Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)

Sponsor
ClarVista Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT03681886
Collaborator
(none)
150
Enrollment
2
Arms
23.2
Actual Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Harmoni Modular Intraocular Lens
  • Procedure: Optic Exchange
N/A

Detailed Description

All subjects were implanted with the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes based on the best interest of the subject and the clinical judgment the Investigator (Day 0, primary implantation) (Cohort 1). At Month 1 post primary implantation, subjects were given the option to undergo an optic exchange procedure. Subjects who underwent the optic exchange (Cohort 2) (Day 0, optic exchange) were followed for an additional month. Subjects who did not undergo an optic exchange were exited from the study, except at 1 site, which followed subjects up to Month 12.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
Actual Study Start Date :
Jan 9, 2016
Actual Primary Completion Date :
Dec 14, 2017
Actual Study Completion Date :
Dec 14, 2017

Arms and Interventions

ArmIntervention/Treatment
Experimental: Primary Implantation (Cohort 1)

Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.

Device: Harmoni Modular Intraocular Lens
Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag.
Other Names:
  • HMIOL
  • Experimental: Optic Exchange (Cohort 2)

    Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange

    Device: Harmoni Modular Intraocular Lens
    Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag.
    Other Names:
  • HMIOL
  • Procedure: Optic Exchange
    Removal of one optic and replacement with another for the purpose of improving refractive outcomes

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 [Day 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation]

      Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

    2. Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 [Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange]

      Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL.

    3. Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 [Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation]

      Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

    4. Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 [Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange]

      Visual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.

    5. Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 [Baseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation]

      A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.

    6. Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 [Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange]

      A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.

    7. Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort [Day 0 primary implantation]

      The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

    8. Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort [Day 0 primary implantation]

      The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

    9. Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 [Day 0 post-exchange]

      The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

    10. Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 [Day 0 post-exchange]

      The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

    11. Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 [Day 0 post-exchange]

      The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.

    12. Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) [Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.]

      A secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes, as determined by the investigator. No formal statistical hypothesis testing was planned.

    13. Number of Device Deficiencies [Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.]

      A device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    • Able to understand and sign an approved Informed Consent Form (ICF);

    • Willing and able to return for scheduled treatment and follow-up examinations;

    • Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;

    Key Exclusion Criteria:
    • Any ocular conditions which could affect the stability of the IOL in either eye;

    • Traumatic or congenital cataract;

    • Pregnancy or planned pregnancy during the study period;

    • Medications that may confound the outcome or increase risk to the subject;

    • Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • ClarVista Medical

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    ClarVista Medical
    ClinicalTrials.gov Identifier:
    NCT03681886
    Other Study ID Numbers:
    • CVM-00001
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 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
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by ClarVista Medical
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsA total of 5 Investigators participated in the study; 3 in the Philippines, 1 in Mexico, and 1 in Panama.
    Pre-assignment DetailOf the 150 subjects enrolled, 72 were exited from the study prior to attempted implantation with the HARMONI™ Modular Intraocular Lens (HMIOL) System. This reporting group includes all subjects / eyes with attempted implantation.
    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionImplantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
    Period Title: Overall Study
    STARTED78
    Successful Implantation76
    Failed Implantation2
    Underwent Optic Exchange4
    COMPLETED76
    NOT COMPLETED2

