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

NCT03681886 | Completed Results FDA Device

• 1 other identifier: CVM-00001
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Aphakia

Keywords

intraocular lens; IOL; intraoperative exchange

Outcome Measures

Primary Outcomes (13)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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.

• 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.

Study Arms (2)

Primary Implantation (Cohort 1)

EXPERIMENTAL

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

Device: Harmoni Modular Intraocular Lens

Optic Exchange (Cohort 2)

EXPERIMENTAL

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; Procedure: Optic Exchange

Interventions

Harmoni Modular Intraocular Lens DEVICE

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.

Also known as: HMIOL

Optic Exchange (Cohort 2); Primary Implantation (Cohort 1)

Optic Exchange PROCEDURE

Removal of one optic and replacement with another for the purpose of improving refractive outcomes

Optic Exchange (Cohort 2)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• ClarVista Medical: lead

MeSH Terms

Conditions

Cataract; Aphakia

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Trial Lead, CDMA Surgical
• Organization: Alcon, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. Clinical Trial Lead, CDMA Surgical

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: January 9, 2016
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share