DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Study Overview
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Brief Summary
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A comparison of the ability of DisCoVisc to that of other ophthalmic viscosurgical devices (OVDs) (DuoVisc, Healon5 or Amvisc PLUS) regarding endothelial protection and anterior chamber space maintenance during non-eventful cataract surgery.

Official Title
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DisCoVisc Versus Competitor

Conditions
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Cataract

Intervention / Treatment
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* Device: DisCoVisc
* Device: DuoVisc
* Device: Healon5
* Device: Amvisc Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: operable cataracts in at least one eye Exclusion Criteria: Endothelial Cell Count (ECC) ≤1500cells/mm2 Intraocular Pressure (IOP) > 21mm Hg previous ocular inflammation systemic or ocular conditions affecting corneal endothelium

Ages Eligible for Study
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Minimum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DisCoVisc<br>Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery. | Device: DisCoVisc<br>* Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.<br>|
| Active Comparator: DuoVisc<br>Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery. | Device: DuoVisc<br>* Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.<br>|
| Active Comparator: Healon5<br>Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery. | Device: Healon5<br>* Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.<br>|
| Active Comparator: Amvisc Plus<br>Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery. | Device: Amvisc Plus<br>* Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Endothelial Cell Loss | Percentage of corneal endothelial cells lost 1 month after surgery as compared to the number of corneal endothelial cells measured before surgery. Corneal endothelial cells are measured by counting the number of cells on an image taken by specular microscope. | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Gain in Corneal Thickness. | Percent Gain in Corneal Thickness between the assessment performed before surgery to that performed after surgery. This was assessed at both the 1 week and 1 month visit. Corneal thickness is measured in micrometers and is evaluated by Pachymetry. A negative number indicates a decrease in corneal thickness. | 1 week and month after surgery | 
| Aqueous Signs - Corneal Edema | Measured as the percentage of patient's eyes subjectively evaluated to have corneal edema at each of the following gradings: 0 - none; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema. | 1 day after surgery | 
| Aqueous Signs - Aqueous Flare | Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Flare at each of the following gradings: 0 - None: No visible flare when compared to the normal eye, 1 - Mild: Flare visible against dark papillary background but not visible against iris background, 2 - Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as teh dark papillary background, 3 - Severe: Very dense flare. May also present as a hazy appearance of anterior segment structures when viewed with low power magnification of the slit-lamp. | 1 Day after Surgery | 
| Aqueous Signs - Aqueous Cells | Measured as the percentage of patient's eyes subjectively evaluated to have Aqueous Cells at each of the following gradings: 0 - None, 1 - 1 to 5 cells, 2 - 6 to 15 cells, 3 - 16 - 30 cells, 4 - >30 cells. | 1 day after surgery | 
| Intraocular Pressure (IOP) | Measure of intraocular pressure of a patient's eye via tonometry one day after surgery. Measured in mmHg. Normal intraocular pressure is between 10 mmHg and 20 mmHg. | 1 day after surgery | 
| Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during anterior capsulotomy. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance. | Time of surgery | 
| Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification | Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during phacoemulsification. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance. | Time of Surgery | 
| Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion | Surgeon reporting of Anterior Chamber Dome Maintenance of a subject's eye during intraocular lens (IOL) insertion. Evaluated on a subjective scale and reported as percent by response. The following scale is used, from worst to best: Flat, Shallow, Working Space Adequate, Full Chamber Maintenance. | Time of Surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Discovisc, Ophthalmic Viscosurgical Device