ClarVista HARMONI Toric Trial With Intraoperative Exchange

NCT ID: NCT03054649

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-28
• Study Completion Date: 2017-07-18

Brief Summary

The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.

Detailed Description

Subjects were implanted with the HARMONI® Modular Intraocular Lens System (HMIOL). The eye with the higher corneal astigmatism (study eye) was assigned to Cohort 1 and received the HARMONI® Modular Intraocular Lens System with a toric optic. The fellow eye was assigned to Cohort 2 and received the HARMONI® Modular Intraocular Lens System with a non-toric optic during primary implantation, which was replaced with the appropriate optic power (toric or non-toric) during an intraoperative exchange (IOE) procedure. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, which included a Day -90 to Day -0 preoperative period.

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.

Conditions

Cataract; Corneal Astigmatism; Aphakia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

Study eye: Primary implantation of HMIOL system with toric optic and no intraoperative optic exchange

Group Type: EXPERIMENTAL

HARMONI® Modular Intraocular Lens System

Intervention Type: 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

Cohort 2

Fellow eye: Primary implantation of HMIOL system with monofocal optic, followed by intraoperative optic exchange (toric or non-toric optic)

Group Type: EXPERIMENTAL

HARMONI® Modular Intraocular Lens System

Intervention Type: 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

Intraoperative optic exchange

Intervention Type: PROCEDURE

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

Interventions

HARMONI® Modular Intraocular Lens System

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

Intervention Type: DEVICE

Intraoperative optic exchange

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

Intervention Type: PROCEDURE

Other Intervention Names

HMIOL; IOE

Eligibility Criteria

Inclusion Criteria

• Willing and able to return for scheduled treatment and follow-up examinations for up to 6 month study duration.
• Planned removal of visually significant bilateral cataracts.
• Pre-existing corneal astigmatism in at least 1 eye.
• Willing to discontinue contact lens wear for the duration of the study.
• Best Corrected Visual Acuity (BCVA) projected to be 0.2 logarithm Minimum Angle of Resolution (logMAR) or lower.
• Visual symptoms related to cataracts.

Exclusion Criteria

• History of any intraocular or corneal surgery in either eye (including refractive).
• Pregnant or lactating.
• History of any clinically significant retinal pathology or ocular diagnosis in either eye that could alter or limit final postoperative visual prognosis.
• History of any ocular condition which could affect the stability of the intraocular lens (IOL) in either eye.
• Uncontrolled glaucoma in either eye (per Investigator judgement).
• Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClarVista Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sr. Clinical Trial Lead, CDMA Surgical

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

ClarVista Investigative Site

Tijuana, Estado de Baja California, Mexico

ClarVista Investigative Site

Makati, Manila, Philippines

Countries

Mexico; Philippines

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CP-00002

Identifier Type: -

Identifier Source: org_study_id