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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660865
Recruitment Status : Completed
First Posted : September 7, 2018
Results First Posted : November 22, 2021
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
RxSight, Inc.

Study Description
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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 disease Intervention/treatment Phase
Aphakia Cataract Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) Device: Control IOL Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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 : August 28, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020
Arms and Interventions
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Arm Intervention/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
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Primary Outcome Measures :
  1. Magnitude of Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control [ Time Frame: Postop Month 6 ]
  2. Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control [ Time Frame: 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% [ Time Frame: Postop Month 6 ]

Secondary Outcome Measures :
  1. Uncorrected Distance Visual Acuity (UCDVA) [ Time Frame: 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 [ Time Frame: Postop Month 6 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660865


Locations
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United States, Kansas
Discover Vision Centers
Leawood, Kansas, United States, 66211
United States, Ohio
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141
United States, South Dakota
Vance Thompson Vision Clinic
Sioux Falls, South Dakota, United States, 57108
United States, Texas
Slade & Baker Vision
Houston, Texas, United States, 77027
Focal Point Vision
San Antonio, Texas, United States, 78229
United States, Utah
The Eye Institute of Utah
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
RxSight, Inc.
  Study Documents (Full-Text)

Documents provided by RxSight, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 3, 2019

More Information
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Responsible Party: RxSight, Inc.
ClinicalTrials.gov Identifier: NCT03660865    
Other Study ID Numbers: CSP-027
First Posted: September 7, 2018    Key Record Dates
Results First Posted: November 22, 2021
Last Update Posted: December 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by RxSight, Inc.:
Light Adjustable Lens
Intraocular lens
LAL
Additional relevant MeSH terms:
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Cataract
Aphakia
Lens Diseases
Eye Diseases