Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

Clinical Investigation of the Clareon® IOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170154
• Other study ID #: ILJ466-C001
• Status: Completed
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2020
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Clareon aspheric hydrophobic acrylic monofocal IOL
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.

Locations

Country	Name	City	State
United States	Alcon Investigative Site	Appleton	Wisconsin
United States	Alcon Investigative Site	Austin	Texas
United States	Alcon Investigative Site	Bloomfield Hills	Michigan
United States	Alcon Investigative Site	Deerfield Beach	Florida
United States	Alcon Investigative Site	Elizabeth City	North Carolina
United States	Alcon Investigative Site	Florence	South Carolina
United States	Alcon Investigative Site	Fresno	California
United States	Alcon Investigative Site	Kansas City	Missouri
United States	Alcon Investigative Site	Ladson	South Carolina
United States	Alcon Investigative Site	Nacogdoches	Texas
United States	Alcon Investigative Site	New York	New York
United States	Alcon Investigative Site	Orland Park	Illinois
United States	Alcon Investigative Site	Poughkeepsie	New York
United States	Alcon Investigative Site	Sacramento	California
United States	Alcon Investigative Site	San Leandro	California
United States	Alcon Investigative Site	Southern Pines	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at 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.	Month 12 (postoperative)
Primary	Percentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at 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.	Month 12 (postoperative)
Primary	Percentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye	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.	Day 0 (operative), up to Month 12 (postoperative)
Secondary	Mean Absolute IOL Rotation	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.	Day 0 (operative), Month 6 (postoperative)
Secondary	Mean Absolute IOL Misplacement	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.	Day 0 (operative)
Secondary	Mean Absolute IOL Misalignment	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.	Day 0 (operative), Month 6 (postoperative)