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 range

40 Years

Sex

ALL

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

40 Years

Sex

ALL

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)

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