Exploratory 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

Cataract Clinical Trial

Official title:

A Single Center Exploratory 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: NCT03729024
• Other study ID #: CSP-028
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: February 4, 2020

Study information

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

Clinical Trial Summary

The objective of this study is to evaluate uncorrected distance vision and quality of vision as measured by the McAlinden QoV questionnaire 3 months following the final lock-in treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory study. No primary effectiveness endpoints will be defined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 4, 2020
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.

• Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.

• Study eye must have preoperative keratometric cylinder of =0.50 D and =3.00 D.

• Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.

• Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

• Study eye with zonular laxity or dehiscence.

• Study eye with pseudoexfoliation.

• Study eye with age-related macular degeneration involving the presence of geographic atrophy or soft drusen.

• Study eye with diabetes with any evidence of retinopathy.

• Study eye with evidence of glaucomatous optic neuropathy.

• Study eye with history of uveitis.

• Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless 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.

• Study eye with history of ocular herpes simplex virus.

• Study eye with history of a congenital color vision defect

Related Conditions & MeSH terms

• Aphakia
• Astigmatism
• Cataract

Intervention

Device:
• Light Adjustable lens (LAL) and Light Delivery Device (LDD)
Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments

Locations

Country	Name	City	State
Mexico	CODET Vision Institute	Tijuana

Sponsors (1)

Lead Sponsor	Collaborator
RxSight, Inc.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Eyes With UCDVA of 20/20 or Better		6 months