Trial Outcomes & Findings for Maximizing Visual Outcomes With Eyhance IOLs (NCT NCT05611073)
NCT ID: NCT05611073
Last Updated: 2025-05-23
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
110 participants
Primary outcome timeframe
1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
Results posted on
2025-05-23
Participant Flow
Participant milestones
| Measure |
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
61
|
|
Overall Study
COMPLETED
|
49
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=49 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=61 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 6.5 • n=49 Participants
|
69.8 years
STANDARD_DEVIATION 7.3 • n=61 Participants
|
69.8 years
STANDARD_DEVIATION 6.9 • n=110 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=49 Participants
|
24 Participants
n=61 Participants
|
58 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=49 Participants
|
37 Participants
n=61 Participants
|
52 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=49 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=61 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: 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.
|
0.03 logMAR
Standard Deviation 0.04
|
0.01 logMAR
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=49 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=61 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: 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 DCIVA (at 66 cm) of Patients With Bilateral Eyhance IOLs Corrected to Plano Sphere.
|
0.30 logMAR
Standard Deviation 0.07
|
0.12 logMAR
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)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.
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=98 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=122 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
Determine if Any Statistically Significant Differences in Pupil Size Exists Between the Two Groups.
|
4.16 mm
Standard Deviation 0.77
|
3.64 mm
Standard Deviation 0.77
|
SECONDARY outcome
Timeframe: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=98 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=122 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
Spherical Aberration Between Groups
|
0.29 microns (µm)
Standard Deviation 0.16
|
0.31 microns (µm)
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)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
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=98 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=122 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
Q Value Between Groups.
|
-0.34 Q value
Standard Deviation 0.23
|
-0.31 Q value
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)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.
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=98 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=122 eyes
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
Anterior Chamber Depth
|
3.25 mm
Standard Deviation 0.32
|
3.19 mm
Standard Deviation 0.41
|
|
Biometric Data (Anterior Chamber Depth and Axial Length) Between Groups.
Axial Length
|
24.33 mm
Standard Deviation 1.36
|
24.34 mm
Standard Deviation 1.52
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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 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.
Outcome measures
| Measure |
Distance With Minimal Intermediate Visual Acuity Group
n=49 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
Distance With Enhanced Intermediate/Near Visual Acuity Group
n=61 Participants
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.
Visual Acuity: Measurement of distance, intermediate and near visual acuity.
Biometric Data Collection: Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace.
Patient Questionnaire: Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction.
|
|---|---|---|
|
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.
Never experiencing glare, halos, or starbursts.
|
45 percentage of participants
|
66 percentage of participants
|
|
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.
Never using glasses for distance vision
|
69 percentage of participants
|
84 percentage of participants
|
|
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.
Never using glasses for intermediate vision
|
55 percentage of participants
|
59 percentage of participants
|
|
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.
Never using glasses for near vision
|
24 percentage of participants
|
30 percentage of participants
|
Adverse Events
Distance With Minimal Intermediate Visual Acuity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Distance With Enhanced Intermediate/Near Visual Acuity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place