Maximizing Visual Outcomes With Eyhance IOLs

Berkeley Eye Center

Status: Completed

Conditions: Pseudophakia

Treatments: Other: Patient Questionnaire; Diagnostic Test: Biometric Data Collection; Diagnostic Test: Visual Acuity

Study type: Observational

Funder types: Other

Identifiers

NCT05611073

JMM-1261

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

110 participants in 2 patient groups

Distance with Minimal Intermediate Visual Acuity Group

Description:

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.

Treatment:

Diagnostic Test: Visual Acuity

Diagnostic Test: Biometric Data Collection

Other: Patient Questionnaire

Distance with Enhanced Intermediate/Near Visual Acuity Group

Description:

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.

Treatment:

Diagnostic Test: Visual Acuity

Diagnostic Test: Biometric Data Collection

Other: Patient Questionnaire