Maximizing Visual Outcomes With Eyhance IOLs

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.

Study Overview

• Status: Completed
• Conditions: Pseudophakia
• Intervention / Treatment: Diagnostic test: Visual Acuity; Diagnostic test: Biometric Data Collection; Other: Patient Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Berkeley Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance IOLs.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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.
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc.).
3. History of or current retinal conditions or predisposition to retinal conditions.
4. Amblyopia or strabismus in either eye.
5. History of or current anterior or posterior segment inflammation of any etiology.
6. Any form of neovascularization on or within the eye.
7. Glaucoma (uncontrolled or controlled with medication).
8. Optic nerve atrophy.
9. Subjects with diagnosed degenerative eye disorders.
10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen).
11. 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.).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

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

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.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Spherical Aberration Between Groups		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	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.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of a Patient Satisfaction Survey Between the Two Groups to Assess for Subjective Differences in Everyday Life. Patient's Answers Will be on a Scale Between Always and Never, Where Never Shows a Better Patient Outcome.	Comparison of a patient satisfaction survey between the two groups to assess for subjective differences in everyday life to determine if the enhanced vision plays a statistically significant difference in patient's perceived quality of vision or quality of life. Patient's answers will be on a scale between always and never, where never shows a better patient outcome.	1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Investigators: Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): November 7, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Eyhance; Pseudophakia
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: JMM-1261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes