Maximizing Visual Outcomes With Eyhance IOLs

NCT05611073 | Completed Results FDA Device

• 1 other identifier: JMM-1261
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudophakia

Keywords

Eyhance; Pseudophakia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

• Spherical Aberration Between Groups

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

• Q Value Between Groups.

  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.

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

Other Outcomes (1)

• 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.

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

Study Arms (2)

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; Diagnostic Test: Biometric Data Collection; Other: Patient Questionnaire

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; Diagnostic Test: Biometric Data Collection; Other: Patient Questionnaire

Interventions

Visual Acuity DIAGNOSTIC_TEST

Measurement of distance, intermediate and near visual acuity.

Distance with Enhanced Intermediate/Near Visual Acuity Group; Distance with Minimal Intermediate Visual Acuity Group

Biometric Data Collection DIAGNOSTIC_TEST

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

Distance with Enhanced Intermediate/Near Visual Acuity Group; Distance with Minimal Intermediate Visual Acuity Group

Patient Questionnaire 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; Distance with Minimal Intermediate Visual Acuity Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Berkeley Eye Center: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pseudophakia

Interventions

Visual Acuity; Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Tetiana Huff
• Organization: Berkeley Eye Center

tetiana.huff@berkeleyeye.com

713-620-7640

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: November 9, 2022
• Study Start: March 7, 2022
• Primary Completion: November 7, 2022
• Study Completion: November 7, 2022
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)