Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Completed
Conditions studied: Pseudophakia
In brief
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
Key facts
- Study ID
- NCT05226884
- Run by
- Berkeley Eye Center
- People needed
- 310
- Starts
- 2021-11-30
- Expected to finish
- 2022-08-06
- Last updated by the study team
- 2024-11-15
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Berkeley Eye Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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