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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This study is a single center, ambispective study of visual outcomes after successful bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a single visit. Clinical evaluations will include administration of the AIOLIS and OSDI questionnaires, as well as measurement of visual acuities at distance, intermediate, and near.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS Odyssey IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS Odyssey IOL | Device | Implantation with the TECNIS Odyssey IOL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity at Distance (6m) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | 3 months postoperative |
| Visual Acuity at Intermediate (66cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | 3 months postoperative |
| Visual Acuity at Near (40cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | 3 months postoperative |
| Visual Acuity at Near (33cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare | The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. | 3 months postoperative |
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Inclusion Criteria:
• Patients aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
Exclusion Criteria:
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Eligible test subjects will be aged 50 years and older who underwent bilateral cataract surgery with Odyssey IOL implantation.
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Brunson, OD | Mann Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mann Eye Institute | Houston | Texas | 76134-2099 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TECNIS Odyssey IOL | TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TECNIS Odyssey IOL | TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL |
| 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 | Visual Acuity at Distance (6m) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | Posted | Mean | Standard Deviation | logMAR | 3 months postoperative | Eyes | Eyes |
|
|
1 day
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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 | TECNIS Odyssey IOL | TECNIS Odyssey IOL: Implantation with the TECNIS Odyssey IOL |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phillip Brunson | Mann Eye Institute | 1-713-580-2500 | pbrunson@manneye.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 7, 2024 | Feb 25, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 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 |
|
| Eyes |
|
|
| Primary | Visual Acuity at Intermediate (66cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | Posted | Mean | Standard Deviation | logMAR | 3 months postoperative | eyes | eyes |
|
|
|
| Primary | Visual Acuity at Near (40cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | Posted | Mean | Standard Deviation | logMAR | 3 months postoperative | eyes | eyes |
|
|
|
| Primary | Visual Acuity at Near (33cm) logMAR | Photopic and mesopic, binocular and monocular, and uncorrected and distance corrected | Posted | Mean | Standard Deviation | logMAR | 3 months postoperative | eyes | eyes |
|
|
|
| Secondary | Assessment of IntraOcular Lens Implant Symptoms (AIOLIS) Questionniare | The AIOLIS has 37 questions about symptoms, perceptions of general vision, and frequency of wearing glasses or contact lenses. Perceptions about general vision are asked on a 5 item scale (Poor, Fair, Good, Very good, Excellent). Poor is considered a worse outcome. | Posted | Count of Participants | Participants | 3 months postoperative |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| Title | Measurements |
|---|---|
|
| Monocular mesopic DCIVA |
|
| Binocular photopic UIVA |
|
| Binocular photopic DCIVA |
|
| Binocular mesopic UIVA |
|
| Binocular mesopic DCIVA |
|
| Title | Measurements |
|---|---|
|
| Monocular mesopic DCNVA |
|
| Binocular photopic UNVA |
|
| Binocular photopic DCNVA |
|
| Binocular mesopic UNVA |
|
| Binocular mesopic DCNVA |
|
| Title | Measurements |
|---|---|
|
| Monocular mesopic DCNVA |
|
| Binocular photopic UNVA |
|
| Binocular photopic DCNVA |
|
| Binocular mesopic UNVA |
|
| Binocular mesopic DCNVA |
|
| Title | Measurements |
|---|---|
|
| Near vision rated as "Excellent" or "Very Good" |
|