The SBL-3 ClearView clinical study, an FDA investigational device exemption clinical trial conducted at 18 sites across the US, is a prospective, subject-masked, randomized, two-arm study.
Reviewed by Y. Ralph Chu, MD
The Lenstec SBL-3 multifocal intraocular lens (IOL) achieved best-corrected distance visual acuity (BCDVA) and uncorrected distance VA (UCDVA) levels that were comparable to those achieved with a control IOL and achieved substantially better uncorrected near VA (UCNVA) and distance-corrected near VA (DCNVA), according to Y. Ralph Chu, an ophthalmologist in private practice in Bloomington, Minnesota.
SBL-3 clinical study
The SBL-3 ClearView clinical study, an FDA investigational device exemption
clinical trial conducted at 18 sites across the US, is a prospective, subject-masked, randomized, two-arm study. The participants included 340 subjects in which the SBL-3 IOL was implanted in both eyes and 170 subjects in which a control IOL was implanted in both eyes. The patients were followed at regular intervals: 1 day, 1 to 2 weeks, 1 to 2 months, 4 to 6 months, and 1 year following implantation.
Refractive results at all distances at 1 year
Chu reported the binocular data collected from the 18 clinical sites. A total of 313 patients who received the SBL-3 and 161 patients who received the control IOL completed the 1-year examination.
At the 1-year time point, the binocular UCDVA showed that 57.8% and 71.4% of the SBL-3 implanted patients and the control patients achieved 20/20 vision or better, and the respective BCDVA levels were 83.8% and 95.1%, achieving 20/20 vision or better.
The respective percentages of UCNVA were 40.3% and 0.0%, and for the DCNVA, 33.9% and 0.0%.
The respective percentages of uncorrected intermediate VA (UCIVA) levels were 48.9% and 7.5%, and those of the distance-corrected near VA (DCIVA) were 43.8% and 5.0%.
Using a scale of 1 to 5 at the 1-year examination, fewer patients with the SBL-3 IOL implant reported needing vision correction at all distances compared with the controls, ie, 1.26 vs 1.59 for distance vision, 1.27 vs 3.01 for intermediate vision, and 1.33 vs 3.74 for near vision. On the scale, 1 indicated never; 2, some of the time; 3, about half the time; 4, most of the time; and 5, all of the time.
The lens under study performed well at all distances. The UCDVA and BCDVA were comparable to the VA achieved with the control IOL. The UCNVA and DCNVA were significantly better than the levels achieved with the control IOL, and the SBL-3 provided considerably better UCIVA and DCIVA compared with the control. In addition, the SBL-3 defocus curve showed excellent functional vision at all distances, Chu said.
“From our early clinical experience, patients are subjectively very satisfied with their range and quality of vision,” Chu said. “There have been no increased reports of dysphotopsias compared to other available multifocal presbyopia-correcting IOLs.”
Y. Ralph Chu, MD
Chu is founder and CEO of Chu Vision Institute in Bloomington, Minnesota, and is a consultant to numerous manufacturers of IOLs. He is a paid investigator for the SBL-3 clinical study.