Aphakia Clinical Trial
Official title:
A Prospective, Randomized, Controlled, Multi-Center Clinical Investigation of the AcrySof IQ Vivity Extended Vision IOL vs. TECNIS Symfony and AT LARA Extended Depth of Focus IOLs
Verified date | May 2022 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the visual disturbance profile of an intraocular lens (IOL) using nondiffractive optics, the VIVITY IOL, to two diffractive IOLs in subjects requiring bilateral cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the cataract patient.
Status | Completed |
Enrollment | 222 |
Est. completion date | July 22, 2021 |
Est. primary completion date | May 3, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Planned cataract removal in both eyes. - Willing and able to complete all required postoperative visits. - Able to understand, read and write English and willing to sign an approved statement of informed consent. - Other protocol-defined inclusion criteria may apply. Exclusion Criteria: - Women of childbearing potential, pregnant, intend to become pregnant, breastfeeding. - Any eye condition, disease or pathology, other than cataract, that is expected to reduce postoperative best corrected distance visual acuity, as specified in the protocol. - Ocular trauma or ocular surface disease that would affect study measurements. - Patients who desire monovision correction. - Other protocol-specified exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Alcon Investigator 8047 | Charlestown | New South Wales |
Australia | Alcon Investigator 8052 | Eastwood | South Australia |
Australia | Alcon Investigator 8010 | Essendon | Victoria |
Australia | Alcon Investigator 7813 | Footscray | Victoria |
Australia | Alcon Investigator 7130 | Hobart | Tasmania |
Australia | Alcon Investigator 1702 | Mornington | Victoria |
Australia | Alcon Investigator 8051 | Murdoch | Western Australia |
Australia | Alcon Investigator 6667 | Sydney | New South Wales |
Australia | Alcon Investigator 7678 | Sydney | New South Wales |
New Zealand | Alcon Investigator 8050 | Auckland | |
New Zealand | Alcon Investigator 8056 | Auckland | |
New Zealand | Alcon Investigator 3656 | Wellington |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3) | QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) | |
Secondary | Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3) | Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) | |
Secondary | Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3) | A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100. | Month 3 postoperative (Day 120-180 from second eye surgery) |
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