PURPOSE: To compare the ocular wave-front of eyes with silicone Intraocular lens (IOLs) with aspheric and spherical optics after cataract surgery, taking into account the patient's pupil size under reading conditions and after pupil dilatation. METHODS: In this institutional prospective, randomized, controlled, patient and examiner masked, bilateral trial with intra-individual comparison, 60 eyes of 30 patients with bilateral age-related cataract were included. Each patient received a spherical IOL (CeeOn Edge, 911A, AMO, Santa Ana, CA, USA) in one eye and an aspheric IOL (Tecnis, Z9000, AMO) in the contra-lateral eye. Exclusion criteria were other ocular pathologies, capsular changes or zonular weakness. The main outcome variable was spherical aberration of the ocular wave-front under mesopic pupil conditions measured 2 years after surgery. Additional outcome variables were visual acuity and photopic and mesopic contrast sensitivity. RESULTS: There was no significant difference in visual acuity between the two IOL types under physiological pupil conditions and also not after pupil dilation. However, spherical aberrations were significantly lower with the aspheric IOL (SA: spherical 0.38 μm, SD: 0.11 μm; aspheric 0.10 μm, SD: 0.13 μm; p < 0.01), and there was a significant difference in contrast sensitivity at 12 cycles/degree. CONCLUSIONS: This is the first randomized and masked trial on visual function and ocular wave-front after implantation with this silicone aspheric IOL, taking the patients' own pupil size into account. The effect on visual function was detectable for mesopic contrast sensitivity, but there was no difference in visual acuity. The SA was found to be significantly lower under physiological pupil conditions as well as when recalculated for the rhexis size and under pharmacological dilatation.
RCT Entities:
PURPOSE: To compare the ocular wave-front of eyes with silicone Intraocular lens (IOLs) with aspheric and spherical optics after cataract surgery, taking into account the patient's pupil size under reading conditions and after pupil dilatation. METHODS: In this institutional prospective, randomized, controlled, patient and examiner masked, bilateral trial with intra-individual comparison, 60 eyes of 30 patients with bilateral age-related cataract were included. Each patient received a spherical IOL (CeeOn Edge, 911A, AMO, Santa Ana, CA, USA) in one eye and an aspheric IOL (Tecnis, Z9000, AMO) in the contra-lateral eye. Exclusion criteria were other ocular pathologies, capsular changes or zonular weakness. The main outcome variable was spherical aberration of the ocular wave-front under mesopic pupil conditions measured 2 years after surgery. Additional outcome variables were visual acuity and photopic and mesopic contrast sensitivity. RESULTS: There was no significant difference in visual acuity between the two IOL types under physiological pupil conditions and also not after pupil dilation. However, spherical aberrations were significantly lower with the aspheric IOL (SA: spherical 0.38 μm, SD: 0.11 μm; aspheric 0.10 μm, SD: 0.13 μm; p < 0.01), and there was a significant difference in contrast sensitivity at 12 cycles/degree. CONCLUSIONS: This is the first randomized and masked trial on visual function and ocular wave-front after implantation with this silicone aspheric IOL, taking the patients' own pupil size into account. The effect on visual function was detectable for mesopic contrast sensitivity, but there was no difference in visual acuity. The SA was found to be significantly lower under physiological pupil conditions as well as when recalculated for the rhexis size and under pharmacological dilatation.