NCT05611073

Maximizing Visual Outcomes With Eyhance IOLs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Berkeley Eye Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-07
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2022-11-09
• Last updated: 2025-05-23
• Results posted: 2025-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study