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

Sponsor
RxSight, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03660865
Collaborator
(none)
105
Enrollment
6
Locations
2
Arms
19.1
Actual Duration (Months)
17.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
  • Device: Control IOL
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.All subjects will receive the same treatment; however, each subject will have their eyes randomized to receive the experimental treatment in either the left/right eye. The control will then be assigned to the other.
Masking:
None (Open Label)
Masking Description:
Select post operative assessments will be performed on both the experimental and control eye by an examiner who will be masked to the eye assignments.
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
Actual Study Start Date :
Aug 28, 2018
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

ArmIntervention/Treatment
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)
Primary eye will receive Light adjustable lens with Light delivery Device treatments

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
Fellow eye will receive control IOL

Outcome Measures

Primary Outcome Measures

  1. Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

  2. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control [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% [Postop Month 6]

Secondary Outcome Measures

  1. Uncorrected Distance Visual Acuity (UCDVA) [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 [Postop Month 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Must sign a written Informed Consent 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:
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Discover Vision CentersLeawoodKansasUnited States66211
2Cleveland Eye ClinicBrecksvilleOhioUnited States44141
3Vance Thompson Vision ClinicSioux FallsSouth DakotaUnited States57108
4Slade & Baker VisionHoustonTexasUnited States77027
5Focal Point VisionSan AntonioTexasUnited States78229
6The Eye Institute of UtahSalt Lake CityUtahUnited States84107

Sponsors and Collaborators

  • RxSight, Inc.

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
RxSight, Inc.
ClinicalTrials.gov Identifier:
NCT03660865
Other Study ID Numbers:
  • CSP-027
First Posted:
Sep 7, 2018
Last Update Posted:
Nov 22, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by RxSight, Inc.
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
Period Title: Overall Study
STARTED105105
COMPLETED105105
NOT COMPLETED00

Baseline Characteristics

Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOLTotal
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOLTotal of all reporting groups
Overall Participants105105210
Overall Eyes105105210
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
64.2
(6.9)
64.2
(6.9)
64.2
(6.9)
Sex: Female, Male (Eyes) [Count of Units]
Female
60
60
120
Male
45
45
90
Ethnicity (NIH/OMB) (Eyes) [Count of Units]
Hispanic or Latino
12
12
24
Not Hispanic or Latino
93
93
186
Unknown or Not Reported
0
0
0
Race (NIH/OMB) (Eyes) [Count of Units]
American Indian or Alaska Native
0
0
0
Asian
0
0
0
Native Hawaiian or Other Pacific Islander
0
0
0
Black or African American
0
0
0
White
105
105
210
More than one race
0
0
0
Unknown or Not Reported
0
0
0
Region of Enrollment (Eyes) [Number]
United States
105
105
210
Eye (Eyes) [Count of Units]
OD Eye
52
53
105
OS Eye
53
52
105

Outcome Measures

1. Primary Outcome
TitleMagnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Description
Time FramePostop Month 6

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
Measure Participants105105
Measure Eyes105105
Mean (Standard Deviation) [Diopter]
-0.319
(0.319)
-0.452
(0.456)
2. Primary Outcome
TitleAbsolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Description
Time FramePostop Month 6

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
Measure Participants105105
Measure Eyes105105
Mean (Standard Deviation) [Diopter]
0.269
(0.269)
0.379
(0.338)
3. Primary Outcome
TitleOne 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%
Description
Time FramePostop Month 6

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatments
Measure Participants105
Measure Eyes105
Number (95% Confidence Interval) [percent of eyes w. BCDVA 20/40 or better]
100
4. Secondary Outcome
TitleUncorrected Distance Visual Acuity (UCDVA)
Description
Time FramePostop Month 6

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
Measure Participants105105
Measure Eyes105105
Mean (Standard Deviation) [mean logMAR UCDVA]
0.002
(0.108)
0.052
(0.130)
5. Secondary Outcome
TitleUncorrected Distance Visual Acuity (UCDVA) for Subjects Measured With Keratometric Cylinder (Kcyl) <0.75 D in Both Eyes at the Preoperative Examination
Description
Time FramePostop Month 6

