PURPOSE: To compare vision-related quality of life after binocular implantation of the Tecnis Z9000 intraocular lens (IOL) (Advanced Medical Optics) or the AcrySof MA60AC IOL (Alcon). SETTING: Moorfields Eye Hospital, London, United Kingdom. METHODS: The study was a double-masked prospective randomized controlled trial. The main outcome measure was the percentage of patients achieving a Visual Function-14 (VF-14) score of 90 or higher. Additional outcome measures were dysphotopsia symptom scores, a 5-point subjective grading of overall satisfaction, refraction, photopic and mesopic best corrected visual acuities, uncorrected visual acuity, Pelli-Robson contrast sensitivity, aberrometry, infrared pupillometry, and evaluation of posterior capsule opacification scores. RESULTS:Seventy-nine patients who had bilateral implantation of the Z9000 IOL and 100 patients who had bilateral implantation of the MA60AC IOL were assessed a mean of 7.9 months +/- 2.9 (SD) (range 4 to 16 months) after second-eye surgery. Spherical aberration (mean: Z9000, 0.00 microm +/- 0.06 [SD]; MA60AC, +0.14 +/- 0.09 microm) and root mean square scores for higher-order aberrations combined (mean: Z9000, 0.26 +/- 0.11 microm; MA60AC, 0.32 +/- 0.14 microm) were significantly lower in patients with the Z9000 IOL (P<.001 and P = .007, respectively). The VF-14 scores were 90 or higher in 96.2% of Z9000 patients and 90.0% of MA60AC patients (P = .15). It is unlikely that this weak trend in favor of the Z9000 IOL was clinically significant. The VF-14 scores were heavily skewed toward a perfect outcome and similarly distributed in both groups (median 100; interquartile range 98 to 100). Results for all other outcomes, including measures of acuity, were similarly distributed in Z9000 patients and MA60AC patients. CONCLUSIONS: The Z9000 IOL reduced spherical aberration compared with the MA60AC IOL. No improvement in subjective visual function using the VF-14 questionnaire was detected.
RCT Entities:
PURPOSE: To compare vision-related quality of life after binocular implantation of the Tecnis Z9000 intraocular lens (IOL) (Advanced Medical Optics) or the AcrySof MA60AC IOL (Alcon). SETTING: Moorfields Eye Hospital, London, United Kingdom. METHODS: The study was a double-masked prospective randomized controlled trial. The main outcome measure was the percentage of patients achieving a Visual Function-14 (VF-14) score of 90 or higher. Additional outcome measures were dysphotopsia symptom scores, a 5-point subjective grading of overall satisfaction, refraction, photopic and mesopic best corrected visual acuities, uncorrected visual acuity, Pelli-Robson contrast sensitivity, aberrometry, infrared pupillometry, and evaluation of posterior capsule opacification scores. RESULTS: Seventy-nine patients who had bilateral implantation of the Z9000 IOL and 100 patients who had bilateral implantation of the MA60AC IOL were assessed a mean of 7.9 months +/- 2.9 (SD) (range 4 to 16 months) after second-eye surgery. Spherical aberration (mean: Z9000, 0.00 microm +/- 0.06 [SD]; MA60AC, +0.14 +/- 0.09 microm) and root mean square scores for higher-order aberrations combined (mean: Z9000, 0.26 +/- 0.11 microm; MA60AC, 0.32 +/- 0.14 microm) were significantly lower in patients with the Z9000 IOL (P<.001 and P = .007, respectively). The VF-14 scores were 90 or higher in 96.2% of Z9000 patients and 90.0% of MA60ACpatients (P = .15). It is unlikely that this weak trend in favor of the Z9000 IOL was clinically significant. The VF-14 scores were heavily skewed toward a perfect outcome and similarly distributed in both groups (median 100; interquartile range 98 to 100). Results for all other outcomes, including measures of acuity, were similarly distributed in Z9000 patients and MA60ACpatients. CONCLUSIONS: The Z9000 IOL reduced spherical aberration compared with the MA60AC IOL. No improvement in subjective visual function using the VF-14 questionnaire was detected.