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First Author: J.Pepose USA
Co Author(s): R. Chu M. Qazi
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To compare the results of quality of vision surveys following prospective, randomized, masked bilateral implantation of Crystalens AO, ReSTOR + 3, or Tecnis Multifocal IOLs.
Private ophthalmology practice.
This was a prospective, randomized, patient masked, post-market study of 3 presbyopia- correcting IOLs: Crystalens AO (n=26), ReSTOR +3 (n=25), and Tecnis Multifocal (n=22). One, three, and six months following bilateral, sequential implantation of a single, randomly-selection IOL type, the National Eye Institute Refractive Error Quality of Life Instrument (NEI-RQL-42) and the Subjective Visual Index Questionnaire were administered. The NEI-RQL-42 was scored and statistically compared for 13 question subgroups.
All three lenses had similar aggregate NEI-RQL scores and clarity of vision scores. NEI-RQL results for the 3 IOL types showed ReSTOR better than Tecnis MF for far vision subcategory (p=-.016) and Tecnis MF better than Crystalens for the near (p=0.036). The Crystalens AO group had fewer (15.3%) patients who reported moderate to high difficulty with intermediate compared to ReSTOR +3 (28.0%) and Tecnis MF (27.3.%).The Crystalens AO had the best scores in the glare subgroup of questions (p<0.01 compared to Tecnis MF), with both Tecnis MF and ReSTOR 3.0 mean subjective halo scores >2x that of Crystalens AO. Both multifocals showed statistically less dependence on glasses vs Crystalens (p=0.004).
All three FDA approved presbyopia-correcting IOLs showed excellent satisfaction scores. Assessment of subjective visual experiences and photic phenomena corroborated visual acuity and optical scatter outcomes, showing Crystalens associated with less visual disturbances. The Crystalens had lower intermediate vision complaints, while the Tecnis MF had subjectively better near, and both multifocal had less dependence on glasses. This study allows comparison of 3 FDA-approved presbyopia-correcting IOLs to previous QOL studies while helping physicians to match each IOLs inherent strengths and weaknesses to each patients individual needs.
... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... receives consulting fees, retainer, or contract payments from a competing company