DisCoVisc Comparative Evaluation

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

Official Title
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A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

Conditions
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Cataracts

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral operable cataracts Exclusion Criteria: Preoperative Endothelial Cell Count (ECC) ≤1500 cells/mm2 Intraocular Pressure (IOP) > 21 History of ocular inflammation Systemic or ocular diseases affecting corneal endothelium

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DisCoVisc<br>Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Device: DisCoVisc<br>* DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.<br>|
| Active Comparator: DuoVisc<br>Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Device: DuoVisc<br>* DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.<br>|
| Active Comparator: BioVisc<br>Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | Device: BioVisc<br>* BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.<br>|
| Active Comparator: Healon5<br>AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Device: Healon5<br>* Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.<br>|
| Active Comparator: Amvisc Plus<br>Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) | Device: Amvisc Plus<br>* Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Loss of Endothelial Cells | Percentage of corneal endothelial cells lost 2 months after surgery as compared to the number of corneal endothelial cells measured before the operation. Corneal Endothelial Cells are measured by counting the number of cells on an image taken by specular microscope. | 2 months following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 - Mild, slight localized or generalized edema - Moderate, significant localized or generalized edema - 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 with the normal eye. Mild: Flare visible against dark papillary background but not visible against iris background. Moderate: Flare is visible with the slit-lamp beam aimed onto the iris surface as well as the dark papillary background. 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 following 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 to 5 cells - 6 to 15 cells - 16 to 30 cells - >30 cells | 1 day following 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 between 10 mmHg and 20 mmHg. | 1 day following surgery | 
| Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Surgeon reporting of Anterior Chamber Dome Maintenance of a patient'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 | 
| Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Surgeon reporting of Anterior Chamber Dome Maintenance of a patient'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 | 
| Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Surgeon reporting of Anterior Chamber Dome Maintenance During Intraocular Lens (IOL) insertion into a patient's eye. Evaluated on a subjective scale and reported as percent by response. The scale, from worst to best, is as follows: 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 OVD, Ophthalmic Viscosurgical Device