N/A
Completed N=12
Evaluation of the Safety and Performance of the HARMONI® Toric Lens
Aphakia · Corneal Astigmatism · Cataract
Source: ClinicalTrials.gov NCT03050697 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL — -0.50; -0.57 diopter
Summary
The purpose of this study was to evaluate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic (HMTIOL) 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 |
-0.50; -0.57 | — |
| PRIMARY Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL |
0.01; -0.03 | — |
| PRIMARY MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses |
— | — |
| PRIMARY Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL |
1.15 | — |
| PRIMARY Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL |
76.2 | — |
| PRIMARY Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE) |
0.14; 0.26 | — |
| PRIMARY Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit |
2.6 | — |
| PRIMARY Mean Absolute Rotation of IOL Meridian by Visit |
1.9; 2.3; 2.9; 2.4 | — |
| PRIMARY Number of Eyes With Absolute Rotation of IOL Meridian by Visit |
12; 12; 12; 12; 1; 1 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit |
35.3; 82.4; 82.4; 88.2; 47.1; 88.2 | — |
| PRIMARY Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit |
0.0; 23.5; 52.9; 47.1; 52.9; 5.9 | — |
| PRIMARY Standard Error of the Mean in Lens Power A-constant for Refinement |
— | — |
| PRIMARY Number of Ocular Adverse Events Through Month 3 |
1; 1; 1; 1; 1 | — |
| PRIMARY Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL |
1 | — |
| PRIMARY Number of Device Deficiencies Post Implantation |
— | — |
| PRIMARY Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3 |
16; 16; 1; 1; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Planned removal of visually significant bilateral cataract by manual phacoemulsification cataract extraction
- Pre-existing corneal astigmatism in at least 1 eye of 0.75 to 2.50 diopter (D)
- Target dioptric lens power within the range of 16 - 26 D
- Willing to discontinue contact lens wear for the duration of the study
- BCVA projected to be ≤0.2 logarithm minimum angle of resolution (LogMAR)
- Stable cornea
- Dilated pupil size at least 7.0 millimeters (mm)
- Able to understand and provide informed consent.
Key Exclusion Criteria
- History of any intraocular or corneal surgery in study eye (including refractive)
- Pregnant or lactating
- History of any clinically significant retinal pathology or ocular diagnosis in study eye that could alter or limit final postoperative visual prognosis
- History of ocular conditions which could affect the stability of the IOL in study eye
- Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction in study eye
- Any visually significant intraocular media opacity other than cataract in study eye
- Uncontrolled glaucoma in study eye
- Uncontrolled systemic disease
- Severe dry eye that would impair the ability to obtain reliable study measurements
- Systemic medication that may confound the outcome or increase the intraoperative and postoperative risk to the subject.
Data sourced from ClinicalTrials.gov (NCT03050697). 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.