Clinical trial NCT03050697: Evaluation of the Safety and Performance of the HARMONI® Toric Lens
Official title: A Prospective, Multicenter Study to Evaluate the Safety and Performance of the Exchangeable ClarVista HARMONI Modular Toric Intraocular Lens System for the Treatment of Pre-Existing Corneal Astigmatism and Aphakia Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Corneal Astigmatism
Cataract
Keywords: Toric
Intraocular lens
Lead sponsor: ClarVista Medical
Sponsor class: INDUSTRY
First posted: 2017-02-13
Enrollment: 16
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects with visually significant bilateral cataracts (cortical, nuclear, posterior subcapsular, or a combination) were implanted unilaterally (in one eye only) or bilaterally (in both eyes) with the HMTIOL. A total of 7 study visits were planned, including a preoperative visit, operative visits for each eye, and 4 follow-up visits at 1 day, 1 week, 1 month, and 3 months postoperative. The total duration of participation for each subject was up to 6 months, including the preoperative period (up to 3 months).

Alcon Research, LLC, acquired ClarVista Medical in 2017. This study was designed and conducted by ClarVista Medical, Inc. The study results were collected, analyzed, and provided by ClarVista Medical, Inc. to Alcon Research, LLC.

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.

Primary outcomes:
measure: Mean Manifest Refraction Cylinder (MRCYL) for Eyes Implanted With HMTIOL
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: Mean Manifest Refraction Cylinder (MRCYL) Prediction Error (PE) for Eyes Implanted With HMTIOL
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: MRCYL PE for Eyes Implanted With HMTIOL Per Vector Analyses
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: Mean Reduction in Cylinder Power for Eyes Implanted With HMTIOL
timeFrame: Baseline (Day 0 preoperative), Month 3 postoperative
measure: Mean Percent Reduction in Cylinder Power for Eyes Implanted With HMTIOL
timeFrame: Baseline (Day 0 preoperative), Month 3 postoperative
measure: Mean Manifest Refraction Spherical Equivalent (MRSE) Prediction Error (PE)
timeFrame: Month 1 postoperative, Month 3 postoperative
measure: Mean Absolute Misalignment of IOL Meridian - Target Versus Actual at Operative Visit
timeFrame: Day 0 (operative)
measure: Mean Absolute Rotation of IOL Meridian by Visit
timeFrame: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Number of Eyes With Absolute Rotation of IOL Meridian by Visit
timeFrame: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) by Visit
timeFrame: Baseline (Day 0 preoperative), Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Percentage of Eyes With Uncorrected Distance Visual Acuity (UCDVA) by Visit
timeFrame: Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative
measure: Standard Error of the Mean in Lens Power A-constant for Refinement
timeFrame: Day 0 operative
measure: Number of Ocular Adverse Events Through Month 3
timeFrame: Up to Month 3 postoperative
measure: Number of Device-Related Secondary Surgical Interventions (SSI) Other Than Optic Exchange and Rotational Adjustment of the HMTIOL
timeFrame: Up to Month 3 postoperative
measure: Number of Device Deficiencies Post Implantation
timeFrame: Up to Month 3 postoperative
measure: Number of Eyes With Preservation of Best Corrected Distance Visual Acuity (BCDVA) at Month 1 and Month 3
timeFrame: Month 1 postoperative, Month 3 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: ClarVista Investigative Site
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Trial Lead, CDMA Surgical
role: STUDY_DIRECTOR
References: