C-09-035 - Clinical Investigation of AcrySof(RegisteredTM) IQ ReSTOR(RegisteredTM) Multifocal Toric IOL Model SND1T2
This is a device (Class III - Intra Ocular Lens), prospective, parallel-group, subject and observer-masked (manifest refraction and visual acuity), randomized, multi-site study. Both eyes of a subject must have pre-operative astigmatism (shape of the eye and/or cornea) between 0.50D ? 1.02D to qualify for enrollment into the study. Subject randomization will be grouped by astigmatism range into three groups: 1) 0.50D ? 0.59D, 2) 0.60D ? 0.74D, 3) 0.75 ? 1.02D determined by pre-operative corneal astigmatism in the first operative eye (first eye is defined as the eye with the lower astigmatism). Once maximum enrollment is achieved in the lower astigmatism stratum (0.50D ? 0.74D), for any new subjects with one eye in the lower astigmatism range (0.50D ? 0.74D) and the other in the higher range (0.75D ? 1.02D), the eye with the higher astigmatism will be allowed as first operative eye, in order to complete enrollment in the higher stratum.
At all times in the study, if a subject has 2 eyes that fall in the same stratum, the eye with the lower astigmatism should be implanted first.
Treatment Arms -
a. AcrySof IQ ReSTOR Multifocal Model SND1T2 ? Astigmatic range from 0.50D to 1.02D
b. AcrySof IQ ReSTOR Multifocal SN6AD1
Duration of Study
a. Total expected duration of the clinical investigation ? 18 months
b. Expected duration of each subject?s participation ? 13 months
c. Planned f/u duration ? 12 months
d. Recruitment effort ? 5 months
1. 21 years and older with planned cataract removal by Phacoemulsification in both eyes
2. Comprehend and sign IC
3. Calculated lens power within the available range
4. Willing and able to complete all required postoperative visits
5. Potential postoperative VA of 0.2logMAR or better in both eyes
6. Pre-operative astigmatism of 0.50D to 1.02D of predicted crossed cylinder in both eyes as calculated with the study toric IOL calculator.
7. Clear intraocular media other than cataract in study eyes
8. Preoperative BCDVA worse than 0.2 logMAR in each eye
9. Pupil size greater than 6mm after dilation
10. Subjects must be able to undergo second eye surgery within 30 days of the first eye surgery