N/A
Completed N=54
ClarVista HARMONI Toric Trial With Intraoperative Exchange
Cataract · Corneal Astigmatism · Aphakia
Source: ClinicalTrials.gov NCT03054649 ↗
Enrolled (actual)
54
Serious AEs
1.8%
Results posted
Jun 2020
Primary outcomePrimary: Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL — -0.54; -0.75; -0.58; -0.72 diopter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL |
-0.54; -0.75; -0.58; -0.72 | — |
| PRIMARY Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL |
-0.30; -0.53; -0.33; -0.44 | — |
| PRIMARY Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL |
0.79; 0.53 | — |
| PRIMARY Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL |
54.9; 39.5 | — |
| PRIMARY Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) |
0.03; -0.12 | — |
| PRIMARY Mean Absolute Rotation of IOL Meridian |
1.8; 2.1; 2.4; 1.6; 3.1; 2.3 | — |
| PRIMARY Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 1 |
22; 23; 23; 22; 0; 0 | — |
| PRIMARY Number of Eyes With Absolute Rotation of IOL Meridian by Visit - Cohort 2 |
20; 17; 18; 19; 0; 0 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 |
22.2; 66.7; 59.3; 70.4; 51.9; 77.8 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 |
23.1; 76.9; 73.1; 76.9; 57.7; 84.6 | — |
| PRIMARY Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 |
3.7; 48.1; 44.4; 40.7; 40.7; 14.8 | — |
| PRIMARY Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 |
0.0; 46.2; 53.8; 42.3; 34.6; 3.8 | — |
| PRIMARY Number of Eyes With Preservation of BCDVA at Month 1 and Month 3 |
27; 25; 25; 26; 0; 2 | — |
| PRIMARY Number of Ocular Adverse Events Through Month 3 |
1; 0; 1; 1; 0; 1 | — |
| PRIMARY Number of Device Deficiencies Post Implantation |
0; 0 | — |
| PRIMARY Number of Secondary Surgical Interventions, Other Than Intraroperative Optic Exchange and Rotational Adjustment of the Toric Optic in Cohort 2 |
0; 0 | — |
| PRIMARY Percent Change in Endothelial Cell Count (ECC) at Month 3 |
-12.5; -9.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT03054649). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.