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This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.
The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Lens | Experimental | Tecnis Eyhance |
|
| Control Lens | Active Comparator | Tecnis 1 piece IOL (Intraocular lens) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis Eyhance | Device | Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups | 6 months |
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Inclusion Criteria:
Minimum 22 years of age
Bilateral cataracts for which posterior chamber IOL implantation has been planned
Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
Potential for postoperative best corrected visual acuity of 20/30 Snellen or better
Corneal astigmatism parameters:
Clear intraocular media other than cataract in each eye
Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
Ability to understand and respond to a questionnaire in English
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Southern California Eye Physicians and Associates |
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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A total of 228 subjects were enrolled and 214 subjects were treated. Of the 214 subjects, 107 were implanted with the test lens and 107 with the control lens. 4 subjects did not complete the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens | Eyhance IOL, Model DIB00 |
| FG001 | Control Lens | Monofocal IOL, Model ZCB00 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2022 | Jun 1, 2023 |
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| Tecnis 1 piece IOL | Device | Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
|
| Long Beach |
| California |
| 90805 |
| United States |
| Center For Sight | Sarasota | Florida | 34239 | United States |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | United States |
| Chesapeake Eye Care & Laser Center | Annapolis | Maryland | 21401 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16606 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Berkeley Eye Institute, P.A. | Houston | Texas | 77027 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Texas Eye and Laser Center | Hurst | Texas | 76054 | United States |
| Focal Point Vision | San Antonio | Texas | 78209 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| R & R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Lens | Eyhance IOL, Model DIB00 |
| BG001 | Control Lens | Monofocal IOL, Model ZCB00 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 | MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA) | the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups | The ITT (Intent-to-Treat) population for Monocular Best Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation) | Posted | Mean | Standard Deviation | LogMAR | 6 months | Eyes | Eyes |
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| Secondary | MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66) | the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups | The ITT (Intent-to-Treat) population for monocular first-eye distance-corrected intermediate visual acuity at 66cm (DCVA66) include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation). | Posted | Mean | Standard Deviation | LogMAR | 6 months | Eyes | Eyes |
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During the course of the study until completion, 6 months.
All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for the first eye only. Second eye was not assessed for adverse events.
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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 | Test Lens | Eyhance IOL, Model DIB00 | 2 | 107 | 5 | 107 | 1 | 107 |
| EG001 | Control Lens | Monofocal IOL, Model ZCB00 | 0 | 107 | 4 | 107 | 0 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid macular edema | Eye disorders | Non-systematic Assessment |
| ||
| Lymphoma | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Refractory Cytopenia with Multilineage Dysplasia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Mitral Valve Defect | Cardiac disorders | Non-systematic Assessment |
| ||
| Ischemic Optic Neuropathy | Eye disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Undesirable Optical Phenomena | Eye disorders | Non-systematic Assessment |
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The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Vargas, MD | Johnson & Johnson Surgical Vision | 714-247-8200 | LVarga17@ITS.JNJ.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2022 | Jun 1, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
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| 70-79 |
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| >=80 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Native Hawaiian/ Pacific Islander |
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| Caucasian |
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| Other Race |
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| Eyes |
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