Maximizing Visual Outcomes With Eyhance IOLs

NCT ID: NCT05611073

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-11-07

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.

Conditions

Pseudophakia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Visual Acuity

Intervention Type: DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Biometric Data Collection

Intervention Type: DIAGNOSTIC_TEST

Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.

Patient Questionnaire

Intervention Type: OTHER

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.

Visual Acuity

Intervention Type: DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Biometric Data Collection

Intervention Type: DIAGNOSTIC_TEST

Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.

Patient Questionnaire

Intervention Type: OTHER

Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.

Interventions

Visual Acuity

Measurement of distance, intermediate and near visual acuity.

Intervention Type: DIAGNOSTIC_TEST

Biometric Data Collection

Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.

Intervention Type: DIAGNOSTIC_TEST

Patient Questionnaire

Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.

Intervention Type: OTHER

Eligibility Criteria

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.).

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Berkeley Eye Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morgan Micheletti, MD

Role: PRINCIPAL_INVESTIGATOR

Berkeley Eye Center

Locations

Berkeley Eye Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JMM-1261

Identifier Type: -

Identifier Source: org_study_id