40 and older, any sex, with Pseudophakia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
0.03
± 0.04
Distance With Enhanced Intermediate/Near Visual Acuity Group
0.01
± 0.02
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.Primary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
0.30
± 0.07
Distance With Enhanced Intermediate/Near Visual Acuity Group
0.12
± 0.07
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.Secondary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
4.16
± 0.77
Distance With Enhanced Intermediate/Near Visual Acuity Group
3.64
± 0.77
Spherical Aberration Between GroupsSecondary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
0.29
± 0.16
Distance With Enhanced Intermediate/Near Visual Acuity Group
0.31
± 0.15
Q Value Between Groups.Secondary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
-0.34
± 0.23
Distance With Enhanced Intermediate/Near Visual Acuity Group
-0.31
± 0.18
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.Secondary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
Anterior Chamber Depth
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
3.25
± 0.32
Distance With Enhanced Intermediate/Near Visual Acuity Group
3.19
± 0.41
Axial Length
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
24.33
± 1.36
Distance With Enhanced Intermediate/Near Visual Acuity Group
24.34
± 1.52
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.Secondary· 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
Never experiencing glare, halos, or starbursts.
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
45
Distance With Enhanced Intermediate/Near Visual Acuity Group
66
Never using glasses for distance vision
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
69
Distance With Enhanced Intermediate/Near Visual Acuity Group
84
Never using glasses for intermediate vision
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
55
Distance With Enhanced Intermediate/Near Visual Acuity Group
59
Never using glasses for near vision
Group
Value
95% CI
Distance With Minimal Intermediate Visual Acuity Group
24
Distance With Enhanced Intermediate/Near Visual Acuity Group
30
Sponsor's own 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 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT06963138 — Comparative Study and Validation of New Methodologies for Measuring Addition
· NA
· completed
NCT06064916 — Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
· completed
NCT06041139 — Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
· completed
NCT05226884 — Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
· completed
NCT04420962 — Automated Quantitative Ulcer Analysis Study
· completed
Other recruiting trials for Pseudophakia
Currently open trials in the same condition.
NCT04692012 — Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
· NA
· active not recruiting
Other Berkeley Eye Center trials
Trials by the same sponsor.
NCT07475832 — Comparison of Two Biometers in Dense Cataracts
· completed
NCT06064916 — Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients
· completed
NCT06045325 — Assessment of Measurement Variability Across Automated Biometry Devices
· completed
NCT06041139 — Visual Outcomes and Patient Satisfaction With Bilateral PanOptix Verses Bilateral Synergy
· completed
NCT05226884 — Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Berkeley Eye Center
Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05611073.