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)

Cataract Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005586
• Other study ID #: CSP-034
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2021
• Source: RxSight, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Cataract

Intervention

Device:
• Light Delivery Device (LDD)
Study eye will undergo Light delivery Device treatments

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Brecksville	Ohio
United States	Vance Thompson Vision Clinic	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
RxSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: ISO 11979-7 Number of Eyes With Ocular Adverse Events (Device Related and Unrelated)	Number of study eyes experiencing Ocular adverse events (device related and unrelated)	Through study completion, an average of 3 months
Primary	Mean Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups		Post Op Month 3
Primary	Change in Manifest Refraction Cylinder (MRCYL) Compared Between the Three Study Groups, LAL Treatment Group and Historical Control Groups		Post Op Month 3