N/A Completed N=114 Single-blind Treatment

A Clinical Investigation of the ClarVista HARMONI™ Modular Intraocular Lens Implant Following Cataract Surgery

Cataract

Source: ClinicalTrials.gov NCT02521766 ↗

Enrolled (actual)

114

Serious AEs

2.4%

Results posted

Mar 2020

Primary outcomePrimary: Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort — 99.1; 100.0 percentage of eyes

Summary

The main objectives of this feasibility study were: * To demonstrate the feasibility of HARMONI Modular Intraocular Lens (HMIOL) implantation and assembly in subjects undergoing cataract surgery (All HMIOL Cohort), and * To demonstrate the feasibility of the HMIOL optic component exchange procedure (performed 3 months following primary cataract extraction) (Cohort 2).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - All HMIOL Cohort	99.1; 100.0	—
PRIMARY Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 1	100.0; 100.0; 100.0; 100.0	—
PRIMARY Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Cohort 2	98.5; 100; 100; 100; 100; 100	—
PRIMARY Percentage of Eyes With Postoperative BCDVA 20/40 Snellen or Better by Study Visit - Fellow Eye	100.0; 100.0; 100.0	—
PRIMARY Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - All HMIOL Cohort	33.9; 70.6; 26.8; 61.6; 19.6; 52.7	—
PRIMARY Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 1	31.1; 57.8; 23.4; 48.9; 19.1; 44.7	—
PRIMARY Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Cohort 2	35.9; 79.7; 29.2; 70.8; 20.0; 58.5	—
PRIMARY Percentage of Eyes With Postoperative Manifest Refraction Spherical Equivalent (MRSE) Within Target by Study Visit - Fellow Eye	78.5; 98.1; 81.1; 99.1; 72.2; 97.2	—
PRIMARY Mean BCDVA (Letters Read) by Study Visit - All HMIOL Cohort	75.2; 84.6; 85.4	—
PRIMARY Mean BCDVA (Letters Read) by Study Visit - Cohort 1	79.9; 85.8; 86.7; 86.2; 86.2	—
PRIMARY Mean BCDVA (Letters Read) by Study Visit - Cohort 2	71.8; 83.7; 84.4; 84.5; 85.1; 85.2	—
PRIMARY Mean BCDVA (Letters Read) by Study Visit - Fellow Eye	74.5; 86.3; 86.9; 86.9	—
PRIMARY Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - All HMIOL Cohort	71.5; 70.4; 70.6; 73.4	—
PRIMARY Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 1	74.8; 73.7; 75.4; 77.1; 78.1; 77.9	—
PRIMARY Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Cohort 2	69.1; 68.1; 67.2; 70.7; 76.8; 79.8	—
PRIMARY Mean Uncorrected Distance Visual Acuity (UCDVA) (Letters Read) by Study Visit - Fellow Eye	80.6; 81.3; 81.3; 82.4; 83.0; 82.1	—
PRIMARY Percentage of Eyes With UCDVA by Category (Snellen) for Each Post-optic Exchange Study Visit - Cohort 2	41.5; 47.7; 53.1; 49.2; 55.6; 50.0	—
PRIMARY Mesopic Best Corrected Distance Visual Acuity (mBCDVA) (With and Without Glare) (Letters Read) at Study Visit - All HMIOL Cohort	81.0; 81.1	—

Eligibility Criteria

Inclusion Criteria

Must be able to understand and provide informed consent
Must be willing and able to return for scheduled treatment and follow-up examinations for up to 15 month study duration
Planned bilateral removal of visually significant bilateral cataracts
Best-corrected distance visual acuity (BCDVA) projected to be better than 20/32 after IOL implantation in both eyes
Preoperative bilateral BCDVA of 20/40 or worse
Both eyes must have corneal astigmatism ≤ 1.50 diopter (D)
Women must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study
Dilated pupil size equal to or greater than 6 millimeters (mm) in primary study eye
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation
History of any intraocular or corneal surgery in either eye (including refractive)
History of any clinically significant retinal pathology or ocular diagnosis in either eye
History of any ocular conditions which could affect the stability of the IOL
Uncontrolled glaucoma in either eye
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02521766). 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.