Post-Market Clinical Study of the PanOptix Intraocular Lens (IOL) in a Chinese Population

NCT04755231 | Completed Results DMC FDA Device

• 1 other identifier: ILH297-C004
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 9

Brief Summary

The primary objective of this clinical study is to assess the clinical performance of the PanOptix IOL in a Chinese population.

Conditions

Aphakia; Presbyopia

Keywords

Cataract; Intraocular Lens

Outcome Measures

Primary Outcomes (13)

• Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Monocular

  Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) Equal to or Better Than 0.3 LogMAR - Binocular

  VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular

  Visual acuity (VA) was assessed monocularly (eyes individually) with best refractive correction in place under photopic (well-lit) conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular

  VA was assessed binocularly (eyes together) with best refractive correction in place under photopic conditions at a distance of 5 meters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular

  VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular

  VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 60 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular

  VA was assessed monocularly (eyes individually) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular

  VA was assessed binocularly (eyes together) with distance correction in place (plus or minus power) under photopic conditions at a distance of 40 centimeters using Chinese Standard Logarithmic VA charts. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery)

• Number of Ocular Treatment Emergent Adverse Events

  An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.

  Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

• Number of Non-Ocular Treatment Emergent Adverse Events

  An adverse event was defined as any adverse medical event that occurred during the clinical trial whether or not it was related to the investigational medical device or test procedure. No hypothesis testing was pre-specified for this endpoint.

  Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

• Number of Secondary Surgical Interventions

  A secondary surgical intervention (SSI) was defined as a surgical procedure occurring after primary implantation of the IOL. Posterior capsulotomies were excluded from the definition of secondary surgical interventions. No hypothesis testing was pre-specified for this endpoint.

  Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

• Number of Participants Reporting a Severe Visual Disturbance (QUVID)

  The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Severe Was Your Worst Experience" and responded on a 5-point scale, where 0-4 scale, where 0=none, 1=a little, 2=mild, 3=moderate, and 4=severe. No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

• Number of Participants Reporting a Most Bothersome Visual Disturbance (QUVID)

  The Questionnaire for Visual Disturbances (QUVID) is a patient-reported outcomes questionnaire that collects responses about 7 vision-related experiences. For each experience, the participant was asked, "In the Past 7 Days, How Much Were You Bothered With" and responded on a 5-point scale, where 0=not bothered at all, 1=bothered a little, 2=bothered somewhat, 3=bothered quite a bit, and 4=bothered very much (most bothersome). No hypothesis testing was pre-specified for this endpoint.

  Month 6 (180-210 days post second eye surgery, 187-238 days post first eye surgery); Month 12 (360-390 days post second eye surgery, 367-418 days post first eye surgery)

Study Arms (1)

PanOptix IOL

EXPERIMENTAL

AcrySof IQ PanOptix Presbyopia Correcting IOL implanted in the capsular bag in the posterior chamber of the eye during cataract surgery

Device: AcrySof IQ PanOptix Presbyopia Correcting IOL; Procedure: Cataract surgery

Interventions

AcrySof IQ PanOptix Presbyopia Correcting IOL DEVICE

UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.

Also known as: Model TFNT00

PanOptix IOL

Cataract surgery PROCEDURE

Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL

PanOptix 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 comprehend and sign an informed consent form;
• Able to complete all study visits required in the protocol;
• Chinese; diagnosed with cataracts in both eyes;
• Planned bilateral cataract removal by routine phacoemulsification;
• Pre-operative regular corneal astigmatism of less than 1.0 diopter (D);
• Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal to 0.3 LogMAR in each eye;
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 logMAR or better in both eyes based on the investigator expert medical opinion.

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 or corneal surgery;
• 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 desire monovision correction.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (9)

Peking University People's Hospital

Beijing, 100044, China

Location

Beijing Tongren Hospital Capital Medical University

Beijing, 100730, China

Location

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guandong, 510060, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, 310009, China

Location

Ophthalmic Hospital Affiliated to Shandong University of Traditional Chinese Medicine

Shandong, 250002, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, 200031, China

Location

Shanxi Eye Hospital

Shanxi, 710068, China

Location

West China Hospital of Sichuan University

Sichuan, 610041, China

Location

Tianjin Medical University Eye Hospital

Tianjin, 300384, 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

Results Point of Contact

• Title: Director, Clinical Projects, Surgical
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Project Manager, Surgical

  Alcon (China) Ophthalmic Product Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 11, 2021
• First Posted: February 16, 2021
• Study Start: April 19, 2021
• Primary Completion: August 31, 2022
• Study Completion: March 15, 2023
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)