To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Study Overview
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Brief Summary
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The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

Official Title
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To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

Conditions
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Cataract

Intervention / Treatment
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* Device: DisCoVisc®
* Drug: Healon
* Drug: Amvisc Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients able to understand and sign a document of informed consent; Patients aged ≥49 years with age-related cataract formation; Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens; Patients that have healthy eyes excluding the formation of cataract. Exclusion Criteria: pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye; A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye; Iris atrophy in the operative eye; Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye; Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye; Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam; Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement; Baseline endothelial cell density < 1500 cells/mm2, in the operative eye; Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy Patients 48 years of age or younger; Proliferative diabetic retinopathy in the operative eye; Uncontrolled diabetes mellitus; Marfan's Syndrome; An ocular disease and/or condition that may compromise results; A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye; Lens for the correction of astigmatism may be performed; Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion; A non-functional fellow eye; Participation in any other clinical study within the 30 days before surgery

Ages Eligible for Study
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Minimum Age: 49 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DisCoVisc®<br>DisCoVisc® Ophthalmic Viscosurgical Device | Device: DisCoVisc®<br>* Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure<br>|
| Active Comparator: Healon<br>Healon | Drug: Healon<br>* Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure<br>|
| Active Comparator: Amvisc Plus<br>Amvisc Plus | Drug: Amvisc Plus<br>* Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Count Change From Baseline | Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium. | one month | 
| Investigator Reported Space Maintenance | Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: Full Chamber Maintained, Working Space Maintained, Shallow, Flat. Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion. | During surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corneal Thickness | Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry. | 1 month | 
| Corneal Clarity | Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract