Maximizing Visual Outcomes With Eyhance IOLs

Study Overview
=================
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.

Official Title
-----------------
Maximizing Visual Outcomes With Eyhance IOLs

Conditions
-----------------
Pseudophakia

Intervention / Treatment
-----------------
* Diagnostic Test: Visual Acuity
* Diagnostic Test: Biometric Data Collection
* Other: Patient Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
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.).

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Distance with Minimal Intermediate Visual Acuity Group<br>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. | Diagnostic Test: Visual Acuity<br>* Measurement of distance, intermediate and near visual acuity.<br>Diagnostic Test: Biometric Data Collection<br>* Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.<br>Other: Patient Questionnaire<br>* Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.<br>|
| Distance with Enhanced Intermediate/Near Visual Acuity Group<br>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. | Diagnostic Test: Visual Acuity<br>* Measurement of distance, intermediate and near visual acuity.<br>Diagnostic Test: Biometric Data Collection<br>* Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.<br>Other: Patient Questionnaire<br>* Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of two groups categorized by 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. | To compare two groups categorized by distance with minimal intermediate and distance with enhanced intermediate/near based on mean photopic binocular BCDVA and DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere. | minimum of 3 weeks post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | minimum of 3 weeks post operatively | 
| Determine if any statistically significant differences in spherical aberration exists between the two groups. | To determine if any statistically significant differences in spherical aberration 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. | minimum of 3 weeks post operatively | 
| Determine if any statistically significant differences in q value exists between the two groups. | To determine if any statistically significant differences in q value 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. | minimum of 3 weeks post operatively | 
| Determine if any statistically significant differences in biometric data exists between the two 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. | minimum of 3 weeks post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eyhance, Pseudophakia