Skip to main content
OpenTrials
Completed

NCT Number: NCT03170154

Clinical Investigation of the Clareon® Intraocular Lens (IOL)

The objective of this study is to compare visual acuity and adverse event outcomes from the Clareon intraocular lens (IOL) to historical safety and performance endpoint (SPE) rates.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alcon Investigative Site, Fresno, California, United States

Loading trial locations.

About this study

Upon meeting eligibility criteria, subjects were implanted unilaterally (in one eye) with a Clareon IOL. Subjects attended 7 study visits over a period of approximately 13 months, including 1 preoperative screening visit (Visit 0), 1 operative visit (Visit 00), and 5 postoperative visits (Visits 1-5). Visit day calculations for Visits 1-5 were based off of the day of surgery (Visit 00). Primary endpoint data was collected at the final visit (Month 12). Some sites/subjects participated in a Rotational Stability sub-study. For the non-study eye, the investigator followed standard of care regarding the follow-up, surgery, and intraocular lens choice (as applicable). The non-study eye (fellow eye) was not implanted with the Clareon IOL.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Planned routine cataract surgery in at least one eye;
  • Calculated lens power within the available range;
  • Willing and able to sign an informed consent statement;
  • Clear intraocular media other than cataract.

Key Exclusion Criteria:

  • Any disease or pathology, other than cataract, that is expected to reduce the potential postoperative best corrected distance visual acuity (BCDVA) to a level worse than 0.30 logMAR;
  • Previous corneal surgery;
  • Rubella or traumatic cataract;
  • Ocular trauma, previous refractive surgery;
  • Current or recent use of certain medications as specified in the protocol;
  • Any other ocular or systemic condition that, in the opinion of the Investigator, should exclude the subject from the study.

Treatment and study plan

Clareon aspheric hydrophobic acrylic monofocal IOL

Device

Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.

Primary outcomes

  1. Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative

    Time frame: Month 12 (postoperative)

    Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic (well-lit) conditions at a distance of 4 meters using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.

  2. Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative

    Time frame: Month 12 (postoperative)

    Visual acuity (VA) of the study eye was assessed with best refractive correction in place under photopic conditions at a distance of 4 meters using an Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. As pre-specified in the protocol, the percentage of subjects with monocular BCDVA of 0.3 logMAR or better at Month 12 was compared to the historical safety and performance endpoint (SPE) rate reported in EN ISO 11979-7:2014. A higher percentage indicates good visual acuity outcomes with most subjects achieving 0.3 logMAR or better.

  3. Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye

    Time frame: Day 0 (operative), up to Month 12 (postoperative)

    Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. No hypothesis testing was pre-specified in the protocol.

Secondary outcomes

  1. Mean Absolute IOL Rotation

    Time frame: Day 0 (operative), Month 6 (postoperative)

    IOL rotation was defined as the difference between axis of IOL orientation on the day of surgery and Month 6. IOL rotation and measured with slit-lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL rotation at 6 months.

  2. Mean Absolute IOL Misplacement

    Time frame: Day 0 (operative)

    IOL misplacement was defined as the difference between intended axis of placement and actual axis of IOL orientation on day of surgery. IOL misplacement was measured using slit lamp photography. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misplacement.

  3. Mean Absolute IOL Misalignment

    Time frame: Day 0 (operative), Month 6 (postoperative)

    IOL misalignment was defined as the summation of IOL misplacement and IOL rotation at Month 6. No hypothesis testing was pre-specified in the protocol. A lower number indicates minimal IOL misalignment at 6 months.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Clinical Investigation of the Clareon® IOL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Aug 3, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.