This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction.
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be assessed in the 1-6-month post-operative period. Patients will be grouped into two arms: "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA and DCIVA (at 66 cm) of patients with bilateral Eyhance IOLs corrected to plano sphere. The "distance with minimal intermediate" group is defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. The "distance with enhanced intermediate/near" is defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. In addition to binocular BCDVA and DCIVA, monocular measurements will be obtained as well. The two groups will be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction. Biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Study Type
OBSERVATIONAL
Enrollment
110
Measurement of distance, intermediate and near visual acuity.
Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
Berkeley Eye Center
Houston, Texas, United States
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular DCIVA (at 66 cm) of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.
To determine if any statistically significant differences in pupil size exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Spherical Aberration Between Groups
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Q Value Between Groups.
Q-value is an assessment of corneal asphericity. * A value of 0 indicates a cornea that is perfectly spherical * A value between -1 and 0 indicates a cornea that is shaped more like a football * A value between 0 and 1 indicates a cornea that is shaped more like a dish
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Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
To determine if any statistically significant differences in biometric data exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)