Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03660865
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
RxSight, Inc.

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 monofocal 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 monofocal IOL Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

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 monofocal 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 monofocal IOL.
Device: Control monofocal IOL
Fellow eye will receive control monofocal IOL




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
  • Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
  • History of ocular herpes simplex virus in either eye.

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


Contacts
Layout table for location contacts
Contact: David Goffredo 949-421-5463 ext 300 dgoffredo@rxsight.com
Contact: Maureen O'Connell 978-207-1245 moconnell@rxsight.com

Locations
Layout table for location information
United States, Kansas
Discover Vision Centers Recruiting
Leawood, Kansas, United States, 66211
Contact: Clinical Research Coordinator for Dr. John Doane    816-350-6903      
Principal Investigator: John F Doane, MD         
United States, Ohio
Cleveland Eye Clinic Recruiting
Brecksville, Ohio, United States, 44141
Contact: Erin Kus-Kreidler    216-503-6535    ekus-kreidler@clevelandeyeclinic.com   
Principal Investigator: William F Wiley, MD         
United States, South Dakota
Vance Thompson Vision Clinic Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Keeley Puls, Director of Research, CCRC    605-361-3937      
Principal Investigator: Vance Thompson, MD, FACS         
United States, Texas
Slade & Baker Vision Recruiting
Houston, Texas, United States, 77027
Contact: Research Department    713-626-5544      
Principal Investigator: Steven Slade, MD, FACS         
Focal Point Vision Recruiting
San Antonio, Texas, United States, 78229
Contact: Lisa Navarro    210-614-3600 ext 118    navarro@focalpointvision.com   
Principal Investigator: James D Lehmann, MD         
United States, Utah
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Laurie Adams    801-266-2283      
Principal Investigator: Robert J Cionni, MD         
Sponsors and Collaborators
RxSight, Inc.

Layout table for additonal information
Responsible Party: RxSight, Inc.
ClinicalTrials.gov Identifier: NCT03660865     History of Changes
Other Study ID Numbers: CSP-027
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by RxSight, Inc.:
Light Adjustable Lens
Intraocular lens
LAL

Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Aphakia
Lens Diseases
Eye Diseases