Clinical trial NCT04005586: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Cataract
Keywords: Light Delivery Device
LDD
Intraocular lens
Light Adjustable Lens
LAL
Lead sponsor: RxSight, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-02
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive the same treatment
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
timeFrame: Post Op Month 3
measure: Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups
timeFrame: Post Op Month 3
Secondary outcomes:
Other outcomes:
measure: Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)
timeFrame: Through study completion, an average of 3 months
Locations:
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Sioux Falls
country: United States
facility: Vance Thompson Vision Clinic
state: South Dakota
Study officials:
References: