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

Cataract Clinical Trial

Official title:

Evaluation of Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03681886
• Other study ID #: CVM-00001
• Status: Completed
• Phase: N/A
• Start date: January 9, 2016
• Est. completion date: December 14, 2017

Study information

• Verified date: December 2020
• Source: ClarVista Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

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.

Procedure:
• Optic Exchange
Removal of one optic and replacement with another for the purpose of improving refractive outcomes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ClarVista Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	Day 0 pre optic exchange, Day 1 post optic exchange, Week 1 post optic exchange, Month 1 post optic exchange
Primary	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.	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
Primary	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.	Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Primary	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.	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
Primary	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.	Baseline (Day 0 pre optic exchange), Week 1 post optic exchange, Month 1 post optic exchange
Primary	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.	Day 0 primary implantation
Primary	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.	Day 0 primary implantation
Primary	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.	Day 0 post-exchange
Primary	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.	Day 0 post-exchange
Primary	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.	Day 0 post-exchange
Primary	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.	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.
Primary	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.	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.