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| Name | Class |
|---|---|
| SiV Consulting | OTHER |
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The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR Toric | Experimental | Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSTOR Toric | Device | ReSTOR Toric bilateral IOL implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual Refractive Cylinder | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Uncorrected Near Visual Acuity | Monocular uncorrected near visual acuity measuring in logMAR | 3 months |
| Monocular Uncorrected Distance Visual Acuity | Monocular uncorrected distance visual acuity measured in logMAR notation |
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Inclusion Criteria:
Note: Ocular criteria must be met in the eligible eye.
Exclusion Criteria:
If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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| Name | Affiliation | Role |
|---|---|---|
| Clayton G Blehm, MD | Gainesville Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gainesville Eye Associates | Gainesville | Georgia | 30501 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR Toric | Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR Toric | Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation |
| 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 | Residual Refractive Cylinder | Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
3 months
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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 | ReSTOR Toric | Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. ReSTOR Toric: ReSTOR Toric bilateral IOL implantation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clayton Blehm, MD | Gainesville Eye Associates | 770-532-4444 | claytonblehm@gmail.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 | Aug 20, 2018 | Jul 14, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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This study is a prospective, single center, open clinical trial to collect normative performance data.
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| 3 months |
| Monocular Uncorrected Intermediate Visual Acuity | Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution) | 3 months |
| Monocular Best Corrected Distance Visual Acuity | Monocular best corrected distance visual acuity measured in logMAR notation | 3 months |
| Monocular Best Distance-corrected Intermediate Visual Acuity | Monocular best distance-corrected intermediate visual acuity in logMAR notation | 3 months |
| Monocular Best Distance-corrected Near Visual Acuity | Monocular best distance-corrected near visual acuity measured in logMAR notation | 3 months |
| Binocular Uncorrected Near Visual Acuity | Binocular uncorrected near (40cm) visual acuity measured in logMAR notation | 3 months |
| Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity measured in logMAR notation | 3 months |
| Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate (60cm) visual acuity | 3 months |
| Binocular Best-corrected Distance Visual Acuity | Binocular best-corrected distance visual acuity measured in logMAR notation | 3 months |
| Binocular Best Distance-corrected Intermediate Visual Acuity | Binocular best distance-corrected intermediate (60cm) visual acuity | 3 months |
| Binocular Best Distance-corrected Near Visual Acuity | Binocular best distance-corrected near (40cm) visual acuity | 3 months |
| IOL Orientation | Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp. | 3 months |
| Binocular Best Distance-corrected Defocus Curve | Binocular best distance-corrected defocus curve. | 3 months |
| Binocular Uncorrected Defocus Curve. | Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments | 3 months |
| Subjective Visual Quality | Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better. | 3 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Monocular Uncorrected Near Visual Acuity | Monocular uncorrected near visual acuity measuring in logMAR | Posted | Mean | Standard Deviation | logMAR | 3 months |
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|
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| Secondary | Monocular Uncorrected Distance Visual Acuity | Monocular uncorrected distance visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Monocular Uncorrected Intermediate Visual Acuity | Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution) | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Monocular Best Corrected Distance Visual Acuity | Monocular best corrected distance visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Monocular Best Distance-corrected Intermediate Visual Acuity | Monocular best distance-corrected intermediate visual acuity in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Monocular Best Distance-corrected Near Visual Acuity | Monocular best distance-corrected near visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Binocular Uncorrected Near Visual Acuity | Binocular uncorrected near (40cm) visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Binocular Uncorrected Distance Visual Acuity | Binocular uncorrected distance visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| Secondary | Binocular Uncorrected Intermediate Visual Acuity | Binocular uncorrected intermediate (60cm) visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| Secondary | Binocular Best-corrected Distance Visual Acuity | Binocular best-corrected distance visual acuity measured in logMAR notation | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| Secondary | Binocular Best Distance-corrected Intermediate Visual Acuity | Binocular best distance-corrected intermediate (60cm) visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Binocular Best Distance-corrected Near Visual Acuity | Binocular best distance-corrected near (40cm) visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | IOL Orientation | Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp. | Subjects are enrolled, eyes (2x subjects) were evaluated for some tests. | Posted | Number | Eyes with < 5 degrees rot'n from 1-3 mos | 3 months | Eyes | Eyes |
|
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| Secondary | Binocular Best Distance-corrected Defocus Curve | Binocular best distance-corrected defocus curve. | Posted | Mean | Standard Deviation | logMAR Acuity | 3 months |
|
|
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| Secondary | Binocular Uncorrected Defocus Curve. | Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments | Posted | Mean | Standard Deviation | logMAR Acuity | 3 months |
|
|
|
| Secondary | Subjective Visual Quality | Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better. | Posted | Median | Full Range | score on a Rasch scale (0-100) | 3 months |
|
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| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
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| Title |
|---|
| Measurements |
|---|
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| Defocus -4.00 |
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| Defocus -3.50 |
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| Defocus -3.00 |
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| Defocus -2.50 |
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| Defocus -2.00 |
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| Defocus -1.50 |
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| Defocus -1.00 |
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| Defocus -0.50 |
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| Title |
|---|
| Measurements |
|---|
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| Defocus -4.00 |
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| Defocus -3.50 |
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| Defocus -3.00 |
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| Defocus -2.50 |
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| Defocus -2.00 |
|
| Defocus -1.50 |
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| Defocus -1.00 |
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| Defocus -0.50 |
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| Title | Measurements |
|---|---|
|