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Completed

NCT Number: NCT03090256

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL

The purpose of this study is to evaluate the effectiveness and safety of the AcrySof® IQ PanOptix™ Intraocular Lens (IOL) Model TFNT00 when implanted to replace the natural lens following cataract removal.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Fukuoka, Japan

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About this study

Eligible subjects will attend a total of 10 visits over a 7-month period. Subjects will complete a preoperative examination of both eyes (Visit 0), followed by implantation of the IOL at the operative visit for each eye (Visit 00/00A), and up to 7 postoperative visits (each eye examined at Day 1-2 (Visit 1/1A), Day 7-14 (Visit 2/2A), and Day 30-60 (Visit 3/3A), with a binocular visit at Day 120-180 (Visit 4A) after the second implantation. The second implantation will occur within 30 days of the first.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to comprehend and sign a statement of informed consent;
  • Willing and able to complete all required postoperative visits;
  • Cataracts in both eyes with planned cataract removal by phacoemulsification;
  • Calculated lens power within the available range;
  • Potential postoperative best corrected distance visual acuity (BCDVA) of 0.5 decimal or better in both eyes;
  • Able to undergo second eye surgery within 30 days of the first eye surgery.

Exclusion criteria

  • Significant irregular corneal aberration as demonstrated by corneal topography;
  • Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
  • Degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future acuity losses;
  • Previous refractive surgery;
  • Diabetic retinopathy
  • Other eye conditions as specified in the protocol
  • Pregnant.

Treatment and study plan

AcrySof® IQ PanOptix™ IOL

Device

Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient

Other names: Model TFNT00

Primary outcomes

  1. Monocular Photopic Best Corrected Distance Visual Acuity (5 m)

    Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

    Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

  2. Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)

    Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

  3. Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)

    Time frame: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation

    VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2017
Registry last updated
Sep 24, 2019

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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