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Completed

NCT Number: NCT05226884

Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Berkeley Eye Center

Houston, Texas, 77027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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)

Treatment and study plan

Visual Acuity

Diagnostic Test

Measurement of distance and intermediate visual acuity at variety targeted correction.

Defocus Curve

Diagnostic Test

Measurement of a defocus curve

Primary outcomes

  1. Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset

    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.

  2. Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity

    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.

  3. Non-inferiority of Best Corrected Distance Visual Acuity

    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.

  4. Binocular Distance Corrected Defocus Curve

    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.

  5. Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset

    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.

Secondary outcomes

  1. Post-operative Spherical Equivalent

    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.

  2. Postoperative Residual Astigmatism

    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.

Sponsors and collaborators

Lead sponsor

Berkeley Eye Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 7, 2022
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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