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

ClarVista Medical

Status: Completed

Conditions: Cataract

Treatments: Device: Commercially Available Intraocular Lens; Procedure: Optic exchange; Device: Harmoni Modular Intraocular Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT02521766

CP-00001

Details and patient eligibility

About

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).

Full description

Eligible subjects with bilateral cataracts underwent cataract extraction and IOL implantation using phacoemulsification. The study eye was implanted with the investigational device (All HMIOL Cohort). The fellow eye was treated with a commercially available intraocular lens (IOL) per standard of care procedure. At the scheduled Month 3 post-operative visit, subjects who did not opt to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 1 and followed for an additional 6 months. The total duration of participation for Cohort 1 was up to 15 months, which included a Day -90 to Day -1 preoperative period and a 12 month post-operative follow-up period. At the scheduled Month 3 post-operative visit, subjects who elected to pursue an optic exchange procedure in the study eye were enrolled into subgroup Cohort 2 and followed for an additional 12 months. The total duration of participation for Cohort 2 was up to 18 months, which included a Day -90 to Day -1 preoperative period, an optic exchange at Month 3 postoperative, and a 12 month post-exchange follow-up period.

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc., to evaluate the safety and effectiveness of the HMIOL. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

Enrollment: 217 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Other protocol-specified inclusion criteria may apply.

Exclusion criteria

• 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
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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217 participants in 4 patient groups

All HMIOL Cohort

Experimental group

Description:

HMIOL implantation with or without optic exchange

Treatment:

Device: Harmoni Modular Intraocular Lens

Cohort 1

Experimental group

Description:

HMIOL implantation with no optic exchange

Treatment:

Device: Harmoni Modular Intraocular Lens

Cohort 2

Experimental group

Description:

HMIOL implantation with optic exchange

Treatment:

Device: Harmoni Modular Intraocular Lens

Procedure: Optic exchange

Fellow Eye

Other group

Description:

IOL implantation per standard of care

Treatment:

Device: Commercially Available Intraocular Lens