Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes

RxSight

Status

Completed

Conditions

Cataract

Aphakia

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT04529616

CSP-036

Details and patient eligibility

About

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.

Enrollment

79 patients

Sex

All

Ages

30+ 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.
Age 30 or older on the day the cataract surgery is performed.
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 diabetes with any evidence of retinopathy.
Study eye with history of uveitis.
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.
Study eye with history of ocular herpes simplex virus.