Back to resultsA Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
Primary Purpose
Aphakia, Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Light Delivery Device (LDD)
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Light Delivery Device, LDD, Intraocular lens, Light Adjustable Lens, LAL
Eligibility Criteria
Inclusion Criteria:
- A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
- A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
- Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
- Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
- Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
- Willing and able to comply with the requirements for study specific procedures and visits
Exclusion Criteria:
- Pre-existing macular disease in the study eye.
- History of uveitis in the study eye.
- Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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 the study eye.
- Subject who has participated within another ophthalmic clinical trial within the last 3 months.
- Sutures used at the time of surgery to close the incision wound in the study eye
Sites / Locations
- Cleveland Eye Clinic
- Vance Thompson Vision Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Light Delivery Device (LDD)
Arm Description
Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Outcomes
Primary Outcome Measures
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04005586
Brief Title
A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
Official Title
A Prospective Controlled Multi-Center Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the safety and effectiveness of performing 0.50 D cylinder correction on the RxSight Light Adjustable Lens (LAL) in patients who have undergone implantation with the FDA approved, commercially available LAL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Cataract
Keywords
Light Delivery Device, LDD, Intraocular lens, Light Adjustable Lens, LAL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive the same treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Light Delivery Device (LDD)
Arm Type
Experimental
Arm Description
Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Intervention Type
Device
Intervention Name(s)
Light Delivery Device (LDD)
Intervention Description
Study eye will undergo Light delivery Device treatments
Primary Outcome Measure Information:
Title
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time Frame
Post Op Month 3
Title
Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time Frame
Post Op Month 3
Other Pre-specified Outcome Measures:
Title
Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)
Description
Number of study eyes experiencing Ocular adverse events (device related and unrelated)
Time Frame
Through study completion, an average of 3 months
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:
A study eye implanted with the commercially approved LAL that has not undergone any previous LDD treatments
A study eye with manifest refraction cylinder of 0.50 D measured by two independent examiners at the Adjustment #1 visit prior to the first light adjustment treatment.
Sign a written Informed Consent form and be willing to receive light treatment for their 0.50 D of cylinder.
Between the ages of 40 and 80 inclusive on the day the informed consent form is signed.
Good vision in the fellow eye with best corrected distance visual acuity (BCDVA) 20/40 or better.
Willing and able to comply with the requirements for study specific procedures and visits
Exclusion Criteria:
Pre-existing macular disease in the study eye.
History of uveitis in the study eye.
Has undergone previous corneal or intraocular surgery in the study eye, except for the cataract surgery and 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 the study eye.
Subject who has participated within another ophthalmic clinical trial within the last 3 months.
Sutures used at the time of surgery to close the incision wound in the study eye
Facility Information:
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Vance Thompson Vision Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study to Evaluate The Safety and Effectiveness of Performing 0.50 Diopter Astigmatism Correction on the Commercially Available RxSight Light Adjustable Lens (LAL)
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