Real-World Study of Vivity Intraocular Lenses (IOLs)

NCT04800016 | Withdrawn FDA Device

• 1 other identifier: ILI875-P002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aphakia; Presbyopia

Keywords

Cataract; Intraocular lens

Outcome Measures

Primary Outcomes (5)

• 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.

  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. .

  Month 6 post second eye implantation

• Incidence of ocular adverse events

  Ocular adverse events will be reported.

  Up to Month 12 post second eye implantation

• Incidence of secondary surgical interventions (SSIs)

  Secondary surgical interventions will be reported.

  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.

  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

  Month 6 post second eye implantation

Study Arms (1)

Vivity IOL

EXPERIMENTAL

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

Interventions

AcrySof IQ Vivity Extended Vision IOL DEVICE

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

Vivity IOL

Cataract surgery PROCEDURE

Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL

Vivity IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Hainan Bo'ao Super Hospital Co., Ltd.

Qionghai, Hainan, China

Location

MeSH Terms

Conditions

Aphakia; Presbyopia; Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Clinical Trial Lead, Surgical

  Alcon (China) Ophthalmic Product Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 16, 2021
• Study Start: June 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)