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Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

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: NCT03729024
Recruitment Status : Completed
First Posted : November 2, 2018
Results First Posted : May 19, 2021
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
RxSight, Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

Condition or disease Intervention/treatment Phase
Aphakia Cataract Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will receive the same treatment; however, each subject will have their eyes randomized to primary or fellow assignment. If only one eye of a patient meets study eligibility, that eye will automatically be designated as the primary eye.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
Actual Study Start Date : January 26, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : February 4, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Light adjustable lens (LAL) and Light Delivery Device (LDD) Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments


Outcome Measures
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Primary Outcome Measures :
  1. Percent of Eyes With UCDVA of 20/20 or Better [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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 unilateral or bilateral implantation of the RxLAL.
  • Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
  • Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D.
  • Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
  • Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

  • Study eye with zonular laxity or dehiscence.
  • Study eye with pseudoexfoliation.
  • Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
  • Study eye with diabetes with any evidence of retinopathy.
  • Study eye with evidence of glaucomatous optic neuropathy.
  • Study eye with history of uveitis.
  • Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.
  • Study eye with history of ocular herpes simplex virus.
  • Study eye with history of a congenital color vision defect
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): NCT03729024


Locations
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Mexico
CODET Vision Institute
Tijuana, Mexico
Sponsors and Collaborators
RxSight, Inc.
  Study Documents (Full-Text)

Documents provided by RxSight, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] April 27, 2018

More Information
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Responsible Party: RxSight, Inc.
ClinicalTrials.gov Identifier: NCT03729024    
Other Study ID Numbers: CSP-028
First Posted: November 2, 2018    Key Record Dates
Results First Posted: May 19, 2021
Last Update Posted: August 6, 2021
Last Verified: August 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
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by RxSight, Inc.:
Light Adjustable Lens
Intraocular lens
LAL
Additional relevant MeSH terms:
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Cataract
Astigmatism
Aphakia
 Lens Diseases
Eye Diseases
Refractive Errors