Back to resultsVisual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
Primary Purpose
Cataract, Aphakia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Harmoni Modular Intraocular Lens
Optic Exchange
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring intraocular lens, IOL, intraoperative exchange
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Primary Implantation (Cohort 1)
Optic Exchange (Cohort 2)
Arm Description
Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
Outcomes
Primary Outcome Measures
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
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.
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
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.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
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.
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
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.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
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.
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
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.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
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
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
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.
Number of Device Deficiencies
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03681886
Brief Title
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
Official Title
Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 9, 2016 (Actual)
Primary Completion Date
December 14, 2017 (Actual)
Study Completion Date
December 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClarVista Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Aphakia
Keywords
intraocular lens, IOL, intraoperative exchange
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Implantation (Cohort 1)
Arm Type
Experimental
Arm Description
Primary implantation with HMIOL through Month 1 visit, followed by study exit. 1 site followed up to Month 12.
Arm Title
Optic Exchange (Cohort 2)
Arm Type
Experimental
Arm Description
Subset of Cohort 1 with optic exchange at Month 1 post primary implantation, followed up to Month 1 post optic exchange
Intervention Type
Device
Intervention Name(s)
Harmoni Modular Intraocular Lens
Other Intervention Name(s)
HMIOL
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Optic Exchange
Intervention Description
Removal of one optic and replacement with another for the purpose of improving refractive outcomes
Primary Outcome Measure Information:
Title
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
Description
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.
Time Frame
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
Title
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
Description
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.
Time Frame
Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
Title
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
Description
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.
Time Frame
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
Title
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Description
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.
Time Frame
Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Title
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
Description
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.
Time Frame
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
Title
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
Description
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.
Time Frame
Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Title
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
Description
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time Frame
Day 0 primary implantation
Title
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
Description
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time Frame
Day 0 primary implantation
Title
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
Description
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time Frame
Day 0 post-exchange
Title
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
Description
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time Frame
Day 0 post-exchange
Title
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
Description
The surgeon's response was collected on a study-specific questionnaire after each surgery. No formal statistical hypothesis testing was planned.
Time Frame
Day 0 post-exchange
Title
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
Description
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.
Time Frame
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.
Title
Number of Device Deficiencies
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Clinical Trial Lead, CDMA Surgical
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
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