An interventional study of AcrySof IQ Vivity Extended Vision IOL and Cataract surgery in Aphakia and Presbyopia, sponsored by Alcon Research. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Alcon Research (part of Alcon) · Not applicable, Interventional, and Treatment
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.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
Browse Aphakia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AcrySof IQ Vivity Extended Vision IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery
Device: AcrySof IQ Vivity Extended Vision IOL · Procedure: Cataract surgery
UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
Also known as: Model DFT015
Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
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.
Time frame: 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. .
Time frame: Month 6 post second eye implantation
Incidence of ocular adverse events
Ocular adverse events will be reported.
Time frame: Up to Month 12 post second eye implantation
Incidence of secondary surgical interventions (SSIs)
Secondary surgical interventions will be reported.
Time frame: 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.
Time frame: Up to Month 12 post second eye implantation
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.
Time frame: Month 6 post second eye implantation
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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