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

Primary Purpose

Aphakia, Cataract

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

Control IOL

About this trial

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

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 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.

Sites / Locations

Discover Vision Centers
Cleveland Eye Clinic
Vance Thompson Vision Clinic
Slade & Baker Vision
Focal Point Vision
The Eye Institute of Utah

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

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.

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.

Outcomes

Primary Outcome Measures

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

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

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%

Secondary Outcome Measures

Uncorrected Distance Visual Acuity (UCDVA)

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

Full Information

NCT ID

NCT03660865

First Posted

August 29, 2018

Last Updated

November 22, 2021

Sponsor

RxSight, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03660865

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

August 28, 2018 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

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

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. 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.

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, Intraocular lens, LAL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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.

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.

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

Control IOL

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Control IOL

Intervention Description

Fellow eye will receive control IOL

Primary Outcome Measure Information:

Title

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

Time Frame

Postop Month 6

Title

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

Time Frame

Postop Month 6

Title

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 Outcome Measure Information:

Title

Uncorrected Distance Visual Acuity (UCDVA)

Time Frame

Postop Month 6

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Discover Vision Centers

City

Leawood

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Cleveland Eye Clinic

City

Brecksville

State/Province

Ohio

ZIP/Postal Code

44141

Country

United States

Facility Name

Vance Thompson Vision Clinic

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57108

Country

United States

Facility Name

Slade & Baker Vision

City

Houston

State/Province

Texas

ZIP/Postal Code

77027

Country

United States

Facility Name

Focal Point Vision

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

The Eye Institute of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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