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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity | Diagnostic Test | Measurement of distance, intermediate and near visual acuity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance IOLs.
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| Name | Affiliation | Role |
|---|---|---|
| Morgan Micheletti, MD | Berkeley Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center | Houston | Texas | 77027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | logMAR | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
|
1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tetiana Huff | Berkeley Eye Center | 713-620-7640 | tetiana.huff@berkeleyeye.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 25, 2022 | Mar 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| D000073222 | Patient Health Questionnaire |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Biometric Data Collection | Diagnostic Test | Measurement of biometric data will be obtained from the Zeiss IOL Master 700, Atlas 9000, and the iTrace. |
|
| Patient Questionnaire | Other | Patients will complete a Patient Questionnaire to determine their level of spectacle independence and visual acuity satisfaction. |
|
| 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
| Spherical Aberration Between Groups | 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.
| 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. | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
| 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | logMAR | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) | eyes | eyes |
|
|
|
| Secondary | Spherical Aberration Between Groups | Posted | Mean | Standard Deviation | microns (µm) | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) | eyes | eyes |
|
|
|
| Secondary | Q Value Between Groups. | Q-value is an assessment of corneal asphericity.
| Posted | Mean | Standard Deviation | Q value | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) | eyes | eyes |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) | eyes | eyes |
|
|
|
| Other Pre-specified | 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. | Posted | Number | percentage of participants | 1 day (between a minimum of 3 weeks postoperative up to 26 weeks post-operative) |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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. | 0 | 61 | 0 | 61 | 0 | 61 |
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| D009799 | Ocular Physiological Phenomena |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Never using glasses for intermediate vision |
|
| Never using glasses for near vision |
|