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

NCT03660865 | Completed Results FDA Device

• 1 other identifier: CSP-027
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 6

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.

Conditions

Aphakia; Cataract

Keywords

Light Adjustable Lens; Intraocular lens; LAL

Outcome Measures

Primary Outcomes (3)

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

  Postop Month 6

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

  Postop Month 6

• 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 Outcomes (2)

• Uncorrected Distance Visual Acuity (UCDVA)

  Postop Month 6

• 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

Study Arms (2)

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

EXPERIMENTAL

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)

Control IOL

ACTIVE COMPARATOR

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

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

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

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

Control IOL DEVICE

Fellow eye will receive control IOL

Control IOL

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RxSight, Inc.: lead

Study Sites (6)

Discover Vision Centers

Leawood, Kansas, 66211, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, 57108, United States

Location

Slade & Baker Vision

Houston, Texas, 77027, United States

Location

Focal Point Vision

San Antonio, Texas, 78229, United States

Location

The Eye Institute of Utah

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Aphakia; Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Jeffrey Ha, Senior Director of Clinical Research
• Organization: RxSight

jha@rxsight.com

949-521-7870

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 7, 2018
• Study Start: August 28, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 23, 2021
• Results First Posted: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)