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| Name | Class |
|---|---|
| Science in Vision | OTHER |
| Abbott Medical Optics | INDUSTRY |
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In July 2016, the FDA approved an extended depth of focus (EDOF) IOL (Tecnis Symfony, Abbott Medical Optics) helping to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery. It is available in both a non-toric version and a toric version for patients with astigmatism. The difference between this lens and the multifocal (MIOL) counterpart is that the EDOF, similarly to a monofocal IOL, has one focal point (elongated in the EDOF) while the multifocals have 2 focal points; therefore, having less of a halo and glare problem. Pivotal trial results where Symfony was compared to a monofocal IOL showed similar uncorrected distance visual acuity (UCDVA), better intermediate (77% vs. 34% 20/25 uncorrected intermediate visual acuity - UCIVA) and near vision (Symfony patients were able to read two additional, progressively smaller lines compared to the monofocal IOL).A One potential disadvantage of the EDOF IOL compared to a MIOL is the visual performance at near.B One option to deal with this potential shortcoming is to set the non-dominant eye for a small residual myopic error (-0.50 D)C what is referred to as nano-vision or mini mono-vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emmetropia both eyes (OU) group | Active Comparator | Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). |
|
| Nanovision group | Experimental | Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Presbyopia and astigmatism correcting intraocular lens | Device | The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance-corrected Near (40 cm) Visual Acuity. | Visual acuity with correction (glasses) measured at 40 cm. | 3 months |
| Reduction of Manifest Cylinder (Diopters). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uncorrected Near (40 cm) Visual Acuity | Visual acuity without correction (no glasses) measured at 40 cm. | 3 months |
| Uncorrected Intermediate (66 cm) Visual Acuity | Visual acuity without correction (no glasses) measured at 66 cm. |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Mean Spherical Equivalent Refraction | 3 months | |
| Residual Refractive Sphere | 3 months | |
| Residual Refractive Cylinder |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry D. Solomon, MD | Carolina Eyecare Physicians, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Eye Care | Stillwater | Minnesota | 55082 | United States | ||
| Ophthalmic Consultants of Long Island |
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A total of 120 patients were enrolled and randomized; however, data from only 79 patients was analyzed due to major procedural issues at one site. One patient in the Emmetropia group missed the 3-month visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emmetropia Both Eyes (OU) Group | Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
| FG001 | Nanovision Group | Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emmetropia Both Eyes (OU) Group | Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
| 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 | Binocular Distance-corrected Near (40 cm) Visual Acuity. | Visual acuity with correction (glasses) measured at 40 cm. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
Average 3 months. Adverse events were collected from the moment patient enrolled in the study until exit.
Only eye related events were collected.
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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 | Emmetropia Both Eyes (OU) Group | Symfony Toric IOL target refraction both eyes emmetropia (±0.25D). Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helga P Sandoval, Director of Research | Carolina Eyecare Physicians, LLC | 8438813937 | helga.sandoval@carolinaeyecare.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 | May 31, 2017 | Jan 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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|
| 3 months |
| Uncorrected (4 m) Visual Acuity | Visual acuity without correction (no glasses) measured at 4 m. | 3 months |
| Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) | Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire. | 3 months |
| Patient Reported Spectacle Independence Questionnaire | Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire. | 3 months |
| 3 months |
| Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D | 3 months |
| Garden City |
| New York |
| 11530 |
| United States |
| Carolina Eyecare Physicians, LLC | Mt. Pleasant | South Carolina | 29464 | United States |
| Slade & Baker Vision Center | Houston | Texas | 77027 | United States |
| BG001 | Nanovision Group | Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D.
Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
|
|
| Primary | Reduction of Manifest Cylinder (Diopters). | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Secondary | Uncorrected Near (40 cm) Visual Acuity | Visual acuity without correction (no glasses) measured at 40 cm. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Secondary | Uncorrected Intermediate (66 cm) Visual Acuity | Visual acuity without correction (no glasses) measured at 66 cm. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Secondary | Uncorrected (4 m) Visual Acuity | Visual acuity without correction (no glasses) measured at 4 m. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Secondary | Modified Patient-Reported Visual Symptoms Questionnaire (PRVSQ) | Percentage of patients who reported any visual symptoms such as halos, glare, starburst, light sensitivity when answering the self administered questionnaire. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Number | percentage of participants | 3 months |
|
|
|
| Secondary | Patient Reported Spectacle Independence Questionnaire | Percentage of participants who reported wearing glasses none or a little of the time in the self administered questionnaire. | One subject in the emmetropia group missed the Month 3 visit. | Posted | Number | percentage of participants | 3 months |
|
|
|
| Other Pre-specified | Residual Mean Spherical Equivalent Refraction | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
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| Other Pre-specified | Residual Refractive Sphere | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Other Pre-specified | Residual Refractive Cylinder | One subject in the emmetropia group missed the Month 3 visit. | Posted | Mean | Standard Deviation | diopters | 3 months |
|
|
|
| Other Pre-specified | Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Accuracy to Target ≤ 0.5D | One subject in the emmetropia group missed the Month 3 visit. | Posted | Number | percentage of eyes | 3 months | Eyes | Eyes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Nanovision Group | Symfony Toric IOL target refraction for the dominant eye will be plano (±0.25D) and for the non-dominant eye -0.50 ±0.16 D. Presbyopia and astigmatism correcting intraocular lens: The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism. | 0 | 39 | 0 | 39 | 0 | 39 |
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