PseudophakiaNCT05611073
Maximizing Visual Outcomes With Eyhance IOLs
An observational study of Pseudophakia, run by Berkeley Eye Center at 1 site in United States.
Trial summary
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. 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, Biometric Data Collection and Patient Questionnaire
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2022to 7 Nov 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 IOLs.
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 Eyhance IOLs (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 YAG 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 or predisposition to retinal conditions.
- 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).
- 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
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction.
Read the detailed description
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be assessed in the 1-6-month post-operative period. Patients will be grouped into two arms: "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA and DCIVA (at 66 cm) of patients with bilateral Eyhance IOLs corrected to plano sphere. The "distance with minimal intermediate" group is defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. The "distance with enhanced intermediate/near" is defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. In addition to binocular BCDVA and DCIVA, monocular measurements will be obtained as well. The two groups will be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction. Biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
- Conditions
- Pseudophakia
- Being tested
- Visual Acuity, Biometric Data Collection, Patient Questionnaire
- Keywords
- 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, intermediate and near visual acuity.
Biometric Data CollectionDiagnostic test
Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient QuestionnaireOther
Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Distance with Minimal Intermediate Visual Acuity Group | Patients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Biometric Data Collection; Other: Patient Questionnaire | |
| Distance with Enhanced Intermediate/Near Visual Acuity Group | Patients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. Receives: Diagnostic Test: Visual Acuity; Diagnostic Test: Biometric Data Collection; Other: Patient Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular DCIVA (at 66 cm) of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Secondary outcomes (4)
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.
To determine if any statistically significant differences in pupil size exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Spherical Aberration Between Groups
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Q Value Between Groups.
Q-value is an assessment of corneal asphericity.
- A value of 0 indicates a cornea that is perfectly spherical
- A value between -1 and 0 indicates a cornea that is shaped more like a football
- A value between 0 and 1 indicates a cornea that is shaped more like a dish
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
To determine if any statistically significant differences in biometric data exists between the two groups that may allow for pre-operative recognition of those patients who could have enhanced benefits of the Eyhance IOL. This will require multiple regression analysis given the large number of variables.
Measured: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start7 Mar 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 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
- 110 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
- NCT05611073
- Sponsor's protocol ID
- JMM-1261
- Status last verified
- May 2025
- First submitted
- 12 Jul 2022
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Visual Outcomes With Eyhance IOLs
- ClinicalTrials.gov ID
- NCT05611073
- Acronym / sponsor ID
- JMM-1261
- Conditions
- Pseudophakia
- Keywords
- Eyhance, Pseudophakia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Posted 23 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction.
Detailed description
This is a non-interventional prospective, single center, bilateral, non-randomized, open-label, observational clinical study. All patients will have had bilateral implantation of an Eyhance IOL at the time of cataract surgery. These patients will then be assessed in the 1-6-month post-operative period. Patients will be grouped into two arms: "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA and DCIVA (at 66 cm) of patients with bilateral Eyhance IOLs corrected to plano sphere. The "distance with minimal intermediate" group is defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. The "distance with enhanced intermediate/near" is defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. In addition to binocular BCDVA and DCIVA, monocular measurements will be obtained as well. The two groups will be compared to assess which patient biometric properties (such as spherical aberration, q value, pupil size, etc.) lead to an overall increase in near or intermediate vision as well as overall patient satisfaction. Biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distance with Minimal Intermediate Visual Acuity Group | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Biometric Data Collection, Other: Patient QuestionnairePatients with bilateral implantation of Eyhance IOLs. And defined by BCDVA of 0.1 logMAR or better but a DCIVA of 0.4 logMAR or worse. |
| Distance with Enhanced Intermediate/Near Visual Acuity Group | – | Diagnostic Test: Visual Acuity, Diagnostic Test: Biometric Data Collection, Other: Patient QuestionnairePatients with bilateral implantation of Eyhance IOLS. And defined by BCDVA of 0.1 logMAR or better and a DCIVA of 0.3 logMAR or better. |
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 IOLs.
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 Eyhance IOLs (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 or predisposition to retinal conditions.
- 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, intermediate and near visual acuity. | Diagnostic test | Distance with Enhanced Intermediate/Near Visual Acuity Group, Distance with Minimal Intermediate Visual Acuity Group |
| Biometric Data CollectionMeasurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace. | Diagnostic test | Distance with Enhanced Intermediate/Near Visual Acuity Group, Distance with Minimal Intermediate Visual Acuity Group |
| Patient QuestionnairePatients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction. | Other | Distance with Enhanced Intermediate/Near Visual Acuity Group, Distance with Minimal Intermediate Visual Acuity Group |
Primary outcome
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular BCDVA of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular DCIVA (at 66 cm) of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
To compare two groups categorized by "distance with minimal intermediate" and "distance with enhanced intermediate/near" based on mean photopic binocular DCIVA (66 cm) of patients with bilateral Eyhance IOLs targeted corrected at plano sphere.
4 secondary outcomes
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Spherical Aberration Between Groups
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Q Value Between Groups.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 23 May 2025. 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 23 May 2025). 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?
Comparison of Two Groups Categorized by "Distance With Minimal Intermediate" and "Distance With Enhanced Intermediate/Near" Based on Mean Photopic Binocular BCDVA of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere. (time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)). The study lists 2 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 23 May 2025.