N/A
Completed N=78
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
Cataract · Aphakia
Source: ClinicalTrials.gov NCT03681886 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 — 30.2; 32.0; 32.0; 16.7 percentage of eyes
Summary
The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 1 |
30.2; 32.0; 32.0; 16.7; 58.3; 25.0 | — |
| PRIMARY Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit - Cohort 2 |
0.0; 66.7; 66.7; 66.7; 0.0; 66.7 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 1 |
13.0; 76.3; 72.2; 83.3; 91.7; 58.3 | — |
| PRIMARY Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit - Cohort 2 |
33.3; 100.0; 66.7; 66.7; 100.0; 100.0 | — |
| PRIMARY Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 1 |
-0.53; -0.28; -0.29; -0.58; -0.49; -0.40 | — |
| PRIMARY Mean Manifest Refraction Spherical Equivalent (MRSE) by Visit - Cohort 2 |
-1.54; -0.25; -0.17 | — |
| PRIMARY Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Base Implantation? - All HMIOL Cohort |
35; 16; 11; 34; 2 | — |
| PRIMARY Number of Surgeon Responses to Primary Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly? - All HMIOL Cohort |
31; 23; 35; 8; 1 | — |
| PRIMARY Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Implantation and Assembly (Exchange)? - Cohort 2 |
1; 1; 2 | — |
| PRIMARY Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Disassembly? - Cohort 2 |
1; 3 | — |
| PRIMARY Number of Surgeon Responses to Optic Exchange Surgery Question: How Would You Rate the Surgical Difficulty of the Optic Explantation? - Cohort 2 |
1; 1; 2 | — |
| PRIMARY Number of Secondary Surgical Interventions (SSI) (Other Than Optic Exchange) |
4 | — |
| PRIMARY Number of Device Deficiencies |
4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Able to understand and sign an approved Informed Consent Form (ICF);
- Willing and able to return for scheduled treatment and follow-up examinations;
- Planned removal of cataracts (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction;
Key Exclusion Criteria
- Any ocular conditions which could affect the stability of the IOL in either eye;
- Traumatic or congenital cataract;
- Pregnancy or planned pregnancy during the study period;
- Medications that may confound the outcome or increase risk to the subject;
- Any clinical finding or intraocular complication during primary cataract surgery or Implantation of the lens system likely to increase complications or risk to the subject;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03681886). 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.