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Completed

NCT Number: NCT04755231

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

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

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Key information

Conditions

Aphakia Cataract Eye Diseases Lens Diseases Presbyopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital Capital Medical University, Beijing, China

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About this study

In this clinical study, subjects will be implanted with the PanOptix 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 14 months. This study will be conducted in China.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • 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.
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

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.

Other names: Model TFNT00

cataract surgery

Procedure

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

Primary outcomes

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

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

    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.

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

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

    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.

  3. Mean Best Corrected Distance Visual Acuity (BCDVA) - Monocular

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

    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.

  4. Mean Best Corrected Distance Visual Acuity (BCDVA) - Binocular

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

    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.

  5. Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Monocular

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

    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.

  6. Mean Distance Corrected Intermediate Visual Acuity (DCIVA) - Binocular

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

    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.

  7. Mean Distance Corrected Near Visual Acuity (DCNVA) - Monocular

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

    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.

  8. Mean Distance Corrected Near Visual Acuity (DCNVA) - Binocular

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

    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.

  9. Number of Ocular Treatment Emergent Adverse Events

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

    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.

  10. Number of Non-Ocular Treatment Emergent Adverse Events

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

    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.

  11. Number of Secondary Surgical Interventions

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

    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.

  12. Number of Participants Reporting a Severe Visual Disturbance (QUVID)

    Time frame: 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)

    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.

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

    Time frame: 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)

    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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 16, 2021
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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