CompletedNot Applicable

ClarVista HARMONI Toric Trial With Intraoperative Exchange

Mexico, Philippines44 participantsStarted 2016-06-28

Plain-language 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.

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL

Timeframe: Month 1 postoperative, Month 3 postoperative

Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL

Timeframe: Month 1 postoperative, Month 3 postoperative

Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)

Timeframe: Month 3 postoperative

Mean Absolute Rotation of IOL Meridian

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

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

Trial details

NCT IDNCT03054649

SponsorClarVista Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07-18

Results submitted2020-06-02

View on ClinicalTrials.gov More Cataract trials

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL

Timeframe: Month 1 postoperative, Month 3 postoperative

Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL

Timeframe: Month 1 postoperative, Month 3 postoperative

Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL

Timeframe: Baseline (Day 0 preoperative), Month 3 postoperative

Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)

Timeframe: Month 3 postoperative

Mean Absolute Rotation of IOL Meridian

Timeframe: Baseline (Day 0 operative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative

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