Clinical trial NCT04177771: A Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
Official title: A Prospective Randomized Controlled Multi-center Clinical Study to Evaluate The Safety and Effectiveness of The RxSight Light Adjustable Lens (LAL) In Subjects Desiring an Extended Depth of Focus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Aphakia
Cataract
Presbyopia
Keywords: Light Adjustable Lens
Intraocular lens
LAL
Lead sponsor: RxSight, Inc.
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 34
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 to undergo experimental or control treatment.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Monocular Depth of Focus (DOF) Measured at the logMAR 0.2 Level Compared Between LAL Treatment Group and Control Group
timeFrame: Postop Month 6
measure: Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 67 cm Compared Between LAL Treatment Group and Control Group
timeFrame: Postop Month 6
measure: Outcome of Monocular Photopic DCIVA at 67 cm Better Than or Equal to 0.20 logMAR for the LAL Group at Postop Month 6
timeFrame: 6 months
measure: Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) Compared Between LAL Treatment Group and Control Group
timeFrame: Postop Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
Study officials:
References: