Berkeley Eye Center
Houston, Texas, 77027, United States
NCT Number: NCT05226884
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
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Notify Me40 year and older
All sexes
Observational
Houston, Texas, 77027, United States
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 compare distance and intermediate visual acuities and a defocus curve in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
Patients will be assessed for corrected binocular distance and intermediate vision.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measurement of distance and intermediate visual acuity at variety targeted correction.
Measurement of a defocus curve
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Distance corrected binocular intermediate visual acuity (measured at 66 cm) of Clareon subjects versus Eyhance subjects with both groups set at plano sphere. Non-inferiority defined as 1 line.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
The Binocular Distance Corrected Defocus Curve measures visual acuity across simulated distances (+1.0D to -3.0D) in subjects with intraocular lenses (IOLs) post-cataract surgery. Testing begins with the best corrected visual acuity (BCVA), and the patient's refractive error is entered into the phoropter as the 0 position. Defocus lenses are introduced in 0.5D increments to simulate various distances. Visual acuity is measured binocularly at each level using standardized charts (e.g., ETDRS, Snellen) and recorded in logMAR. Measurements are taken at least 3 months post-op under standardized lighting conditions to evaluate visual performance across the defocus range in IOL patients.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.
Berkeley Eye Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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