Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
NCT ID: NCT05226884
Last Updated: 2024-11-15
Study Results
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View full resultsBasic Information
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COMPLETED
310 participants
OBSERVATIONAL
2021-11-30
2022-08-06
Brief Summary
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Detailed Description
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Patients will be assessed for corrected binocular distance and intermediate vision.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Clareon IOL Group
Patients with bilateral implantation of Clareon IOLs.
Visual Acuity
Measurement of distance and intermediate visual acuity at variety targeted correction.
Defocus Curve
Measurement of a defocus curve
Eyhance IOL Group
Patients with bilateral implantation of EyhanceIOLs.
Visual Acuity
Measurement of distance and intermediate visual acuity at variety targeted correction.
Defocus Curve
Measurement of a defocus curve
Interventions
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Visual Acuity
Measurement of distance and intermediate visual acuity at variety targeted correction.
Defocus Curve
Measurement of a defocus curve
Eligibility Criteria
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Inclusion Criteria
2. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU\*\*\*).
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO
Exclusion Criteria
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. 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)
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye.
11. 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)
40 Years
ALL
Yes
Sponsors
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Berkeley Eye Center
OTHER
Responsible Party
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Principal Investigators
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Morgan Micheletti, MD
Role: PRINCIPAL_INVESTIGATOR
Berkeley Eye Center
Locations
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Berkeley Eye Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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69901155
Identifier Type: -
Identifier Source: org_study_id
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