Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:40 - 80
Updated:12/26/2018
Start Date:August 28, 2018
End Date:September 1, 2019
Contact:David Goffredo
Email:dgoffredo@rxsight.com
Phone:949-421-5463

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A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery

The primary objective of this study is to evaluate, for the visual correction of aphakia, the
safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery Device
(LDD) to reduce postoperative refractive error and improve uncorrected distance visual acuity
in eyes with prior corneal refractive surgery. A control group consisting of fellow eyes
implanted with a commercially available monofocal IOL will be used to compare the safety and
effectiveness of the LAL.


Inclusion Criteria:

- Must sign a written Informed Consent form and be willing to undergo cataract surgery
for the bilateral implantation of an intraocular lens (IOL).

- Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.

- History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive Keratectomy
(PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-LASIK, or Epi-LASEK
more than 1 year prior in both eyes.

- Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level
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:

- Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange (RLE),
or Corneal Inlay in either eye.

- Pre-existing macular disease in either eye.

- Patients with sufficiently dense cataracts that preclude examination of the macula in
either eye.

- History of uveitis in either eye.

- Evidence of ectasia in either eye.

- Previous intraocular surgery in either eye. 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.
We found this trial at
6
sites
Salt Lake City, Utah 84107
Principal Investigator: Robert J Cionni, MD
Phone: 801-266-2283
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Brecksville, Ohio 44141
Principal Investigator: William F Wiley, MD
Phone: 216-503-6535
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Brecksville, OH
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3900 Essex Lane
Houston, Texas 77027
Principal Investigator: Steven Slade, MD, FACS
Phone: 713-626-5544
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Houston, TX
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Leawood, Kansas 66211
Principal Investigator: John F Doane, MD
Phone: 816-350-6903
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Leawood, KS
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San Antonio, Texas 78229
Principal Investigator: James D Lehmann, MD
Phone: 210-614-3600
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San Antonio, TX
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Sioux Falls, South Dakota 57108
Principal Investigator: Vance Thompson, MD, FACS
Phone: 605-361-3937
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Sioux Falls, SD
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