Clinical Investigation of the Clareon® Intraocular Lens (IOL)

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03170154
Collaborator
(none)
376
Enrollment
16
Locations
1
Arm
18.7
Actual Duration (Months)
23.5
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Clareon aspheric hydrophobic acrylic monofocal IOL
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
376 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of the Clareon® IOL
Actual Study Start Date :
Jul 25, 2017
Actual Primary Completion Date :
Feb 15, 2019
Actual Study Completion Date :
Feb 15, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: Clareon IOL

Clareon aspheric hydrophobic acrylic monofocal IOL implanted in one eye during routine small incision cataract surgery

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.

Outcome Measures

Primary Outcome Measures

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

  1. Mean Absolute IOL Rotation [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Investigative SiteFresnoCaliforniaUnited States93720
2Alcon Investigative SiteSacramentoCaliforniaUnited States95815
3Alcon Investigative SiteSan LeandroCaliforniaUnited States94578
4Alcon Investigative SiteDeerfield BeachFloridaUnited States33064
5Alcon Investigative SiteOrland ParkIllinoisUnited States60467
6Alcon Investigative SiteBloomfield HillsMichiganUnited States48302
7Alcon Investigative SiteKansas CityMissouriUnited States64154
8Alcon Investigative SiteNew YorkNew YorkUnited States10013
9Alcon Investigative SitePoughkeepsieNew YorkUnited States12603
10Alcon Investigative SiteElizabeth CityNorth CarolinaUnited States27909
11Alcon Investigative SiteSouthern PinesNorth CarolinaUnited States28387
12Alcon Investigative SiteFlorenceSouth CarolinaUnited States29501
13Alcon Investigative SiteLadsonSouth CarolinaUnited States29456
14Alcon Investigative SiteAustinTexasUnited States78731
15Alcon Investigative SiteNacogdochesTexasUnited States75965
16Alcon Investigative SiteAppletonWisconsinUnited States54914

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03170154
Other Study ID Numbers:
  • ILJ466-C001
First Posted:
May 30, 2017
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects were recruited at 16 investigative sites located in the United States.
Pre-assignment DetailOf the 376 enrolled, 26 subjects did exit the study as screen failures. This reporting group (350) includes all subjects with attempted implantation with the IOL (successful or aborted after contact with the eye).
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Period Title: Overall Study
STARTED350
Rotational Stability Sub-study141
COMPLETED342
NOT COMPLETED8

Baseline Characteristics

Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Overall Participants350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.7
(6.44)
Sex: Female, Male (Count of Participants)
Female
213
60.9%
Male
137
39.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
11
3.1%
Not Hispanic or Latino
336
96%
Unknown or Not Reported
3
0.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
29
8.3%
Native Hawaiian or Other Pacific Islander
1
0.3%
Black or African American
36
10.3%
White
273
78%
More than one race
0
0%
Unknown or Not Reported
11
3.1%
Region of Enrollment (participants) [Number]
United States
350
100%

Outcome Measures

1. Primary Outcome
TitlePercentage of All-implanted Subjects Achieving Monocular Best Corrected Distance Visual Acuity (BCDVA) of 0.3 logMAR or Better at Month 12 Postoperative
DescriptionVisual 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.
Time FrameMonth 12 (postoperative)

Outcome Measure Data

Analysis Population Description
All-Implanted Subjects (AAS): All subjects/eyes with successful IOL implantation and data at visit
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Measure Participants342
Measure eyes342
Number (95% Confidence Interval) [percentage of subjects]
99.7
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clareon IOL
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation Parameter1-sided 95% Upper CL
Estimated Value99.99
Confidence Interval (1-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation CommentsHistorical comparison to EN ISO 11979-7:2014: SPE rate of at least 92.5 for the AAS at 12 months.
2. Primary Outcome
TitlePercentage of Best-case Subjects Achieving Monocular BCDVA of 0.3 logMAR or Better at Month 12 Postoperative
DescriptionVisual 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.
Time FrameMonth 12 (postoperative)

Outcome Measure Data

Analysis Population Description
Best-Case Analysis Set (BAS): All subjects/eyes successfully implanted with the IOL that had at least 1 postoperative visit, no preoperative ocular pathology, no macular degeneration at any time, and no previous surgery for the correction of refractive errors, with data at visit.
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Measure Participants326
Measure eyes326
Number (95% Confidence Interval) [percentage of subjects]
99.7
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clareon IOL
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation Parameter1-sided 95% Upper CL
Estimated Value99.98
Confidence Interval (1-Sided) 95%
to
Parameter Dispersion Type:
Value:
Estimation CommentsHistorical comparison to EN ISO 11979-7:2014: SPE rate of at least 96.7 for the BAS at 12 months.
3. Primary Outcome
TitlePercentage of Subjects With Adverse Events (Ocular and Nonocular, Serious and Nonserious), Including Secondary Surgical Interventions (SSIs) - Study Eye
DescriptionAdverse 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.
Time FrameDay 0 (operative), up to Month 12 (postoperative)

Outcome Measure Data

Analysis Population Description
Safety Analysis Set (SAS): All subjects/study eyes with attempted implantation with the test article (successful or aborted after contact with the eye)
Arm/Group TitlePre-treatmentClareon IOL - OcularSystemic
Arm/Group DescriptionEvents reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye, as well as overall systemic events.Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.Events reported in this group occurred after attempted implantation with the test article.
Measure Participants350350350
Serious Adverse Events
0
2.3
4.0
Non-Serious Adverse Events
1.4
27.1
15.1
4. Secondary Outcome
TitleMean Absolute IOL Rotation
DescriptionIOL 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.
Time FrameDay 0 (operative), Month 6 (postoperative)

