A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus

RxSight

Status

Terminated

Conditions

Cataract

Presbyopia

Aphakia

Treatments

Device: Light Adjustable lens (LAL) and Light Delivery Device (LDD) - Pre-COVID Population

Device: Tecnis ZCB00 or ZTC150 IOL

Device: SofPort LI61AO IOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT04177771

CSP-033

Details and patient eligibility

About

The primary objective of this study is to evaluate, for the visual correction of aphakia and presbyopia, the safety and effectiveness of the RxSight Light Adjustable Lens (LAL) to provide an extended depth of focus (improve intermediate and near visual acuity without compromising distance visual acuity) in subjects who have undergone bilateral implantation with the LAL and subsequent light treatments for refractive and presbyopia correction (LAL group).

Enrollment

34 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 the bilateral implantation of either the LAL or SofPort LI61AO intraocular lens (IOL) (Bausch + Lomb).
Must be willing to be randomized to either the LAL group (bilaterally implanted with the LAL and receive light treatments for refractive and presbyopia correction) or the Control group
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
Cataractous lens changes as demonstrated by best corrected distance visual acuity (BCDVA) of 20/40 or worse with or without a glare source in both eyes.
Willing and able to comply with the requirements for study specific procedures and visits.
Able to complete a written questionnaire in English.

Exclusion criteria

Pre-existing macular disease in either eye.
Patient with sufficiently dense cataract that precludes examination of the macula in either eye.
Diabetes with any evidence of retinopathy in either eye.
Evidence of glaucomatous optic neuropathy in either eye.
History of uveitis in either eye.
Keratoconus or suspected of having keratoconus in either eye.
Has undergone previous corneal or intraocular surgery in either eye, 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.
Subjects taking systemic medication that may increase sensitivity to UV light such as tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and methoxsalen. LDD treatment in patients taking such medications may lead to irreversible phototoxic damage to the eye. This is only a partial list of photosensitizing medications. Please evaluate all medications that the patient is taking for this effect prior to consideration for implantation.
Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
History of ocular herpes simplex virus in either eye.
Subject who has participated within another ophthalmic clinical trial within the last 3 months.