Maximizing Visual Outcomes With Eyhance IOLs

Completed

Conditions studied: Pseudophakia

In brief

This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction.

Key facts

Study ID

NCT05611073

Run by

Berkeley Eye Center

People needed

110

Starts

2022-03-07

Expected to finish

2022-11-07

Last updated by the study team

2025-05-23

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 Eyhance IOLs (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 YAG 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 or predisposition to retinal conditions.
• 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).
• 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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