An observational study in Pseudophakia, sponsored by Berkeley Eye Center. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by Berkeley Eye Center · Observational
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.
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.
54 studies on the registry are indexed under Pseudophakia; 8 are open to participants now.
This study's enrollment of 110 is above the median of 71 across 26 observational studies indexed under Pseudophakia.
Browse Pseudophakia studies →Berkeley Eye Center is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance IOLs.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Visual Acuity · Diagnostic Test: Biometric Data Collection · Other: Patient Questionnaire
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.
Diagnostic Test: Visual Acuity · Diagnostic Test: Biometric Data Collection · Other: Patient Questionnaire
Measurement of distance, intermediate and near visual acuity.
Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
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.
Time frame: 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.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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.
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.
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
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.
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.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Comparison of a Patient Satisfaction Survey Between the Two Groups to Assess for Subjective Differences in Everyday Life. Patient's Answers Will be on a Scale Between Always and Never, Where Never Shows a Better Patient Outcome.
Comparison of a patient satisfaction survey between the two groups to assess for subjective differences in everyday life to determine if the enhanced vision plays a statistically significant difference in patient's perceived quality of vision or quality of life. Patient's answers will be on a scale between always and never, where never shows a better patient outcome.
Time frame: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
| Milestone | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Started | 49 | 61 |
| Completed | 49 | 61 |
| Not completed | 0 | 0 |
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.
| logMAR | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| 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. | 0.03 ± 0.04 | 0.01 ± 0.02 |
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.
| logMAR | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| 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. | 0.30 ± 0.07 | 0.12 ± 0.07 |
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.
| mm | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups. | 4.16 ± 0.77 | 3.64 ± 0.77 |
| microns (µm) | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Spherical Aberration Between Groups | 0.29 ± 0.16 | 0.31 ± 0.15 |
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
| Q value | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Q Value Between Groups. | -0.34 ± 0.23 | -0.31 ± 0.18 |
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.
| mm | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Anterior Chamber Depth | 3.25 ± 0.32 | 3.19 ± 0.41 |
| Axial Length | 24.33 ± 1.36 | 24.34 ± 1.52 |
Comparison of a patient satisfaction survey between the two groups to assess for subjective differences in everyday life to determine if the enhanced vision plays a statistically significant difference in patient's perceived quality of vision or quality of life. Patient's answers will be on a scale between always and never, where never shows a better patient outcome.
| percentage of participants | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group |
|---|---|---|
| Never experiencing glare, halos, or starbursts. | 45 | 66 |
| Never using glasses for distance vision | 69 | 84 |
| Never using glasses for intermediate vision | 55 | 59 |
| Never using glasses for near vision | 24 | 30 |
Collected over 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Distance With Minimal Intermediate Visual Acuity Group | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Distance With Enhanced Intermediate/Near Visual Acuity Group | 0/61 (0%) | 0/61 (0%) | 0/61 (0%) |
| Age, Continuous(years) | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group | Total |
|---|---|---|---|
| Mean | 69.6 ± 6.5 | 69.8 ± 7.3 | 69.8 ± 6.9 |
| Sex: Female, Male(Participants) | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group | Total |
|---|---|---|---|
| Female | 34 | 24 | 58 |
| Male | 15 | 37 | 52 |
| Race and Ethnicity Not Collected(Participants) | Distance With Minimal Intermediate Visual Acuity Group | Distance With Enhanced Intermediate/Near Visual Acuity Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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