I-ZIP Ocular Bandage Pivotal Study

Study Overview
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Brief Summary
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To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.

Official Title
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Clinical Evaluation of the I-ZIP® Ocular Bandage as a Protective Ocular Bandage in Subjects Undergoing Clear Corneal Cataract Surgery With IOL Implantation: A Pivotal Study

Conditions
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Cataract

Intervention / Treatment
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* Device: I-ZIP Ocular Bandage
* Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation using internal calipers. Exclusion Criteria: Any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative NRPS Previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/IOL implantation surgery Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations Subject is currently receiving antineoplastic therapy Use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery. Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR), proliferative diabetic retinopathy (PDR) or compromised macular function

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-ZIP Ocular Bandage<br>I-Zip bandage application | Device: I-ZIP Ocular Bandage<br> <br> |
| Active Comparator: Oasis 24 hour Soft Shield Collagen Corneal Shield<br>Oasis shield application | Device: Oasis 24 Hour Soft Shield Collagen Corneal Shield<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device remains localized over corneal incision |  | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse ocular events |  | 30 days post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract or intraocular lens placement surgery