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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

NCT ID: NCT03660865

Last Updated: 2021-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2020-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aphakia Cataract

Keywords

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Light Adjustable Lens Intraocular lens LAL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Control IOL

Intervention Type DEVICE

Fellow eye will receive control IOL

Interventions

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

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

Intervention Type DEVICE

Control IOL

Fellow eye will receive control IOL

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RxSight, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Discover Vision Centers

Leawood, Kansas, United States

Site Status

Cleveland Eye Clinic

Brecksville, Ohio, United States

Site Status

Vance Thompson Vision Clinic

Sioux Falls, South Dakota, United States

Site Status

Slade & Baker Vision

Houston, Texas, United States

Site Status

Focal Point Vision

San Antonio, Texas, United States

Site Status

The Eye Institute of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CSP-027

Identifier Type: -

Identifier Source: org_study_id