Clinical Study to Evaluate the RxSight Light Adjustable Lens With the Light Delivery Device in Subjects With Preoperative Corneal Astigmatism

NCT ID: NCT03771352

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2020-07-01

Brief Summary

For patients undergoing cataract surgery, the purpose of this study is to evaluate a patient's far vision without glasses and quality of vision after implantation and UV treatment of the RxSight Light Adjustable Lens (RxLAL).Following completion of all light treatments, the patient's far vision without glasses and quality of vision will be assessed 6 months postoperatively.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RxSight RxLAL IOL

Eligible patients will be implanted with the RxSight RxLAL intraocular lens (IOL)

Group Type: OTHER

RxSight RxLAL

Intervention Type: DEVICE

The patients will be assessed for 6 months

Interventions

RxSight RxLAL

The patients will be assessed for 6 months

Intervention Type: DEVICE

Other Intervention Names

Light Adjustable Lens; Light Delivery Device

Eligibility Criteria

Inclusion Criteria

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for the bilateral implantation of the RxLAL.
• Greater than the age of 40 on the day the cataract surgery is performed.
• Preoperative keratometric cylinder of >=0.50 D and <=4.00 D in both eyes.
• Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without glare source in both eyes.
• Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria

• Zonular laxity or dehiscence.
• Age-related macular degeneration involving the presence of geographic atrophy or soft drusen.
• Retinal degenerative disorder or macular disorder (other than mild macular degeneration) that is expected to cause future vision loss.
• History of uveitis
• Keratoconus or suspected of having keratoconus.
• Previous corneal or intraocular surgery, except eyes with previous pterygium excision are permitted as long as the pterygium did not extend more than 2mm onto the cornea from the limbus.
• Serious co-morbid conditions that in the judgement of the investigator makes inclusion in the study not in the best interest of the subject.
• Subjects taking systemic medications 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
• History of congenital color vision defect

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RxSight, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Burkhard Dick, MD

Role: PRINCIPAL_INVESTIGATOR

University Eye Clinic- Bochum, Germany

Fritz Hengerer, MD

Role: PRINCIPAL_INVESTIGATOR

University Eye Clinic- Heidelberg, Germany

Sathish Srinivasan, MD

Role: PRINCIPAL_INVESTIGATOR

Ayrshire Eye Clinic and Laser Center

Locations

University Eye Clinic

Bochum, , Germany

University Eye Clinic

Heidelberg, , Germany

Ayrshire Eye Clinic and Laser Center

Ayr, Scotland, United Kingdom

Countries

Germany; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: CSP-025-05 rev DE protocol and SAP 05-16-2019_Redacted

View Document

Document Type: Study Protocol and Statistical Analysis Plan: CSP-025 rev 5 UK protocol and SAP 05-16-2019_Redacted

View Document

Other Identifiers

CSP-025-03

Identifier Type: -

Identifier Source: org_study_id