A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery

NCT02521766 | Completed Results FDA Device

• 1 other identifier: CP-00001
• Study Type: interventional
• Target: 217
• Locations: 2 countries
• Sites: 2

Brief Summary

The main objectives of this feasibility study were:

• To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and
• To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).

Conditions

Cataract

Keywords

Cataract; IOL; Modular IOL; IOL exchange

Outcome Measures

Primary Outcomes (18)

• Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort

  Visual acuity (VA) was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS)-Fast method under well-lit conditions at a distance of 4 meters (m) with the correction obtained from manifest refraction testing. 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Month 1 postoperative, Month 3 postoperative

• Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative

• Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned

  Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange

• Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. 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. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Month 1 postoperative, Month 3 postoperative, Month 12 postoperative

• Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort

  A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1

  A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative

• Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2

  A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange

• Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye

  A manifest refraction (manual vision test) was conducted using letter charts and a phoropter. The manifest refraction spherical equivalent (MRSE) was calculated as follows: sphere + 1/2 cylinder, and measured in diopters (D). This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.

  Month 1 postoperative, Month 3 postoperative, Month 12 postoperative

• Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day -90 to Day -1 preoperative, Month 1 postoperative, Month 3 postoperative

• Mean BCDVA (Letters Read) by Study Visit - Cohort 1

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative

• Mean BCDVA (Letters Read) by Study Visit - Cohort 2

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Month 1 postoperative and Month 3 postoperative visits were pre-optic exchange.This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange

• Mean BCDVA (Letters Read) by Study Visit - Fellow Eye

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with the correction obtained from manifest refraction testing. BCDVA was rrecorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.

  Day -90 to -1 preoperative, Month 1 postoperative, Month 3 postoperative, Month 12 postoperative

• Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

• Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative

• Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye. No formal statistical hypothesis testing was planned.

  Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exch

• Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m with an optical infinity adjustment of +0.25 diopter (D). UCDVA was recorded in letters read correctly. This analysis was prespecified for the fellow eye. No formal statistical hypothesis testing was planned.

  Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative, Month 6 postoperative, Month 12 postoperative

• Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2

  VA was assessed using the ETDRS-Fast method under well-lit conditions at a distance of 4 m 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. An optic exchange occurred at the Month 3 visit, after which subjects were followed for an additional 12 months. Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, and Month 3 postoperative visits were pre-optic exchange. This analysis was prespecified for the study eye, Cohort 2 only. No formal statistical hypothesis testing was planned.

  Day 1 post-optic exchange, Week 1 post-optic exchange, Month 1 post-optic exchange, Month 3 post-optic exchange, Month 6 post-optic exchange, Month 12 post-optic exchange

• Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort

  VA was assessed using the ETDRS-Fast method under mesopic (dimly lit) conditions at a distance of 4 m with the correction obtained from manifest refraction testing. Testing was performed with and without glare. Chart luminance was set to 3 cd/m2. mBCDVA was recorded in letters read correctly. This analysis was prespecified for the study eye, All HMIOL Cohort only. No formal statistical hypothesis testing was planned.

  Month 3 postoperative

Study Arms (4)

All HMIOL Cohort

EXPERIMENTAL

HMIOL implantation with or without optic exchange

Device: Harmoni Modular Intraocular Lens

Cohort 1

EXPERIMENTAL

HMIOL implantation with no optic exchange

Device: Harmoni Modular Intraocular Lens

Cohort 2

EXPERIMENTAL

HMIOL implantation with optic exchange

Device: Harmoni Modular Intraocular Lens; Procedure: Optic exchange

Fellow Eye

OTHER

IOL implantation per standard of care

Device: Commercially Available Intraocular Lens

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

All HMIOL Cohort; Cohort 1; Cohort 2

Commercially Available Intraocular Lens DEVICE

IOL per investigator's standard of care

Fellow Eye

Optic exchange PROCEDURE

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

Cohort 2

Eligibility Criteria

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

You may qualify if:

• Must be able to understand and provide informed consent
• Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration
• Planned bilateral removal of visually significant bilateral cataracts
• Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes
• Preoperative bilateral BCDVA of 20/40 or worse
• Both eyes must have corneal astigmatism ≤ 1.50 diopter (D)
• Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study
• Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye

You may not qualify if:

• Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation
• History of any intraocular or corneal surgery in either eye (including refractive)
• History of any clinically significant retinal pathology or ocular diagnosis in either eye
• History of any ocular conditions which could affect the stability of the IOL
• Uncontrolled glaucoma in either eye

Sponsors & Collaborators

• ClarVista Medical: lead

Study Sites (2)

ClarVista Investigational Site

Auckland, 1050, New Zealand

Location

ClarVista Investigational Site

Makati City, Manila, 1200, Philippines

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

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

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Sr. CDMA Project Lead, 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 13, 2015
• Study Start: October 1, 2015
• Primary Completion: February 7, 2017
• Study Completion: October 26, 2017
• Last Updated: May 14, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1); NZ (1)