Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Study Overview
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Brief Summary
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Prospective, multicenter, paired-eye, randomized, subject/evaluator-masked clinical investigation of the experimental EndoCoat OVD versus the control EndoCoat OVD.

Official Title
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Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)

Conditions
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Cataracts

Intervention / Treatment
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* Device: Investigational Healon Endocoat
* Device: Control Healon EndoCoat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minimum 22 years of age Cataracts for which extraction and posterior chamber IOL implantation have been planned in both eyes Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better Clear intraocular media, other than cataract Availability, willingness and sufficient cognitive awareness to comply with examination procedures Signed informed consent and HIPAA authorization Exclusion Criteria: Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical outcomes or increase risk to the subject Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study. Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery) Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects Use of systemic or ocular medications that may affect vision or IOP Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study, or in the opinion of the investigator, may confound the outcome(s) of the study Poorly-controlled diabetes Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Known steroid responder Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value), or glaucomatous changes in the optic nerve Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the average of the three cell counts as taken by the Konan Specular Microscope) Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.) Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Healon EndoCoat<br>Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye. | Device: Investigational Healon Endocoat<br>* Ophthalmic Viscoelastic device<br>Device: Control Healon EndoCoat<br>* Ophthalmic Viscoelastic device<br>|
| Active Comparator: Control Healon EndoCoat<br>Eligible subjects to be randomly assigned to receive investigational Healon EndoCoat in one eye and control Healon EndoCoat in fellow eye. | Device: Investigational Healon Endocoat<br>* Ophthalmic Viscoelastic device<br>Device: Control Healon EndoCoat<br>* Ophthalmic Viscoelastic device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CUMULATIVE RATE OF INTRAOCULAR PRESSURE (IOP) SPIKES 30 MMHG OR GREATER | The cumulative count and proportion of eyes with an IOP spike at 3 months will be reported by OVD. Any IOP measurements of 30 mmHg or greater are to be considered a spike. | up to 3-month follow-up | 
| MEAN PERCENT ENDOTHELIAL CELL COUNT (ECC) CHANGE PREOPERATIVELY VS. POSTOPERATIVELY | The percent change in ECC from preoperative to 3 months postoperative will be reported by descriptive statistics by OVD. | up to 3-month follow-up |