PseudophakiaNCT05226884
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
Trial summary
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pseudophakia
- What is being tested?
- Visual Acuity and Defocus Curve
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 6 Aug 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
Read the 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.
- Conditions
- Pseudophakia
- Being tested
- Visual Acuity, Defocus Curve
- Keywords
- Clareon, Eyhance, pseudophakia
- Medical subject headings
- Pseudophakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual AcuityDiagnostic test
Measurement of distance and intermediate visual acuity at variety targeted correction.
Defocus CurveDiagnostic test
Measurement of a defocus curve
| Study group | Role | What they receive |
|---|---|---|
| Clareon IOL Group | Patients with bilateral implantation of Clareon IOLs. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve | |
| Eyhance IOL Group | Patients with bilateral implantation of EyhanceIOLs. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Defocus Curve |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Secondary outcomes (2)
Post-operative Spherical Equivalent
Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects.
Measured: 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.
Measured: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start30 Nov 2021
- Primary completion6 Aug 2022
- Study completion6 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PseudophakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 310 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan Micheletti, MD, Principal investigator, Berkeley Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226884
- Sponsor's protocol ID
- 69901155
- Status last verified
- Sep 2024
- First submitted
- 4 Jan 2022
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs
- ClinicalTrials.gov ID
- NCT05226884
- Acronym / sponsor ID
- 69901155
- Conditions
- Pseudophakia
- Keywords
- Clareon, Eyhance, pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 6 Aug 2022 (actual)
- Study completion
- 6 Aug 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon IOL Group | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Defocus CurvePatients with bilateral implantation of Clareon IOLs. |
| Eyhance IOL Group | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Defocus CurvePatients with bilateral implantation of EyhanceIOLs. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual AcuityMeasurement of distance and intermediate visual acuity at variety targeted correction. | Diagnostic test | Clareon IOL Group, Eyhance IOL Group |
| Defocus CurveMeasurement of a defocus curve | Diagnostic test | Clareon IOL Group, Eyhance IOL Group |
Primary outcome
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular intermediate (66 cm) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
Non-inferiority of Distance Corrected Binocular Intermediate Visual Acuity
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
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.
Non-inferiority of Best Corrected Distance Visual Acuity
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects.
Binocular Distance Corrected Defocus Curve
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
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.
Non-inferiority of Target-corrected Binocular Distance (4 m) Visual Acuity With Offset
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere.
2 secondary outcomes
Post-operative Spherical Equivalent
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Postoperative Residual Astigmatism
Time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pseudophakia
RecruitingObservational study
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Dysphotopsia, Posterior Capsule Opacification
Not yet recruitingObservational study
IOL Position and Refractive Change After Nd:YAG Laser Posterior Capsulotomy
Posterior Capsule Opacification, Pseudophakia
Enrolling by invitation
Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Pseudophakia, Myopia
Enrolling by invitation
Treatment of Residual Refraction Errors 6 Months After Trifocal IOL Implantation With Relex-Smile
Pseudophakia, Myopia
Active, not recruiting
Treatment of Residual Hypermetropic Refraction on Pseudophakic Patients Using Allogenic Fresh Myopic Lenticule
Pseudophakia, Hypermetropia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan Micheletti, MD principal investigator
Berkeley Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority of Target-corrected Binocular Intermediate (66 cm) Visual Acuity With Offset (time frame: Minimum of 3 months post-operatively from cataract surgery, up to 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.