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 Opthalmic Viscosurgical Devices (OVDs) (DuoVisc®, BioVisc®, 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 | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
|
| DuoVisc | Active Comparator | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) |
|
| BioVisc | Active Comparator | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
|
| Healon5 | Active Comparator | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
|
| Amvisc Plus | Active Comparator | Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DisCoVisc | Device | DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
| 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 |
| 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
| 1 day 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 |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
As access to Ophthalmic Viscosurgical Devices (OVDs) was limited, patients received whichever OVD was in stock at the time of surgery. 51 patients had a different OVD used in each eye. As a result, their demographic data is included in 2 OVD groups, resulting in a total of 224 patients (when group totals are added).
Preoperatively, subjects were examined to ensure they met the inclusion/exclusion criteria. Patients were >49 years of age, of any race and either gender. Patients had operable cataracts in at least one eye and were able to provide informed consent
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DisCoVisc | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
| FG001 | DuoVisc | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) |
| FG002 | BioVisc | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
| FG003 | Healon5 | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
| FG004 | AmviscPlus | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DisCoVisc | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
| BG001 | DuoVisc | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age not available for the following: 7 Discovisc patients, 11 Duovisc patients, 3 Biovisc patients, 4 Amvisc Plus patients. Total mean age and standard deviation not calculated. |
| 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 | 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. | This data was collected on the eyes of patients attending the visit 2 months after surgery. | Posted | Mean | Standard Deviation | Percent Loss | 2 months following surgery |
|
Not provided
Adverse events collected against the total number of eyes that could be affected instead of patients.
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 | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
Not provided
Not provided
At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).
| 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 | 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. |
|
| BioVisc | Device | BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
|
| Healon5 | Device | Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
|
| Amvisc Plus | Device | Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure. |
|
| 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.
| 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 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 |
| BG002 | BioVisc | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
| BG003 | Healon5 | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
| BG004 | AmviscPlus | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| BG005 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Gender | Gender not available for the following: 2 Discovisc patients, 2 Duovisc patients, 1 Biovisc patient, 2 Amvisc Plus patients. | Number | participants |
|
| OG002 | BioVisc | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
| OG003 | Healon5 | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
| OG004 | AmviscPlus | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
|
|
| 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
| This data was collected on all eyes of patients attending the 1-day visit. | Posted | Number | Percentage of Eyes | 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 with the normal eye.
| This data was collected on all eyes of patients attending the 1 day postoperative visit. | Posted | Number | Percentage of Eyes | 1 day following 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
| This data was collected on all eyes of patients attending the 1 day post-operative visit. | Posted | Number | Percentage of Eyes | 1 day following 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 between 10 mmHg and 20 mmHg. | This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients. | Posted | Mean | Standard Deviation | mmHg | 1 day following surgery |
|
|
|
| Secondary | 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. | This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes | Posted | Number | Percentage of Eyes | Time of Surgery |
|
|
|
| Secondary | 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 | This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes. | Posted | Number | Percentage of Eyes | Time of Surgery |
|
|
|
| Secondary | 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 | This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes. | Posted | Number | Percentage of Eyes | Time of Surgery |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | DuoVisc | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | 0 | 41 | 0 | 41 |
| EG002 | BioVisc | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | 0 | 26 | 0 | 26 |
| EG003 | Healon5 | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | 0 | 33 | 0 | 33 |
| EG004 | AmviscPlus | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) | 0 | 55 | 0 | 55 |
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
| 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 Chamber Adequate |
|
| Full Chamber Maintenance |
|