Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

NCT05226884 | Completed Results FDA Device

• 1 other identifier: 69901155
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pseudophakia

Keywords

Clareon; Eyhance; pseudophakia

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Post-operative Spherical Equivalent

  Minimum of 3 months post-operatively from cataract surgery, up to 2 years

• Postoperative Residual Astigmatism

  Minimum of 3 months post-operatively from cataract surgery, up to 2 years

Study Arms (2)

Clareon IOL Group

Patients with bilateral implantation of Clareon IOLs.

Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve

Eyhance IOL Group

Patients with bilateral implantation of EyhanceIOLs.

Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve

Interventions

Visual Acuity DIAGNOSTIC_TEST

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

Clareon IOL Group; Eyhance IOL Group

Defocus Curve DIAGNOSTIC_TEST

Measurement of a defocus curve

Clareon IOL Group; Eyhance IOL Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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)

Sponsors & Collaborators

• Berkeley Eye Center: lead

Study Sites (1)

Berkeley Eye Center

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Pseudophakia

Interventions

Visual Acuity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vision Tests; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Ocular Physiological Phenomena

Limitations and Caveats

As this was a study on subjects who had already undergone cataract surgery, pre-operative targeting was not controlled for and based on patient discussions (e.g. mini-monovision, monovision, emmetropia). However, measuring visual acuities with distance correction allowed for a head-to-head comparison without residual postoperative refractive error as a confounding factor. Another potential limitation was that Eyhance torics were included, but the Clareon toric was not available.

Results Point of Contact

• Title: Diana Hill
• Organization: Clinical Research Coordinator

diana.hill@berkeleyeye.com

713-526-1600

Study Officials

• Morgan Micheletti, MD

  Berkeley Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 7, 2022
• Study Start: November 30, 2021
• Primary Completion: August 6, 2022
• Study Completion: August 6, 2022
• Last Updated: November 15, 2024
• Results First Posted: November 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)