Clinical trial NCT05226884: Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Official title: Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pseudophakia
Keywords: Clareon
Eyhance
pseudophakia
Lead sponsor: Berkeley Eye Center
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 310
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.

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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
measure: Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
measure: Non-inferiority of Best Corrected Distance Visual Acuity
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
measure: Binocular Distance Corrected Defocus Curve
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
measure: Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Secondary outcomes:
measure: Post-operative Spherical Equivalent
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
measure: Postoperative Residual Astigmatism
timeFrame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
Study officials:
affiliation: Berkeley Eye Center
name: Morgan Micheletti, MD
role: PRINCIPAL_INVESTIGATOR
References: