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

Cataract Clinical Trial

Official title:

A Prospective Multi-Center Clinical Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RxLAL) With the Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771352
• Other study ID #: CSP-025-03
• Status: Completed
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: July 1, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• RxSight RxLAL
The patients will be assessed for 6 months

Locations

Country	Name	City	State
Germany	University Eye Clinic	Bochum
Germany	University Eye Clinic	Heidelberg
United Kingdom	Ayrshire Eye Clinic and Laser Center	Ayr	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
RxSight, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety: ISO 11979-7 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 6 months
Other	Number of Eyes That Received Secondary Surgical Interventions (SSIs)	Secondary Surgical Interventions (SSIs) of the study eyes that occur during the conduct of the study.	Through study completion, an average of 6 months
Primary	Uncorrected Distance Visual Acuity (UCDVA) of 20/20 or Better	Percent of eyes with monocular uncorrected distance visual acuity of 20/20 or better	at 6 months postop