Maximizing Visual Outcomes With Eyhance IOLs

Completed

Interventions: Diagnostic Test: Visual Acuity
Diagnostic Test: Biometric Data Collection
Other: Patient Questionnaire

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes.
Implantation of bilateral Eyhance IOLs (DIB00/DIU***).
Able to comprehend and willing to sign informed consent and complete all required testing procedures.
Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better.
Clear intraocular media.
Minimum of two weeks post YAG capsulotomy to treat PCO

Exclusion Criteria

Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study.
Any complication during cataract surgery (capsular tear, vitrectomy, etc.).
History of or current retinal conditions or predisposition to retinal conditions.
Amblyopia or strabismus in either eye.
History of or current anterior or posterior segment inflammation of any etiology.
Any form of neovascularization on or within the eye.
Glaucoma (uncontrolled or controlled with medication).
Optic nerve atrophy.
Subjects with diagnosed degenerative eye disorders.
Postoperative CDVA worse than 0.10 logMAR (20/25 snellen).
Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc.).

Arm && Interventions

Group	Intervention	Description
Distance with Minimal Intermediate Visual Acuity Group	Visual Acuity	Patients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse.
Distance with Minimal Intermediate Visual Acuity Group	Biometric Data Collection	Patients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse.
Distance with Enhanced Intermediate/Near Visual Acuity Group	Visual Acuity	Patients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better.
Distance with Enhanced Intermediate/Near Visual Acuity Group	Biometric Data Collection	Patients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better.
Distance with Minimal Intermediate Visual Acuity Group	Patient Questionnaire	Patients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse.
Distance with Enhanced Intermediate/Near Visual Acuity Group	Patient Questionnaire	Patients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better.

Primary Outcome Measures

Name	Time	Method
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.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	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.
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.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	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.

Secondary Outcome Measures

Name	Time	Method
Q Value Between Groups.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	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
Spherical Aberration Between Groups	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.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	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.
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)	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.