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RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

Primary Purpose

Aphakia, Cataract

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Control IOL
Sponsored by
RxSight, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia focused on measuring Light Adjustable Lens, LAL, Intraocular lens

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Vold VisionRecruiting
  • Reeve Woods Eye CenterRecruiting
  • The Eye Institute of West FloridaRecruiting
  • Newsom EyeRecruiting
  • Discover Vision Centers
  • Vance Thompson VisionRecruiting
  • Vance Thompson VisionRecruiting
  • Center for SightRecruiting
  • Cleveland Eye ClinicRecruiting
  • Carolina Eyecare Physicians, LLCRecruiting
  • Vance Thompson Vision ClinicRecruiting
  • Key-Whitman Eye CenterRecruiting
  • Slade & Baker VisionRecruiting
  • Texas Eye Research CenterRecruiting
  • Focal Point VisionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Control IOL

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of endothelial cell density loss
Rate of retinal findings

Full Information

First Posted
December 29, 2021
Last Updated
August 24, 2023
Sponsor
RxSight, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05202808
Brief Title
RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study
Official Title
RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RxSight, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
Light Adjustable Lens, LAL, Intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized 2:1 to undergo experimental or control treatment.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Arm Type
Experimental
Arm Title
Control IOL
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Intervention Description
Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
Intervention Type
Device
Intervention Name(s)
Control IOL
Intervention Description
Control treatment group will receive a Control IOL
Primary Outcome Measure Information:
Title
Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control
Time Frame
Postop Month 6
Title
Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control
Time Frame
Postop Month 6
Secondary Outcome Measure Information:
Title
Rate of endothelial cell density loss
Time Frame
Postop Month 6
Title
Rate of retinal findings
Time Frame
Postop Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David B Goffredo
Phone
9494215463
Email
dgoffredo@rxsight.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen O'Connell
Phone
978-207-1245
Email
moconnell@rxsight.com
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Department
Phone
479-435-6440
First Name & Middle Initial & Last Name & Degree
Steven Vold, MD
Facility Name
Reeve Woods Eye Center
City
Chico
State/Province
California
ZIP/Postal Code
95926
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Chauvin
Phone
530-899-2244
Ext
131
Email
emma@reevewoods.com
First Name & Middle Initial & Last Name & Degree
David J Woods, MD
Facility Name
The Eye Institute of West Florida
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renee Bondurant, BS
Phone
727-581-8706
Ext
1131
First Name & Middle Initial & Last Name & Degree
Robert Weinstock, M.D.
Facility Name
Newsom Eye
City
Sebring
State/Province
Florida
ZIP/Postal Code
33870
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiomara Marcano
Phone
863-385-1544
Ext
107
Email
x.marcano@newsomeye.net
First Name & Middle Initial & Last Name & Degree
Hunter Newsom, MD
Facility Name
Discover Vision Centers
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Withdrawn
Facility Name
Vance Thompson Vision
City
Alexandria
State/Province
Minnesota
ZIP/Postal Code
56308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abby Garofalo
Phone
320-335-2973
Email
abby.garofalo@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Miranda Danielson
Email
miranda.danielson@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Deborah Ristvedt, DO
Facility Name
Vance Thompson Vision
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Hartnett, CCRC
Phone
402-506-9970
Email
sarah.hartnett@vancethompsonvision.com
First Name & Middle Initial & Last Name & Degree
Brandon Baartman, MD
Facility Name
Center for Sight
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Research Manager
Phone
702-724-2005
First Name & Middle Initial & Last Name & Degree
Eva Liang, MD
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Kus-Kreidler
Phone
216-503-6535
Email
ekus-kreidler@clevelandeyeclinic.com
First Name & Middle Initial & Last Name & Degree
William F Wiley, MD
Facility Name
Carolina Eyecare Physicians, LLC
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helga Sandoval
Phone
843-881-3937
Email
hps@cepmd.com
First Name & Middle Initial & Last Name & Degree
Kerry D Solomon, MD
Facility Name
Vance Thompson Vision Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elle Malmanger, CRC
Phone
605-361-3937
First Name & Middle Initial & Last Name & Degree
Vance Thompson, MD, FACS
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Bittermann
Phone
214-754-0000
Ext
2295
Email
Alex.Bittermann@keywhitman.com
First Name & Middle Initial & Last Name & Degree
Jeffrey Whitman, MD
Facility Name
Slade & Baker Vision
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Department
Phone
713-626-5544
First Name & Middle Initial & Last Name & Degree
Steven Slade, MD, FACS
Facility Name
Texas Eye Research Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barrett Bott
Phone
817-540-6060
Ext
2060
Email
bbott@lasikdr.com
First Name & Middle Initial & Last Name & Degree
Jerry Hu, MD
Facility Name
Focal Point Vision
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Navarro
Phone
210-614-3600
Ext
118
Email
navarro@focalpointvision.com
First Name & Middle Initial & Last Name & Degree
James D Lehmann, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

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