Outcome Measure Data

Analysis Population Description
Rotation Analysis Set (RAS): All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit and Month 6 visit.
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Measure Participants124
Measure eyes124
Mean (Standard Deviation) [degrees]
2.2696
(3.87231)
5. Secondary Outcome
TitleMean Absolute IOL Misplacement
DescriptionIOL 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.
Time FrameDay 0 (operative)

Outcome Measure Data

Analysis Population Description
RAS: All subjects/eyes with successful IOL implantation from the rotational subset of 6 clinical sites, with rotation data available at operative visit.
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Measure Participants131
Measure eyes131
Mean (Standard Deviation) [degrees]
5.1163
(4.90305)
6. Secondary Outcome
TitleMean Absolute IOL Misalignment
DescriptionIOL 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.
Time FrameDay 0 (operative), Month 6 (postoperative)

Outcome Measure Data

Analysis Population Description
RAS, with rotation data available at operative visit and Month 6 visit
Arm/Group TitleClareon IOL
Arm/Group DescriptionClareon aspheric hydrophobic acrylic monofocal intraocular lens (IOL) implanted in one eye during routine small incision cataract surgery
Measure Participants124
Measure eyes124
Mean (Standard Deviation) [degrees]
5.6762
(6.42510)

Adverse Events

Time FrameAdverse events were collected pre-treatment (Day -30 to 0) up to Month 12 post-treatment/study exit. Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
Adverse Event Reporting Description This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes. For the non-study eye (fellow eye), the investigator followed standard of care regarding the follow-up, surgery, and IOL choice (as applicable). The non-study eye was not implanted with Clareon IOL.
Arm/Group TitlePre-treatmentClareon IOL - Ocular (Study Eye)Systemic and Ocular Non-Study (Non-Clareon) Eye
Arm/Group DescriptionEvents reported in this group occurred prior to attempted implantation with the test article and may include ocular events in the study eye and non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye.Events reported in this group occurred after attempted implantation with the test article and may include ocular events in the non-study eye (fellow eye), as well as overall systemic events. The non-study eye was not implanted with Clareon IOL.
All Cause Mortality
Pre-treatmentClareon IOL - Ocular (Study Eye)Systemic and Ocular Non-Study (Non-Clareon) Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/350 (0%) 0/350 (0%) 2/350 (0.6%)
Serious Adverse Events
Pre-treatmentClareon IOL - Ocular (Study Eye)Systemic and Ocular Non-Study (Non-Clareon) Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/350 (0%) 8/350 (2.3%) 18/350 (5.1%)
Blood and lymphatic system disorders
Lymphadenopathy0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Cardiac disorders
Acute myocardial infarction0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Atrial fibrillation0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Myocardial infarction0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Eye disorders
Cystoid macular oedema0/350 (0%) 03/350 (0.9%) 31/350 (0.3%) 1
Macular fibrosis0/350 (0%) 01/350 (0.3%) 10/350 (0%) 0
Macular hole0/350 (0%) 01/350 (0.3%) 10/350 (0%) 0
Punctate keratitis0/350 (0%) 01/350 (0.3%) 12/350 (0.6%) 2
Retinal tear0/350 (0%) 02/350 (0.6%) 21/350 (0.3%) 1
Gastrointestinal disorders
Dysphagia0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
General disorders
Death0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Hepatobiliary disorders
Cholelithiasis0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Infections and infestations
Herpes virus infection0/350 (0%) 01/350 (0.3%) 10/350 (0%) 0
Pneumonia0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Septic shock0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Injury, poisoning and procedural complications
Subdural haematoma0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Traumatic intracranial haemorrhage0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Breast cancer0/350 (0%) 00/350 (0%) 02/350 (0.6%) 2
Nervous system disorders
Cerebral artery embolism0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Cerebral haematoma0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Hemiplegia0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Surgical and medical procedures
Corneal operation0/350 (0%) 01/350 (0.3%) 22/350 (0.6%) 2
Hip arthroplasty0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Ophthalmologic treatment0/350 (0%) 01/350 (0.3%) 10/350 (0%) 0
Radical hysterectomy0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Retinal laser coagulation0/350 (0%) 02/350 (0.6%) 20/350 (0%) 0
Retinopexy0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Urostomy0/350 (0%) 00/350 (0%) 01/350 (0.3%) 1
Vitrectomy0/350 (0%) 02/350 (0.6%) 20/350 (0%) 0
Other (Not Including Serious) Adverse Events
Pre-treatmentClareon IOL - Ocular (Study Eye)Systemic and Ocular Non-Study (Non-Clareon) Eye
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total6/350 (1.7%) 19/350 (5.4%) 127/350 (36.3%)
Eye disorders
Posterior capsule opacification0/350 (0%) 019/350 (5.4%) 1918/350 (5.1%) 18
Surgical and medical procedures
Cataract operation6/350 (1.7%) 60/350 (0%) 0117/350 (33.4%) 117

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

Name/TitleSr. Clinical Trial Lead, CDMA Surgical
OrganizationAlcon Research, LLC
Phone1-888-451-3937
Emailalcon.medinfo@alcon.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03170154
Other Study ID Numbers:
  • ILJ466-C001
First Posted:
May 30, 2017
Last Update Posted:
Aug 3, 2020
Last Verified:
Jul 1, 2020