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

RxSight

Status

Completed

Conditions

Cataract

Aphakia

Treatments

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03729024

CSP-028

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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