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
Measure Participants4242
Measure Eyes4242
Mean (Standard Deviation) [mean logMAR UCDVA]
-0.003
(0.113)
0.061
(0.139)

Adverse Events

Time FrameThrough study completion, an average of 6 months
Adverse Event Reporting Description Non-ocular, Non-serious adverse events were not required to be collected per protocol. All-Cause Mortality and Non-Ocular Serious Adverse Events are reported at the participants level. Ocular Serious and Other (Not Including Serious) Adverse Events are presented with total number of eyes monitored/assessed as the at Risk population.
Arm/Group TitleLight Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Arm/Group DescriptionA 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. Light Adjustable lens (LAL) and Light Delivery Device (LDD): Primary eye will receive Light adjustable lens with Light delivery Device treatmentsA 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. Control IOL: Fellow eye will receive control IOL
All Cause Mortality
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/105 (0%) 0/105 (0%)
Serious Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/105 (1%) 0/105 (0%)
Eye disorders
Clinically significant Cystoid Macular Edema0/105 (0%) 00/105 (0%) 0
Secondary Surgical Intervention (excluding Posterior Capsulotomy)1/105 (1%) 10/105 (0%) 0
Other (Not Including Serious) Adverse Events
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)Control IOL
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total48/105 (45.7%) 38/105 (36.2%)
Eye disorders
Anterior Chamber Inflammation2/105 (1.9%) 22/105 (1.9%) 2
Corneal Edema2/105 (1.9%) 20/105 (0%) 0
Loss of BCDVA of >/= 10 letters (when compared to Preoperative or Postop Week 3 BCDVA)1/105 (1%) 10/105 (0%) 0
Removal of retained Cortex0/105 (0%) 01/105 (1%) 1
Conjunctival hyperemia1/105 (1%) 10/105 (0%) 0
Conjunctival hyperemia/edema1/105 (1%) 11/105 (1%) 1
Corneal SPK1/105 (1%) 10/105 (0%) 0
Double vision1/105 (1%) 11/105 (1%) 1
Epiretinal membrane0/105 (0%) 01/105 (1%) 1
Epithelial basement membrane dystrophy appearance1/105 (1%) 10/105 (0%) 0
Epithelial defect0/105 (0%) 02/105 (1.9%) 2
Glare at night0/105 (0%) 01/105 (1%) 1
Iris atrophy/Medication deposits1/105 (1%) 10/105 (0%) 0
Iris prolapse1/105 (1%) 10/105 (0%) 0
Light sensitivity2/105 (1.9%) 22/105 (1.9%) 2
Non-clinically significant cystoid macular edema0/105 (0%) 01/105 (1%) 1
Ocular discomfort3/105 (2.9%) 31/105 (1%) 1
Posterior vitreous detachment0/105 (0%) 01/105 (1%) 1
Retained cortex0/105 (0%) 01/105 (1%) 1
Vision doesn't fuse together for distance well1/105 (1%) 10/105 (0%) 0
Vitreous hemorrhage0/105 (0%) 01/105 (1%) 1
Vitreous in anterior chamber0/105 (0%) 01/105 (1%) 1
YAG performed to treat capsular phemosis1/105 (1%) 10/105 (0%) 0
YAG performed to treat capsular striae1/105 (1%) 10/105 (0%) 0
YAG performed to treat posterior capsular opacity27/105 (25.7%) 2720/105 (19%) 20
YAG performed to treat vitreous strand1/105 (1%) 11/105 (1%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleJeffrey Ha, Senior Director of Clinical Research
OrganizationRxSight
Phone949-521-7870
Emailjha@rxsight.com
Responsible Party:
RxSight, Inc.
ClinicalTrials.gov Identifier:
NCT03660865
Other Study ID Numbers:
  • CSP-027
First Posted:
Sep 7, 2018
Last Update Posted:
Nov 22, 2021
Last Verified:
Oct 1, 2021