Back to resultsExploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Primary Purpose
Aphakia, Cataract
Status
Completed
Phase
Locations
Mexico
Study Type
Interventional
Intervention
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Light Adjustable Lens, Intraocular lens, LAL
Eligibility 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 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 pseudoexfoliation.
- 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
Sites / Locations
- CODET Vision Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Arm Description
Outcomes
Primary Outcome Measures
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03895034
Brief Title
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Official Title
A Single Center Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RxSight, Inc.
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
Light Adjustable Lens, Intraocular lens, LAL
7. Study Design
Primary Purpose
Treatment
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Intervention Description
Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
Primary Outcome Measure Information:
Title
Percent of Eyes With Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better
Time Frame
3 months post op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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 pseudoexfoliation.
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
Facility Information:
Facility Name
CODET Vision Institute
City
Tijuana
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes
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