Clinical trial NCT03054649: ClarVista HARMONI Toric Trial With Intraoperative Exchange
Official title: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Corneal Astigmatism
Aphakia
Keywords: cataract
intraoperative exchange
intraocular lens
astigmatism
toric
Lead sponsor: ClarVista Medical
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 44
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Key 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.

Key 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

Primary outcomes:
measure: Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
timeFrame: Baseline (Day 0 preoperative), Month 3 postoperative
measure: Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
timeFrame: Baseline (Day 0 preoperative), Month 3 postoperative
measure: Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
timeFrame: Month 3 postoperative
measure: Mean Absolute Rotation of IOL Meridian
timeFrame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1
timeFrame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2
timeFrame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1
timeFrame: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2
timeFrame: Baseline (Day 0 operative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1
timeFrame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2
timeFrame: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Number of Eyes With Preservation of BCDVA at Month 1 and Month 3
timeFrame: Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Number of Ocular Adverse Events Through Month 3
timeFrame: Up to Month 3 postoperative
measure: Number of Device Deficiencies Post Implantation
timeFrame: Up to Month 3 postoperative
measure: Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2
timeFrame: Up to Month 3 postoperative
measure: Percent Change in Endothelial Cell Count (ECC) at Month 3
timeFrame: Baseline (preoperative), Month 3 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: ClarVista Investigative Site
state: Baja California
city: Makati
country: Philippines
facility: ClarVista Investigative Site
state: Manila
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: