N/A
N=110
Maximizing Visual Outcomes With Eyhance IOLs
Pseudophakia
Bottom Line
View on ClinicalTrials.gov: NCT05611073 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: 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. — 0.03; 0.01 logMAR
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Visual Acuity (Diagnostic_test); Biometric Data Collection (Diagnostic_test); Patient Questionnaire (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Berkeley Eye Center
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
0.03; 0.01 | — |
| PRIMARY 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. |
0.30; 0.12 | — |
| SECONDARY Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups. |
4.16; 3.64 | — |
| SECONDARY Spherical Aberration Between Groups |
0.29; 0.31 | — |
| SECONDARY Q Value Between Groups. |
-0.34; -0.31 | — |
| SECONDARY Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups. |
3.25; 3.19; 24.33; 24.34 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.).
Data sourced from ClinicalTrials.gov (NCT05611073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.