Light Adjustable Lens Study
This is a randomized, controlled clinical study investigating the safety and effectiveness of the RxSight® Light Adjustable Lens™ in subjects undergoing bilateral cataract surgery and IOL implantation who desire an extended depth of focus.
The Light Adjustable Lens is the first and only FDA-approved IOL that can be adjusted postoperatively to improve uncorrected visual acuity. First, routine cataract surgery is performed, the Light Adjustable Lens is implanted, and then approximately 2-3 weeks after surgery, the Light Delivery Device (LDD) is used to adjust the lens based on the manifest refraction. For this trial, RxSight (the manufacturer of the LAL) has developed a light treatment pattern that is designed to extend depth of focus and improve intermediate and near vision in patients looking to address post-operative presbyopia. We are excited to be part of this clinical trial that may lead to FDA approval for this indication.
Study subjects who meet all inclusion/exclusion criteria will be randomized 1:1 to either undergo bilateral Light Adjustable Lens implantation and light treatments for refractive and presbyopia correction (LAL group) or to undergo bilateral implantation with commercially available IOLs (Tecnis ZCB00 monofocal IOL or Tecnis Toric IOL, Johnson & Johnson Vision) (Control group).
The following is a brief summary of the study inclusion/exclusion criteria:
- Age 40 to 80
- BCDVA of 20/40 or worse in both eyes
- Preoperative keratometric cylinder < 0.75 D in one or both eyes
- Average dilated pupil diameter of ≥ 7.0 mm in both eyes
- No significant ocular morbidity (including preexisting macular disease) or previous intraocular surgery in either eye
- No current use of photosensitizing systemic medications such as doxycycline, chloroquine, amiodarone, and hydrochlorothiazide
If you would like to see whether you are a candidate for this trial, please contact our study coordinator Beverly Socop at 713-626-5544 or firstname.lastname@example.org. There is no fee to participate in the trial, and patients will receive compensation for participating in the study.
This study has completed enrollment.
We have teamed up with RxSight to participate in a clinical trial for a revolutionary cataract lens. We are currently recruiting patients who have had previous refractive surgery (LASIK, LASEK) and are in need of cataract surgery. The revolutionary lens allows us to use a Light Delivery Device (LDD) to adjust any leftover prescription following your cataract surgery. You will be required to attend timely post-operative visits and may be compensated up to $600. Please understand this is a 2-step process and you’re not guaranteed to qualify until you have met both steps. If you think you may qualify, please call 713 626 5544 to schedule your cataract evaluation.
Please click here for more info on RxSight.
Data Compilation to Determine the Reliability of an Automated Refraction Device
This study has completed enrollment.
If you have been diagnosed with cataracts in both eyes, you may qualify for a clinical study that is investigating wavefront measurement technology during cataract surgery.
This research study involves evaluating wavefront measurements captured during cataract surgery against traditional cataract surgery methods.
This study might be a good fit for you if:
- Are 22 years of age or older;
- Have been diagnosed with cataracts in both eyes;
- Are qualified to have toric lenses implanted in both eyes;
- Have not had any previous eye surgeries;
- Be willing to comply with the follow-up visits
A formal consent process and ocular screening are required before decisions can be made about your enrollment and willingness to be involved with this study.