    Baseline Characteristics

    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionAll subjects with attempted implantation of the HARMONI™ Modular Intraocular Lens (HMIOL) System in the right eye, left eye, or both eyes
    Overall Participants78
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68.4
    (8.98)
    Sex: Female, Male (Count of Participants)
    Female
    47
    60.3%
    Male
    31
    39.7%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    50
    64.1%
    Black
    0
    0%
    Caucasian
    0
    0%
    Other
    28
    35.9%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
    DescriptionVisual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
    Time FrameDay 1 post primary implantation, Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 1 - Day 1 Post Primary ImplantationCohort 1 - Week 1 Post Primary ImplantationCohort 1 - Month 1 Post Primary ImplantationCohort 1 - Month 3 Post Primary ImplantationCohort 1 - Month 6 Post Primary ImplantationCohort 1 - Month 12 Post Primary Implantation
    Arm/Group DescriptionPrimary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
    Measure Participants747575121212
    Measure eyes969797121212
    20/20 Snellen or Better
    30.2
    32.0
    32.0
    16.7
    58.3
    25.0
    20/25 Snellen or Better
    53.1
    61.9
    60.8
    58.3
    83.3
    50.0
    20/32 Snellen or Better
    74.0
    84.5
    78.4
    91.7
    91.7
    66.7
    20/40 Snellen or Better
    85.4
    89.7
    93.8
    91.7
    100.0
    100.0
    Worse than 20/40 Snellen
    14.6
    10.3
    6.2
    3.3
    0.0
    0.0
    2. Primary Outcome
    TitlePercentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
    DescriptionVisual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned. The optic exchange occurred 1 month following primary implantation with HMIOL.
    Time FrameDay 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 2 - Day 0 Pre Optic ExchangeCohort 2 - Day 1 Post Optic ExchangeCohort 2 - Week 1 Post Optic ExchangeCohort 2 - Month 1 Post Optic Exchange
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants3333
    Measure eyes3333
    20/20 Snellen or Better
    0.0
    66.7
    66.7
    66.7
    20/25 Snellen or Better
    0.0
    66.7
    66.7
    66.7
    20/32 Snellen or Better
    0.0
    66.7
    100.0
    100.0
    20/40 Snellen or Better
    66.7
    100.0
    100.0
    100.0
    Worse than 20/40 Snellen
    33.3
    0.0
    0.0
    0.0
    3. Primary Outcome
    TitlePercentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
    DescriptionVisual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
    Time FrameBaseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 1 - Baseline (Day -90 to Day 0 Preoperative)Cohort 1 - Week 1 Post Primary ImplantationCohort 1 - Month 1 Post Primary ImplantationCohort 1 - Month 3 Post Primary ImplantationCohort 1 - Month 6 Post Primary ImplantationCohort 1 - Month 12 Post Primary Implantation
    Arm/Group DescriptionPrimary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
    Measure Participants717575121212
    Measure eyes929797121212
    20/20 Snellen or Better
    13.0
    76.3
    72.2
    83.3
    91.7
    58.3
    20/25 Snellen or Better
    23.9
    83.5
    92.8
    100.0
    100.0
    91.7
    20/32 Snellen or Better
    44.6
    94.8
    96.9
    100.0
    100.0
    100.0
    20/40 Snellen or Better
    58.7
    96.9
    99.0
    100.0
    100.0
    100.0
    Worse than 20/40 Snellen
    41.3
    3.1
    1.0
    0.0
    0.0
    0.0
    4. Primary Outcome
    TitlePercentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
    DescriptionVisual acuity of the eye was tested while reading charts at 20-foot equivalent distance from the participant with subject manifest refraction in place. BCDVA was recorded in Snellen, with 20/20 considered to be 'normal' vision. A visual acuity of 20/40 means the participant is able to read a certain size letter 20 feet away that a person with 'normal' vision would be able to read from 40 feet away. A larger denominator, therefore, indicates a lower visual acuity. No formal statistical hypothesis testing was planned.
    Time FrameBaseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 2 - Baseline (Day 0 Pre Optic Exchange),Cohort 2 - Week 1 Post Optic ExchangeCohort 2 - Month 1 Post Optic Exchange
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants333
    Measure eyes333
    20/20 Snellen or Better
    33.3
    100.0
    66.7
    20/25 Snellen or Better
    66.7
    100.0
    100.0
    20/32 Snellen or Better
    100.0
    100.0
    100.0
    20/40 Snellen or Better
    100.0
    100.0
    100.0
    Worse than 20/40 Snellen
    0.0
    0.0
    0.0
    5. Primary Outcome
    TitleMean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
    DescriptionA manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
    Time FrameBaseline (Day -90 to Day 0 preoperative), Week 1 post primary implantation, Month 1 post primary implantation, Month 3 post primary implantation, Month 6 post primary implantation, Month 12 post primary implantation

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 1 - Baseline (Day -90 to Day 0 Preoperative)Cohort 1 - Week 1 Post Primary ImplantationCohort 1 - Month 1 Post Primary ImplantationCohort 1 - Month 3 Post Primary ImplantationCohort 1 - Month 6 Post Primary ImplantationCohort 1 - Month 12 Post Primary Implantation
    Arm/Group DescriptionPrimary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
    Measure Participants757575121212
    Measure eyes979797121212
    Mean (Standard Deviation) [diopter]
    -0.53
    (2.70)
    -0.28
    (0.62)
    -0.29
    (0.63)
    -0.58
    (0.57)
    -0.49
    (0.61)
    -0.40
    (0.69)
    6. Primary Outcome
    TitleMean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
    DescriptionA manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The subject was manually refracted to his/her best correction. The manifest refraction spherical equivalent (MRSE) was measured in diopters (D) and calculated as follows: sphere + 1/2 cylinder. A less negative value indicates a more accurate IOL power calculation. No formal statistical hypothesis testing was planned.
    Time FrameBaseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange

