Back to resultsPost-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Primary Purpose
Aphakia, Presbyopia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AcrySof IQ PanOptix Presbyopia Correcting IOL
Cataract surgery
Sponsored by
About this trial
This is an interventional treatment trial for Aphakia focused on measuring Cataract, Intraocular Lens
Eligibility Criteria
Key Inclusion Criteria:
- Able to comprehend and sign an informed consent form;
- Able to complete all study visits required in the protocol;
- Chinese; diagnosed with cataracts in both eyes;
- Planned bilateral cataract removal by routine phacoemulsification;
- Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
- Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
- Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
- Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
- Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
- Clinically significant corneal diseases;
- Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
- Previous intraocular or corneal surgery;
- Pregnancy or lactation during study or planning to be pregnant/lactating;
- Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
- Other planned ocular surgical procedures;
- Patients who desire monovision.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Beijing Tongren Hospital Capital Medical University
- Zhongshan Ophthalmic Center, Sun Yat-Sen University
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Peking University People's Hospital
- Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
- Eye & ENT Hospital of Fudan University
- Shanxi Eye Hospital
- West China Hospital of Sichuan University
- Tianjin Medical University Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PanOptix IOL
Arm Description
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04755231
Brief Title
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
Official Title
Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
March 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Presbyopia
Keywords
Cataract, Intraocular Lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
181 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PanOptix IOL
Arm Type
Experimental
Arm Description
AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Intervention Type
Device
Intervention Name(s)
AcrySof IQ PanOptix Presbyopia Correcting IOL
Other Intervention Name(s)
Model TFNT00
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
Primary Outcome Measure Information:
Title
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular
Description
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.
Time Frame
Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)
Title
Number of Ocular Treatment Emergent Adverse Events
Description
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.
Time Frame
Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Title
Number of Non-Ocular Treatment Emergent Adverse Events
Description
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.
Time Frame
Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Title
Number of Secondary Surgical Interventions
Description
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.
Time Frame
Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)
Title
Number of Participants Reporting a Severe Visual Disturbance (QUVID)
Description
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.
Time Frame
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)
Title
Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)
Description
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.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to comprehend and sign an informed consent form;
Able to complete all study visits required in the protocol;
Chinese; diagnosed with cataracts in both eyes;
Planned bilateral cataract removal by routine phacoemulsification;
Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.
Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
Glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic changes associated with the optic nerve;
Clinically significant corneal diseases;
Clinically significant/severe dry eye that would affect study measurements based on the investigator's expert medical opinion;
Previous intraocular or corneal surgery;
Pregnancy or lactation during study or planning to be pregnant/lactating;
Systemic medications that, in the opinion of the Investigator, may confound the outcome or increase the risk to the subject;
Other planned ocular surgical procedures;
Patients who desire monovision correction.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Project Manager, Surgical
Organizational Affiliation
Alcon (China) Ophthalmic Product Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Tongren Hospital Capital Medical University
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-Sen University
City
Guandong
ZIP/Postal Code
510060
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Peking University People's Hospital
City
Peking
ZIP/Postal Code
100044
Country
China
Facility Name
Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine
City
Shandong
ZIP/Postal Code
250002
Country
China
Facility Name
Eye & ENT Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
200031
Country
China
Facility Name
Shanxi Eye Hospital
City
Shanxi
ZIP/Postal Code
710068
Country
China
Facility Name
West China Hospital of Sichuan University
City
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin
ZIP/Postal Code
300384
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population
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