NCT04005586CompletedNot Applicable
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RxSight, Inc.
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Light Delivery Device (LDD)
Experimental
Patient's study eye will undergo light delivery treatments to the commercially available light adjustable lens.
Intervention: Light Delivery Device (LDD) (Device)
Outcomes
Primary Outcomes
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
Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
Time Frame: Post Op Month 3
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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