NCT03316885

Brief Summary

The primary purpose of this study is to evaluate the long-term (3 years) visual acuity and adverse event outcomes for the Clareon® Intraocular Lens (IOL). A comparison to historical safety and performance endpoint (SPE) rates as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014 will be conducted at one year. The secondary purpose of this study is to evaluate the visual acuity outcomes with the Clareon IOL at Years 2 and 3.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
7 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

October 18, 2017

Results QC Date

September 20, 2022

Last Update Submit

August 17, 2023

Conditions

CataractAphakia

Outcome Measures

Primary Outcomes (2)

  • Percentage of First Implanted Eyes Achieving Best-Corrected Distance Visual Acuity (BCDVA) of 0.3 Logarithm Minimum Angle of Resolution (logMAR) or Better at 1 Year Post-Implantation

    Visual acuity (VA) was tested for the first implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. VA was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical safety and performance endpoint (SPE) of 92.5% \[as reported in the European Standard International Organization for Standardization (EN ISO) 11979-7:2014\].

    Year 1 post-implantation from second eye surgery

  • Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 1 Year Post-Implantation

    VA was tested for the second implanted eye using the correction obtained from the manifest refraction and 100% contrast electronic ETDRS charts at a distance of 4 m from the eye. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter on an ETDRS chart. A BCDVA of 0.3 logMAR is equivalent to 20/40 Snellen visual acuity. VA was compared to the historical SPE of 92.5% (EN ISO 11979-7:2014).

    Year 1 post-implantation from second eye surgery

Secondary Outcomes (10)

  • Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation

    Year 2 post-implantation from second eye surgery

  • Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 2 Years Post-Implantation

    Year 2 post-implantation from second eye surgery

  • Percentage of First Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation

    Year 3 post-implantation from second eye surgery

  • Percentage of Second Implanted Eyes Achieving BCDVA of 0.3 logMAR or Better at 3 Years Post-Implantation

    Year 3 post-implantation from second eye surgery

  • Uncorrected Distance Visual Acuity (UCDVA) at 1 Year Post-Implantation - First Implanted Eye

    Year 1 post-implantation from second eye surgery

  • +5 more secondary outcomes

Study Arms (1)

Clareon IOL

EXPERIMENTAL

Clareon® aspheric hydrophobic acrylic intraocular lens implanted with the Alcon Monarch III-D delivery system as a replacement of the human crystalline lens during cataract surgery

Device: Clareon® IOLProcedure: Cataract Surgery

Interventions

Clareon® IOLDEVICE

Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.

Also known as: Model SY60WF
Clareon IOL
Cataract SurgeryPROCEDURE

Routine small incision cataract surgery with unilateral IOL implantation

Clareon IOL

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with bilateral cataracts
  • Planned small incision cataract removal surgery
  • Able to comprehend and willing to sign a statement of informed consent and complete all required post-implantation visits

You may not qualify if:

  • Subjects who may reasonably be expected to require ocular surgical treatment or refractive surgical procedures at any time during the study
  • Certain eye conditions, as specified in the protocol, including but not limited to glaucoma, diabetic retinopathy, diabetic macular edema, and macular degeneration
  • Pregnant or lactating, current or planned during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Alcon Investigative Site

Footscray, Victoria, 3011, Australia

Location

Alcon Investigative Site

Mornington, Victoria, 3931, Australia

Location

Alcon Investigative Site

Sydney, 2067, Australia

Location

Alcon Investigative Site

Brest, Cedex, 29609, France

Location

Alcon Investigative Site

Lyon, 69003, France

Location

Alcon Investigative Site

Paris, 75014, France

Location

Alcon Investigative Site

Frankfurt, 60590, Germany

Location

Alcon Investigative Site

Heidelberg, 69120, Germany

Location

Alcon Investigative Site

Perugia, 06129, Italy

Location

Alcon Investigative Site

Pisa, 56124, Italy

Location

Alcon Investigative Site

Amsterdam, 1105AZ, Netherlands

Location

Alcon Investigative Site

Jerez de la Frontera, Cadiz, 11408, Spain

Location

Alcon Investigative Site

Alcalá de Henares, 28805, Spain

Location

Alcon Investigative Site

Oviedo, 33012, Spain

Location

Alcon Investigative Site

San Sebastián, 20014, Spain

Location

Alcon Investigative Site

Valencia, 46015, Spain

Location

Alcon Investigative Site

Sutton, Carshalton, SM5 1AA, United Kingdom

Location

Alcon Investigative Site

Brighton, BN2 5BF, United Kingdom

Location

Alcon Investigative Site

London, EC1V2PD, United Kingdom

Location

MeSH Terms

Conditions

CataractAphakia

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Director, Clinical Projects - CDMA Surgical
Organization
Alcon Research, LLC
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Trial Lead, CDMA, Surgical

    Alcon Research, LLC

    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

October 18, 2017

First Posted

October 20, 2017

Study Start

March 14, 2018

Primary Completion

October 18, 2019

Study Completion

September 23, 2021

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)IT(2)DE(2)NL(1)AU(3)GB(3)ES(5)