Back to resultsReal-World Study of Vivity Intraocular Lenses (IOLs)
Primary Purpose
Aphakia, Presbyopia
Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AcrySof IQ Vivity Extended Vision 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 understand and sign an approved informed consent;
- Willing and able to attend all scheduled study visits as required per protocol;
- Diagnosed with cataracts in both eyes;
- Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
- Planned bilateral cataract removal by phacoemulsification.
- 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 surgery history;
- 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 can only undergo cataract surgery in one eye.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Hainan Bo'ao Super Hospital Co., Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vivity IOL
Arm Description
AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Outcomes
Primary Outcome Measures
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
.
Incidence of ocular adverse events
Ocular adverse events will be reported.
Incidence of secondary surgical interventions (SSIs)
Secondary surgical interventions will be reported.
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
Subjects will be surveyed using the QUVID questionnaire.
Secondary Outcome Measures
Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye
Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04800016
Brief Title
Real-World Study of Vivity Intraocular Lenses (IOLs)
Official Title
Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Management decision. No patients enrolled
Study Start Date
June 2021 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
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
No
5. Study Description
Brief Summary
The primary objective of this clinical study is to assess the clinical performance of the AcrySof IQ Vivity Extended Vision IOL in a Chinese population.
Detailed Description
In this clinical study, subjects will be implanted with the AcrySof IQ Vivity Extended Vision 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 13 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
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vivity IOL
Arm Type
Experimental
Arm Description
AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Intervention Type
Device
Intervention Name(s)
AcrySof IQ Vivity Extended Vision IOL
Other Intervention Name(s)
Model DFT015
Intervention Description
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
Intervention Type
Procedure
Intervention Name(s)
Cataract surgery
Intervention Description
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
Primary Outcome Measure Information:
Title
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
Description
Intermediate visual acuity will be assessed at 66 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
Time Frame
Month 6 post second eye implantation
Title
Mean Monocular Distance Corrected Near Visual Acuity (DCNVA) - First Eye
Description
Near visual acuity will be assessed at 40 centimeters (cm) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
.
Time Frame
Month 6 post second eye implantation
Title
Incidence of ocular adverse events
Description
Ocular adverse events will be reported.
Time Frame
Up to Month 12 post second eye implantation
Title
Incidence of secondary surgical interventions (SSIs)
Description
Secondary surgical interventions will be reported.
Time Frame
Up to Month 12 post second eye implantation
Title
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
Description
Subjects will be surveyed using the QUVID questionnaire.
Time Frame
Up to Month 12 post second eye implantation
Secondary Outcome Measure Information:
Title
Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye
Description
Distance visual acuity will be assessed at 4 meters (m) with best correction of distance visual acuity in place. This endpoint is pre-specified for the first implanted eye.
Time Frame
Month 6 post second eye implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Able to understand and sign an approved informed consent;
Willing and able to attend all scheduled study visits as required per protocol;
Diagnosed with cataracts in both eyes;
Pre-operative regular corneal astigmatism less than 1.0 diopter (D);
Planned bilateral cataract removal by phacoemulsification.
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 surgery history;
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 can only undergo cataract surgery in one eye.
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Surgical
Organizational Affiliation
Alcon (China) Ophthalmic Product Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Hainan Bo'ao Super Hospital Co., Ltd.
City
Qionghai
State/Province
Hainan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Real-World Study of Vivity Intraocular Lenses (IOLs)
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