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The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
In this clinical study, subjects will be implanted with the PanOptix IOL in both eyes. The second eye surgery will occur 7-28 days after the first eye. A total of 11 scheduled visits are planned, including a screening visit, two operative visits, and 8 postoperative visits. The total expected duration of the subject's participation will be about 14 months. This study will be conducted in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PanOptix IOL | Experimental | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof IQ PanOptix Presbyopia Correcting IOL | Device | UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular | VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular | VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Project Manager, Surgical | Alcon (China) Ophthalmic Product Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | China | |||
| Beijing Tongren Hospital Capital Medical University |
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Of the 181 who signed an informed consent document, 37 participants were discontinued prior to implantation: 27 participants were screen failures, and 10 participants withdrew. This reporting group includes all participants with attempted implantation (144).
Participants were recruited from 9 investigative sites located in China.
| ID | Title | Description |
|---|---|---|
| FG000 | PanOptix IOL | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Full Analysis Set: This analysis population includes all subjects who had successful IOL implantation in at least one eye and at least one postoperative effectiveness assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | PanOptix IOL | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
| 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 | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular | Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Number | percentage of eyes | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
Adverse events (AEs) were collected from time of enrollment until study exit, approximately 14 months.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for Pretreatment and Systemic AEs is reported in units of subjects. "At Risk" population for Ocular AEs is reported in units of eyes. This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye).
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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 | Pretreatment | Events reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the second eye prior to implantation, as well as overall systemic events. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Projects, Surgical | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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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 | Nov 5, 2020 | Aug 15, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2021 | Aug 15, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001035 | Aphakia |
| D011305 | Presbyopia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Cataract surgery | Procedure | Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL |
|
| Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular | VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular | VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) |
| Number of Ocular Treatment Emergent Adverse Events | An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint. | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
| Number of Non-Ocular Treatment Emergent Adverse Events | An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint. | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
| Number of Secondary Surgical Interventions | A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint. | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
| Number of Participants Reporting a Severe Visual Disturbance (QUVID) | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
| Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint. | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
| Beijing |
| 100730 |
| China |
| Zhongshan Ophthalmic Center, Sun Yat-Sen University | Guandong | 510060 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | 310009 | China |
| Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine | Shandong | 250002 | China |
| Eye & ENT Hospital of Fudan University | Shanghai | 200031 | China |
| Shanxi Eye Hospital | Shanxi | 710068 | China |
| West China Hospital of Sichuan University | Sichuan | 610041 | China |
| Tianjin Medical University Eye Hospital | Tianjin | 300384 | China |
| years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | PanOptix IOL - Second Eye | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
| OG002 | PanOptix IOL - All Eyes | AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
|
|
| Primary | Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular | VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Number | percentage of participants | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
|
| Primary | Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular | Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
|
| Primary | Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular | VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
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| Primary | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular | VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
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| Primary | Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular | VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
|
| Primary | Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular | VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
|
| Primary | Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular | VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint. | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | logMAR | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery) | eyes | eyes |
|
|
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| Primary | Number of Ocular Treatment Emergent Adverse Events | An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). | Posted | Number | adverse events | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) | eyes | eyes |
|
|
|
| Primary | Number of Non-Ocular Treatment Emergent Adverse Events | An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). | Posted | Number | adverse events | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
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| Primary | Number of Secondary Surgical Interventions | A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set: All subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). | Posted | Number | secondary surgical interventions | Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) | eyes | eyes |
|
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| Primary | Number of Participants Reporting a Severe Visual Disturbance (QUVID) | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set with data at visit | Posted | Number | participants | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
|
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| Primary | Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID) | The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint. | Safety Analysis Set with data at visit | Posted | Number | participants | Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery) |
|
|
|
| 0 |
| 144 |
| 0 |
| 144 |
| 2 |
| 144 |
| EG001 | PanOptix IOL Ocular - First Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the first implanted eye | 0 | 144 | 2 | 144 | 15 | 144 |
| EG002 | PanOptix IOL Ocular - Second Eye | Events reported in this group occurred after attempted implantation with the test article and include ocular events in the second implanted eye | 0 | 142 | 3 | 142 | 11 | 142 |
| EG003 | PanOptix IOL Systemic | Events reported in this group occurred after attempted implantation with the test article | 0 | 144 | 6 | 144 | 0 | 144 |
| Deafness | Ear and labyrinth disorders | MedDRA 23.1 | Systematic Assessment |
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| Cystoid macular oedema | Eye disorders | MedDRA 23.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Halos |
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| Glare |
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| Hazy Vision |
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| Blurred Vision |
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| Double Vision |
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| Dark Area |
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| Halos |
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| Glare |
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| Hazy Vision |
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| Blurred Vision |
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| Double Vision |
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| Dark Area |
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