Status:
COMPLETED
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
Lead Sponsor:
RxSight, Inc.
Conditions:
Aphakia
Cataract
Eligibility:
All Genders
30+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT04529616
Start Date
May 22 2020
End Date
October 1 2022
Last Update
February 10 2025
Active Locations (1)
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1
CODET Vision Institute
Tijuana, Mexico