- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03681886
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / 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.
|
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:
|
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
|
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:
Removal of one optic and replacement with another for the purpose of improving refractive outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
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
|
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.
|
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
|
Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
Time Frame: 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.
|
Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
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
|
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.
|
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
|
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
Time Frame: 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.
|
Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
|
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1
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
|
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.
|
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
|
Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2
Time Frame: 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.
|
Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
|
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort
Time Frame: 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.
|
Day 0 primary implantation
|
Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort
Time Frame: 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.
|
Day 0 primary implantation
|
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
Time Frame: 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.
|
Day 0 post-exchange
|
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2
Time Frame: 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.
|
Day 0 post-exchange
|
Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2
Time Frame: 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.
|
Day 0 post-exchange
|
Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange)
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.
|
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.
|
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.
|
Number of Device Deficiencies
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.
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sr. Clinical Trial Lead, CDMA Surgical, Alcon Research, LLC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CVM-00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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