Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon IOL Group | Patients with bilateral implantation of Clareon IOLs. |
| |
| Eyhance IOL Group | Patients with bilateral implantation of EyhanceIOLs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual Acuity | Diagnostic Test | Measurement of distance and intermediate visual acuity at variety targeted correction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Spherical Equivalent | Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects. | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
| Postoperative Residual Astigmatism |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients with healthy eyes and uncomplicated bilateral implantation of Eyhance intraocular lenses or Clareon intraocular lenses.
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Clareon IOL Group | Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria. Visual Acuity: Measurement of distance and intermediate visual acuities Defocus Curve: Measurement of a defocus curve Refraction: Measurement of residual astigmatism and spherical equivalent. |
| FG001 | Eyhance IOL Group | Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria. Visual Acuity: Measurement of distance and intermediate visual acuities Defocus Curve: Measurement of a defocus curve Refraction: Measurement of residual astigmatism and spherical equivalent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clareon IOL Group | Patients with bilateral implantation of Clareon IOLs who meet the inclusion/exclusion criteria. Visual Acuity: Measurement of distance and intermediate visual acuities Defocus Curve: Measurement of a defocus curve Refraction: Measurement of residual astigmatism and spherical equivalent. |
| BG001 |
| 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 | 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. | Posted | Mean | Standard Deviation | LogMAR | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
Single (1 hour) visit
Single visit, non-interventional study, meaning only visual acuity measurements were collected during a 1-hour study visit. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were assessed but none were observed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clareon IOL Group | Patients with bilateral implantation of Clareon IOLs. Visual Acuity: Measurement of distance and intermediate visual acuity at variety targeted correction. Defocus Curve: Measurement of a defocus curve |
Not provided
Not provided
As this was a study on subjects who had already undergone cataract surgery, pre-operative targeting was not controlled for and based on patient discussions (e.g. mini-monovision, monovision, emmetropia). However, measuring visual acuities with distance correction allowed for a head-to-head comparison without residual postoperative refractive error as a confounding factor. Another potential limitation was that Eyhance torics were included, but the Clareon toric was not available.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Hill | Clinical Research Coordinator | 713-526-1600 | diana.hill@berkeleyeye.com |
Not provided
| 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 17, 2022 | Apr 19, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| Defocus Curve | Diagnostic Test | Measurement of a defocus curve |
|
Target-corrected binocular distance (4 m) visual acuity of Clareon monofocal subjects at -0.25 sphere versus Eyhance subjects at plano sphere. |
| Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects.
| Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
| Eyhance IOL Group |
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria. Visual Acuity: Measurement of distance and intermediate visual acuities Defocus Curve: Measurement of a defocus curve Refraction: Measurement of residual astigmatism and spherical equivalent. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Axial Length | Axial length is obtained using an optical biometer prior to surgery and is a factor used to determine the power of the IOL to be implanted. | Mean | Standard Deviation | millimeters |
|
| IOL Power | IOL power is determined using an optical biometer which takes various measurements of the eye to determine the lens power that should present the best visual outcome for the patient postoperatively. | Mean | Standard Deviation | Diopters |
|
| Corneal Astigmatism | Corneal astigmatism is the measure of the curvature of the cornea, which affects the way light is refracted which can cause a blurry image. Corneal astigmatism is measured during a refraction using a phoropter. | Mean | Standard Deviation | diopters |
|
| Anterior Chamber Depth | Anterior chamber depth is obtained using an optical biometer prior to surgery and is a factor used to determine the power of the IOL to be implanted. | Mean | Standard Deviation | millimeters |
|
| Pupil Size | Pupil size is obtained using an optical biometer prior to surgery and is a factor used to determine the power of the IOL to be implanted. | Mean | Standard Deviation | millimeters |
|
| Target/Aim | Diopter is a unit of measurement of the optical power of a lens, which is equal to the reciprocal of the focal length measured in meters. The target/aim is the goal for the visual outcome post-operatively. This may differ for each patient because it is based on lifestyle needs. | Mean | Standard Deviation | diopters |
|
| Predicted Post-operative Spherical Equivalent | Spherical equivalent is the estimate of each eye's refractive error. Predicted post-operative spherical equivalent is obtained using an optical biometer prior to surgery and is a factor used to determine the power of the IOL to be implanted. | Mean | Standard Deviation | diopters |
|
| Average Corneal Power | Mean | Standard Deviation | Diopters |
|
Patients with bilateral implantation of Eyhance IOLs who meet the inclusion/exclusion criteria.
Visual Acuity: Measurement of distance and intermediate visual acuities
Defocus Curve: Measurement of a defocus curve
Refraction: Measurement of residual astigmatism and spherical equivalent.
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | LogMAR | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
|
| Primary | Non-inferiority of Best Corrected Distance Visual Acuity | Comparison of Best Corrected Distance Visual Acuity (measured at 4m) of Clareon subjects versus Eyhance subjects. | Posted | Mean | Standard Deviation | LogMAR | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | LogMAR | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | LogMAR | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
|
| Secondary | Post-operative Spherical Equivalent | Comparison of the Post-operative Spherical Equivalent of Clareon subjects versus Eyhance subjects. | Posted | Mean | Standard Deviation | Diopters | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
| Secondary | Postoperative Residual Astigmatism | Comparison of the amount of residual astigmatism of Clareon subjects versus Eyhance subjects. | Posted | Mean | Standard Deviation | Diopters | Minimum of 3 months post-operatively from cataract surgery, up to 2 years |
|
|
|
| 0 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | Eyhance IOL Group | Patients with bilateral implantation of EyhanceIOLs. Visual Acuity: Measurement of distance and intermediate visual acuity at variety targeted correction. Defocus Curve: Measurement of a defocus curve | 0 | 155 | 0 | 155 | 0 | 155 |
Not provided
Not provided
| D009799 | Ocular Physiological Phenomena |
| -2.0 D |
|
| -1.5 D |
|
| -1.0 D |
|
| -0.5 D |
|
| -0.25 D |
|
| 0 D |
|
| 0.25 D |
|
| 0.5 D |
|
| 1 D |
|