AphakiaNCT04800016
Real-World Study of Vivity Intraocular Lenses (IOLs)
A study testing AcrySof IQ Vivity Extended Vision IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphakia, Presbyopia
- What is being tested?
- AcrySof IQ Vivity Extended Vision IOL and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jun 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Other planned ocular surgical procedures;
- Patients who can only undergo cataract surgery in one eye.
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
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.
Read the 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.
- Conditions
- Aphakia, Presbyopia
- Being tested
- AcrySof IQ Vivity Extended Vision IOL, Cataract surgery
- Keywords
- Cataract, Intraocular lens
- Medical subject headings
- Aphakia, Presbyopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcrySof IQ Vivity Extended Vision IOLDevice
Also called Model DFT015
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
Cataract surgeryProcedure or surgery
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
| Study group | Role | What they receive |
|---|---|---|
| Vivity IOL | Experimental | AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery Receives: Device: AcrySof IQ Vivity Extended Vision IOL; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6 post second eye implantation
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.
.
Measured: Month 6 post second eye implantation
Incidence of ocular adverse events
Ocular adverse events will be reported.
Measured: Up to Month 12 post second eye implantation
Incidence of secondary surgical interventions (SSIs)
Secondary surgical interventions will be reported.
Measured: Up to Month 12 post second eye implantation
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
Subjects will be surveyed using the QUVID questionnaire.
Measured: Up to Month 12 post second eye implantation
Secondary outcomes (1)
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.
Measured: Month 6 post second eye implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Management decision. No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Surgical, Study director, Alcon (China) Ophthalmic Product Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800016
- Sponsor's protocol ID
- ILI875-P002
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of AcrySof™ IQ Vivity Extended Vision Intraocular Lenses (IOLs)
- ClinicalTrials.gov ID
- NCT04800016
- Acronym / sponsor ID
- ILI875-P002
- Conditions
- Aphakia, Presbyopia
- Keywords
- Cataract, Intraocular lens
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision. No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivity IOL | Experimental | Device: AcrySof IQ Vivity Extended Vision IOL, Procedure: Cataract surgeryAcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcrySof IQ Vivity Extended Vision IOLAlso: Model DFT015UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near. | Device | Vivity IOL |
| Cataract surgeryCataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL | Procedure or surgery | Vivity IOL |
Primary outcome
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye
Time frame: Month 6 post second eye implantation
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
Time frame: Month 6 post second eye implantation
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
Time frame: Up to Month 12 post second eye implantation
Ocular adverse events will be reported.
Incidence of secondary surgical interventions (SSIs)
Time frame: Up to Month 12 post second eye implantation
Secondary surgical interventions will be reported.
Incidence of severe or most bothersome visual disturbances (subjects surveyed with QUVID questionnaire)
Time frame: Up to Month 12 post second eye implantation
Subjects will be surveyed using the QUVID questionnaire.
1 secondary outcome
Percentage of Eyes Achieving 0.2 logMAR or better Best Corrected Distance Visual Acuity (BCDVA) - First Eye
Time frame: Month 6 post second eye implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Lead, Surgical study director
Alcon (China) Ophthalmic Product Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AcrySof IQ Vivity Extended Vision IOL and Cataract surgery in people with Aphakia and Presbyopia, run by Alcon Research at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) - First Eye (time frame: Month 6 post second eye implantation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.