Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DisCoVisc | Active Comparator | Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery. |
|
| DuoVisc | Active Comparator | Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery. |
|
| Healon5 | Active Comparator | Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery. |
|
| Amvisc Plus | Active Comparator | Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DisCoVisc | Device | Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Study Locations | Fort Worth | Texas | 76134 | United States |
During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. Group assignment was based on an Excel randomization scheme.
Subjects were >50 years old & of any race & gender. Subjects had operable cataracts in at least 1 eye, were able to provide informed consent, & were free of systemic diseases affecting ocular health, especially those affecting endothelial cell counts. Eyes were free of ocular disease & had no history of chronic/recurrent inflammatory eye disease.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DISCOVISC | DISCOVISC® Ophthalmic Viscosurgical Device (OVD) |
| FG001 | DUOVISC | DUOVISC® Viscoelastic system |
| FG002 | Healon5 | Healon5 Ophthalmic Viscosurgical Device |
| FG003 | Amvisc Plus | Amvisc Plus Ophthalmic Viscosurgical Device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DISCOVISC | DISCOVISC® Ophthalmic Viscosurgical Device (OVD) |
| BG001 | DUOVISC | DUOVISC® Viscoelastic system |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Age data not available for 2 DisCoVisc subjects, 2 Duovisc subjects, and 1 AmVisc Plus subject. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Percent Change | 1 month after surgery |
|
Not provided
There were no adverse events reported for this study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DISCOVISC | DISCOVISC® Ophthalmic Viscosurgical Device (OVD) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DuoVisc | Device | Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery. |
|
| Healon5 | Device | Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery. |
|
| Amvisc Plus | Device | Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract 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 |
| BG002 |
| Healon5 |
Healon5 Ophthalmic Viscosurgical Device |
| BG003 | Amvisc Plus | Amvisc Plus Ophthalmic Viscosurgical Device |
| BG004 | Total | Total of all reporting groups |
| Number |
| participants |
|
| Gender | Gender not available for 2 DisCoVisc subjects, 1 Duovisc subject, and 1 AmVisc Plus subject. | Number | participants |
|
Healon5 Ophthalmic Viscosurgical Device |
| OG003 | Amvisc Plus | Amvisc Plus Ophthalmic Viscosurgical Device |
|
|
| Secondary | 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. | Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus. | Posted | Mean | Standard Deviation | Percent Gain | 1 week and month after surgery |
|
|
|
| Secondary | 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. | This data was collected for all subjects attending the visit one day after surgery. | Posted | Number | Percentage of Participants | 1 day after surgery |
|
|
|
| Secondary | 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. | This data was collected for all subjects attending the visit one day after surgery. | Posted | Number | Percentage of participants | 1 Day after Surgery |
|
|
|
| Secondary | 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. | This data was collected for all subjects attending the visit one day after surgery. | Posted | Number | Percentage of participants | 1 day after surgery |
|
|
|
| Secondary | 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. | This data was collected on all subjects attending the visit one day after surgery with the exception of 3 DisCoVisc subjects, 4 DuoVisc subjects, 2 Healon5 subjects, and 1 AmVisc Plus subject. | Posted | Mean | Standard Deviation | mmHg | 1 day after surgery |
|
|
|
| Secondary | 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. | This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject. | Posted | Number | Percentage of participants | Time of surgery |
|
|
|
| Secondary | 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. | This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject. | Posted | Number | Percentage of participants | Time of Surgery |
|
|
|
| Secondary | 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. | This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject. | Posted | Number | Percentage of participants | Time of Surgery |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | DUOVISC | DUOVISC® Viscoelastic system | 0 | 29 | 0 | 29 |
| EG002 | Healon5 | Healon5 Ophthalmic Viscosurgical Device | 0 | 27 | 0 | 27 |
| EG003 | Amvisc Plus | Amvisc Plus Ophthalmic Viscosurgical Device | 0 | 27 | 0 | 27 |
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
| Before Surgery to 1 Month after Surgery |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Grade 1 |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Shallow |
|
| Working Space Adequate |
|
| Full Chamber Maintenance |
|
| Shallow |
|
| Working Space Adequate |
|
| Full Chamber Maintenance |
|
| Shallow |
|
| Working Space Adequate |
|
| Full Chamber Maintenance |
|