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A novel one-piece, bioanalogic extended-depth-of-focus (EDOF) IOL (Wichterle-Continuous Focus IOL [WIOL-CF], Medicem International CR) without haptics may be an option for patients desiring correction of presbyopia after cataract surgery, according to H. Burkhard Dick, MD, PhD, FEBOS-CR.
A multicenter clinical trial reported excellent visual outcomes and high patient satisfaction with bilateral implantation of this IOL after cataract surgery, according to H. Burkhard Dick, MD, PhD, FEBOS-CR.
This IOL boasts a number of characteristics, i.e., negative spherical aberrations providing its smooth hyperbolic curve, an infinite number of focal points that extend the depth of focus, refractive power that is maximal in the center that continuously decreases without steps to the periphery, and a large optic that ensures maximal light in the eye, noted Dr. Dick, professor of ophthalmology and chairman, Ruhr University Eye Hospital, Bochum, Germany.
The IOL powers range from +15 to +30 D in 0.5-D steps; the overall and optic diameters are 8.6 and 8.9 mm; the lens thicknesses range from 0.8 to 1.7 mm, the refractive index is 1.428 ± 0.003, and the water content is 42 ± 2%, Dr. Dick noted.
CLINICAL TRIAL
This 11-center, prospective, clinical trial-conducted in Belgium, the Czech Republic, Germany, Italy, and Spain-included 230 eyes of 115 patients (44 men, 71 women). The mean patient age was 65.0 ± 6.7 years (range, 50 to 75 years). The average IOL power was 25.0 ± 2.37 D (range, 17.0 to 30.0 D).
The investigators conducted the trial with the goal of evaluating the clinical outcomes of the WIOL-CF after bilateral implantation during femtosecond laser-assisted cataract surgery.
Patients were followed for 6 months postoperatively. The primary endpoint was the binocular uncorrected visual acuity.
The targeted treatment was 0.0 ± 0.25 D in the dominant eye and -0.50 ± 0.25 D in the non-dominant eye.Dr. Dick noted that the uncorrected distance visual acuity and the uncorrected intermediate visual acuity were excellent and the uncorrected near visual acuity was very good.
Investigators reported that implantation of the IOL after laser cataract surgery was safe and effective. Patients were highly satisfied with their levels of spectacle independence, he noted.
When patients were questioned about use of spectacle correction postoperatively, 95.6% reported they never or rarely used corrective glasses for distance vision during the day, 96.5% never or rarely did for distance vision during nighttime hours, and 75.4% never or rarely did for near vision during the day.
Patients also reported comparatively low levels of optical phenomena, i.e., 88.3% reported never or rarely experiencing halos and 87% reported never or rarely experiencing glare. The fact that there still were few photic phenomena at all is under investigation, Dr. Dick noted.
“This large trial confirmed the previous results of investigations with smaller numbers of patients,” he said.
“Bilateral implantation of the EDOF WIOL-CF provided excellent distance and intermediate vision and good near vision while maintaining excellent contrast sensitivity, high patient satisfaction, and high levels of spectacle independence,” Dr. Dick concluded. “The WIOL-CF is a novel, effective, and reliable surgical solution for the correction of presbyopia.”
H. BURKHARD DICK, MD, PHD, FEBOS-CR
E dickburkhard@aol.com
Dr. Dick is a consultant to Medicem and a member of the company’s Speakers’ Bureau.