RxSight Light Adjustable Lens and Light Delivery Device New Enrollment Study

• Light Adjustable lens (LAL) and Light Delivery Device (LDD) (Device): Experimental treatment group will receive Light adjustable lens with Light delivery Device treatments
• Control IOL (Device): Control treatment group will receive a Control IOL

Primary outcomes

• Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]
• Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control [Postop Month 6]

Secondary outcomes

• Rate of Endothelial Cell Density Loss [Postop Month 6]: The median difference was compared against a 5% non-inferiority margin for endothelial cell density loss using a right-tail Mann-Whitney-Wilcoxon test with a significance level of 0.05.
• Rate of Retinal Findings [Postop Month 6]: Rate of retinal findings in the Light adjustable lens (LAL) and Light Delivery Device (LDD) treatment group only.

Sex: All, ages: 40 Years to 80 Years

Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for the implantation of an IOL with random assignment to either the RxSight LAL or the monofocal control IOL.
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* 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.
* 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.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* History of ocular herpes simplex virus in either eye.

Participant flow

Outcome results

• Absolute Manifest Refraction Spherical Equivalent (MRSE) Compared Between the Two Study Groups, LAL and Control (Primary), Mean, Diopters: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 0.210 +/- 0.213; Control IOL 0.345 +/- 0.265
• Absolute Manifest Cylinder (MRCYL) Compared Between the Two Study Groups, LAL and Control (Primary), Mean, Diopters: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 0.262 +/- 0.275; Control IOL 0.820 +/- 0.554
• Rate of Endothelial Cell Density Loss (Secondary), Median, percentage Endothelial Cell Change: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 5.1 (3.8 to 7.0); Control IOL 4.9 (3.0 to 6.5) (p <0.0001)
• Rate of Retinal Findings (Secondary), Count of participants, Participants: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 0
• Odds and Odds Ratio of Achieving Uncorrected Distance Visual Acuity (UCDVA) 20/20 or Better at Postop Month 6 Compared Between the RxSight LAL and Control Group (Post hoc), Count of participants, Participants: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 274; Control IOL 83
• Odds and Odds Ratio of Achieving 0.5 Diopters or Less of Absolute MRCYL Compared Between the RxSight LAL and Control Group (Post hoc), Count of participants, Participants: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 307; Control IOL 61
• Odds and Odds Ratio of Achieving Simultaneous Absolute Manifest Refraction Spherical Equivalent (MRSE) and Absolute Manifest Cylinder (MRCYL) of 0.50 D or Less at Postop Month 6 Compared Between the RxSight LAL and Control Group (Post hoc), Count of participants, Participants: Light Adjustable Lens (LAL) and Light Delivery Device (LDD) 291; Control IOL 54

Adverse events

Time frame: 6 months

Serious adverse events by term

Other adverse events by term

• Results publication: Schallhorn JM, Rajanala A. Clinical outcomes of patients bilaterally implanted with the light adjustable lens: results of a phase IV clinical registry. J Cataract Refract Surg. 2026 Oct 1;52(10):1015-1022. doi: 10.1097/j.jcrs.0000000000001994. Epub 2026 Jun 16. PMID 42302210
• Results publication: Holladay JT, Haller M. Light-adjustable lens results of spherical equivalent and astigmatism correction from the U.S. Food and Drug Administration postapproval study. J Cataract Refract Surg. 2026 Jul 1;52(7):666-669. doi: 10.1097/j.jcrs.0000000000001906. PMID 41664266

• Study Protocol and Statistical Analysis Plan (PDF, 2023-01-20)