CompletedNot Applicable

Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

United States310 participantsStarted 2021-11-30

Plain-language summary

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

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity

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

Non-inferiority of Best Corrected Distance Visual Acuity

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

Binocular Distance Corrected Defocus Curve

Timeframe: 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

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

Trial details

NCT IDNCT05226884

SponsorBerkeley Eye Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-06

Results submitted2023-08-24

View on ClinicalTrials.gov More Pseudophakia trials

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity

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

Non-inferiority of Best Corrected Distance Visual Acuity

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

Binocular Distance Corrected Defocus Curve

Timeframe: 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

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