    Outcome Measure Data

    Analysis Population Description
    Per Protocol: All subjects/eyes with successful implantation of HMIOL with no major protocol deviations and available data.
    Arm/Group TitleCohort 2 - Baseline (Day 0 Pre Optic Exchange)Cohort 2 - Week 1 Post Optic ExchangeCohort 2 - Month 1 Post Optic Exchange
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchangeSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants333
    Measure eyes333
    Mean (Standard Deviation) [diopter]
    -1.54
    (0.56)
    -0.25
    (0.25)
    -0.17
    (0.29)
    7. Primary Outcome
    TitleNumber of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
    DescriptionThe surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 primary implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionPrimary implantation with HMIOL
    Measure Participants76
    Measure eyes98
    Easier than a traditional single piece IOL
    35
    Slightly easier than a traditional single piece IO
    16
    The same as a traditional single piece IOL
    11
    Slightly more difficult than a trd'l single pc IOL
    34
    More difficult than a traditional single piece IOL
    2
    8. Primary Outcome
    TitleNumber of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
    DescriptionThe surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 primary implantation

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionPrimary implantation with HMIOL
    Measure Participants76
    Measure eyes98
    Very easy
    31
    Easy
    23
    Neutral
    35
    Difficult
    8
    Very difficult
    1
    9. Primary Outcome
    TitleNumber of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2
    DescriptionThe surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 post-exchange

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleCohort 2
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants4
    Measure eyes4
    Very easy
    1
    Easy
    1
    Neutral
    2
    10. Primary Outcome
    TitleNumber of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
    DescriptionThe surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 post-exchange

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleCohort 2
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants4
    Measure eyes4
    Very easy
    1
    Easy
    3
    11. Primary Outcome
    TitleNumber of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
    DescriptionThe surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
    Time FrameDay 0 post-exchange

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleCohort 2
    Arm/Group DescriptionSubset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
    Measure Participants4
    Measure eyes4
    Very easy
    1
    Easy
    1
    Neutral
    2
    12. Primary Outcome
    TitleNumber of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
    DescriptionA secondary surgical intervention (SSI) was defined as a surgical procedure that occurred after primary implantation and was conducted for the purpose of resolving residual refractive error (RRE) and optimizing visual outcomes, as determined by the investigator. No formal statistical hypothesis testing was planned.
    Time FrameCohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionPrimary implantation with HMIOL
    Measure Participants78
    Measure eyes100
    Number [SSI]
    4
    13. Primary Outcome
    TitleNumber of Device Deficiencies
    DescriptionA device deficiency was defined as a failure of the device to meet its performance specifications or expectations, or otherwise not perform as intended. This could include either a malfunction or damage to the device or any part thereof, regardless of the source of malfunction or damage, including user error, and regardless of the presence of injury (or lack thereof) to subject, user, or bystander. No formal statistical hypothesis testing was planned.
    Time FrameCohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.

    Outcome Measure Data

    Analysis Population Description
    Safety Population: All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye) and available data
    Arm/Group TitleAll HMIOL Cohort
    Arm/Group DescriptionPrimary implantation with HMIOL
    Measure Participants78
    Measure eyes100
    Number [device deficiencies]
    4

    Adverse Events

    Time FrameAdverse events (AEs) were collected from time of consent to study exit: Cohort 1: Up to one month post primary implantation, with one site followed up to 12 months. Cohort 2: Up to one month post exchange, for a total of up to 2 months.
    Adverse Event Reporting Description AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes.
    Arm/Group TitleNon-OcularOcular
    Arm/Group DescriptionAll subjects with attempted HMIOL implantation (successful or aborted after contact with the eye)All eyes with attempted HMIOL implantation (successful or aborted after contact with the eye)
    All Cause Mortality
    Non-OcularOcular
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/78 (0%) 0/100 (0%)
    Serious Adverse Events
    Non-OcularOcular
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/78 (0%) 0/100 (0%)
    Other (Not Including Serious) Adverse Events
    Non-OcularOcular
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/78 (0%) 12/100 (12%)
    Eye disorders
    Iridocyclitis0/78 (0%) 6/100 (6%)
    Investigations
    Intraocular pressure increased0/78 (0%) 9/100 (9%)

    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, LLC
    Phone1-888-451-3937
    Emailalcon.medinfo@alcon.com
    Responsible Party:
    ClarVista Medical
    ClinicalTrials.gov Identifier:
    NCT03681886
    Other Study ID Numbers:
    • CVM-00001
    First Posted:
    Sep 24, 2018
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020