Status:
COMPLETED
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Lead Sponsor:
Berkeley Eye Center
Conditions:
Pseudophakia
Eligibility:
All Genders
40+ years
Brief Summary
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
Detailed Description
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 E...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2022
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT05226884
Start Date
November 30 2021
End Date
August 6 2022
Last Update
November 15 2024
Active Locations (1)
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1
Berkeley Eye Center
Houston, Texas, United States, 77027