N/A
N=310
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Pseudophakia
Bottom Line
View on ClinicalTrials.gov: NCT05226884 ↗Enrolled (actual)
310
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset — 0.20; 0.19 LogMAR — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Visual Acuity (Diagnostic_test); Defocus Curve (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Berkeley Eye Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset |
0.20; 0.19 | <0.05 sig |
| PRIMARY Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity |
0.24; 0.19 | <0.05 sig |
| PRIMARY Non-inferiority of Best Corrected Distance Visual Acuity |
0.01; 0.02 | <0.05 sig |
| PRIMARY Binocular Distance Corrected Defocus Curve |
0.75; 0.74; 0.6; 0.58; 0.46; 0.44 | — |
| PRIMARY Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset |
0.03; 0.02 | <0.05 sig |
| SECONDARY Post-operative Spherical Equivalent |
-0.04; -0.04 | — |
| SECONDARY Postoperative Residual Astigmatism |
0.43; 0.36 | — |
Summary
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
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 Clareon intraocular lenses or Eyhance intraocular lenses (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 yttrium aluminum garnet laser 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 in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc)
- 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) in either eye.
- 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 (NCT05226884). 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.