- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05226884
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
This is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU***) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to determine binocular intermediate vision.
Patients will be assessed for corrected binocular distance and intermediate vision.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, two-arm comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. 155 subjects will be enrolled in each arm of the study, with 310 total subjects. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU***) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to determine binocular intermediate vision.
Patients will be assessed for corrected binocular distance and intermediate vision at plano for the Eyhance group and -0.25D for Clareon group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77027
- Berkeley Eye Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clareon IOL Group
Patients with bilateral implantation of Clareon IOLs.
|
Measurement of distance and intermediate visual acuity at variety targeted correction.
Measurement of a defocus curve
|
Eyhance IOL Group
Patients with bilateral implantation of EyhanceIOLs.
|
Measurement of distance and intermediate visual acuity at variety targeted correction.
Measurement of a defocus curve
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distance target-corrected binocular intermediate (66 cm) visual acuity
Time Frame: minimum of 3 weeks post operatively
|
Distance target-corrected binocular intermediate (66 cm) visual acuity of Clareon subjects at -0.25 sphere and the Eyhance subjects plano sphere.
|
minimum of 3 weeks post operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Binocular target corrected defocus curve
Time Frame: minimum of 3 weeks post operatively
|
Binocular target corrected defocus curve
|
minimum of 3 weeks post operatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69901155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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