Female, Male
Sex: Female, Male(Eyes)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Female6060120
Male454590
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Eyes)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Hispanic or Latino121224
Not Hispanic or Latino9393186
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Eyes)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White105105210
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Eyes)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
United States105105210
Eye
Eye(Eyes)Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
OD Eye5253105
OS Eye5352105
08

Study locations

6 sites
  • Discover Vision Centers
    Leawood, Kansas 66211, United States
  • Cleveland Eye Clinic
    Brecksville, Ohio 44141, United States
  • Vance Thompson Vision Clinic
    Sioux Falls, South Dakota 57108, United States
  • Slade & Baker Vision
    Houston, Texas 77027, United States
  • Focal Point Vision
    San Antonio, Texas 78229, United States
  • The Eye Institute of Utah
    Salt Lake City, Utah 84107, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

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 Aug 2018 to primary completion in Apr 2020, 19 months.

Results were first posted in Nov 2021, 1 year 7 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 19 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
Aug 29, 2018
First posted
Sep 7, 2018
StartActual
Aug 28, 2018
Primary completionActual
Apr 1, 2020
CompletionActual
Apr 1, 2020
Results first posted
Nov 22, 2021
Last update
Dec 23, 2021
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 Dec 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03660865
Lead sponsor
RxSight, Inc.
Responsible party
Sponsor
First posted
Sep 7, 2018
Start date
Aug 28, 2018
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Results posted
Nov 22, 2021
Last update
Dec 23, 2021

Oversight

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

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

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