Visual and Patient-Reported Outcomes of a Novel Full Visual Range Intraocular Lens Versus a Monofocal Intraocular
Mitchell C Shultz1, William F Wiley2, Eva Liang3
1From Shultz Chang Vision (M.C.S.), Northridge, California, USA.
American Journal of Ophthalmology
|August 31, 2025
Summary
A new full visual range (FVR) intraocular lens (IOL) offers superior intermediate and near vision after cataract surgery compared to a standard monofocal IOL. Patients achieved excellent distance, intermediate, and near visual acuity with the FVR IOL.
Area of Science:
- Ophthalmology
- Biomedical Engineering
- Optics
Background:
- Cataract surgery involves replacing the clouded natural lens with an artificial intraocular lens (IOL).
- Current IOL technology aims to restore clear vision at various distances, with monofocal and multifocal designs being common.
- Advancements in IOLs seek to provide a continuous range of vision, minimizing the need for corrective eyewear.
Purpose of the Study:
- To compare visual, refractive, and patient-reported outcomes of a novel full visual range (FVR) IOL against a standard monofocal IOL.
- To evaluate the efficacy of the FVR IOL in subjects undergoing bilateral cataract surgery.
Main Methods:
- A prospective, masked, multicenter, controlled pivotal trial was conducted.
- Subjects were randomized to receive either the novel FVR IOL (N=332) or a standard monofocal IOL (N=169) bilaterally.
- Primary endpoints included monocular corrected distance, intermediate, and near visual acuity; secondary endpoints included binocular uncorrected and distance-corrected visual acuities at 120-180 days post-surgery.
Main Results:
- The FVR IOL was non-inferior for distance visual acuity and statistically superior for intermediate and near visual acuity compared to the monofocal IOL.
- Binocular uncorrected and distance-corrected intermediate and near visual acuities were significantly better with the FVR IOL (p<0.0001).
- Mean postoperative refractive error was similar between groups; FVR IOL provided consistent visual acuity across a range of distances.
Conclusions:
- The FVR IOL demonstrated superior intermediate and near visual acuity with comparable distance visual acuity versus the monofocal IOL.
- Bilateral FVR IOL implantation resulted in excellent uncorrected visual acuity from distance to near (0.09 logMAR or better).
- The novel FVR IOL offers a promising option for cataract patients seeking a broad range of clear vision.
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