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.

Study Overview

• Status: Completed
• Conditions: Pseudophakia
• Intervention / Treatment: Diagnostic test: Visual Acuity; Diagnostic test: Defocus Curve

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 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.

• Study Type: Observational
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77027
      • Berkeley Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.

Description

Inclusion Criteria:

1. Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes.
2. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU***).
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO

Exclusion Criteria:

1. 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
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. 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)
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye.
11. 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clareon IOL Group; Patients with bilateral implantation of Clareon IOLs.	Diagnostic test: Visual Acuity; Measurement of distance and intermediate visual acuity at variety targeted correction.; Diagnostic test: Defocus Curve; Measurement of a defocus curve
Eyhance IOL Group; Patients with bilateral implantation of EyhanceIOLs.	Diagnostic test: Visual Acuity; Measurement of distance and intermediate visual acuity at variety targeted correction.; Diagnostic test: Defocus Curve; Measurement of a defocus curve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset	Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity	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.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Non-inferiority of Best Corrected Distance Visual Acuity	Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Binocular Distance Corrected Defocus Curve	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.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset	Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Spherical Equivalent	Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Postoperative Residual Astigmatism	Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.	Minimum of 3 months post-operatively from cataract surgery, up to 2 years

Collaborators and Investigators

• Sponsor: Berkeley Eye Center
• Investigators: Principal Investigator: Morgan Micheletti, MD, Berkeley Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): August 6, 2022
• Study Completion (Actual): August 6, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Clareon; Eyhance; pseudophakia
• Additional Relevant MeSH Terms: Pseudophakia
• Other Study ID Numbers: 69901155

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No