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An assessment of the surgical performance of DisCoVisc compared to Healon5 during cataract surgery with intraocular lens implantation where miotic/small pupils or intraoperative Floppy Iris Syndrome exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DisCoVisc | Active Comparator | Alcon's DisCoVisc Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery |
|
| Healon5 | Active Comparator | Abbott Medical Optic's (AMO) Healon5 Ophthalmic Viscosurgical Device (OVD) used at time of cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DisCoVisc | Device | Use of Alcon's DisCoVisc Ophthalmic Viscosurgical Device(4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery with intraocular lens implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Endothelial Cell Loss | Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| 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. Patients were randomized (Excel based schedule) based on enrollment order.
Patients were scheduled for routine, primary, bilateral cataract extraction with subsequent insertion of an intraocular lens implant and demonstrating miotic/small pupils or intraoperative floppy iris syndrome. Additionally patients were free of ocular co-morbidities that may affect results.
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| ID | Title | Description |
|---|---|---|
| FG000 | DisCoVisc | Alcon's DisCoVisc used at time of surgery |
| FG001 | Healon5 | Abbot Medical Optics (AMO) Healon5 used at time of surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DisCoVisc | Alcon's DisCoVisc used at time of surgery |
| BG001 | Healon5 | Abbot Medical Optics (AMO) Healon5 used at time of surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Endothelial cell loss/gain is measured by comparing the preoperative assessment of endothelial cell density against postoperative measurements. Measurements are made with a specular microscope, which takes a picture and numbers endothelial cells. This endpoint compares the assessment done at 1 month against the assessment done at baseline. A negative number indicates a loss of endothelial cells, a positive number indicates a gain in endothelial cells. | 14 patients/28 eyes in each group. | Posted | Mean | Standard Deviation | Percent change | 1 month |
|
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| 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's DisCoVisc used at time of surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Rogut | Alcon Research, Ltd. | 813-426-4036 | Erin.Rogut@alconlabs.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Healon5 | Device | Use of Abbott Medical Optics (AMO) Healon5 Ophthalmic Viscosurgical Device (2.3% Sodium Hyaluronate) during cataract surgery with intraocular lens implantation. |
|
| 1 Day Postoperative |
| Aqueous Signs - Cells | Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells | 1 Day Postoperative |
| Aqueous Signs - Flare | Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye.
| 1 Day Postoperative |
| Aqueous Signs - Edema | Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none
| 1 Day Postoperative |
| Surgeon Survey | Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective | Time of Surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Abbot Medical Optics (AMO) Healon5 used at time of surgery
|
|
| Secondary | Intraocular Pressure (IOP) | Intraocular Pressure (IOP) is assessed with a slit lamp by means of Applanation (Goldmann) tonometry. This type of tonometry uses a small probe to gently flatten part of your cornea to measure eye pressure. The pressure in your eye is measured by how much force is needed to flatten your cornea, and measured in millimeters of mercury (mmHg). Normally, IOP should be less than 21 mmHg. | 14 patients/28 eyes in each group. | Posted | Mean | Standard Deviation | mmHg | 1 Day Postoperative |
|
|
|
| Secondary | Aqueous Signs - Cells | Aqueous Cells are the foggy appearance given by protein that has leaked from inflamed blood vessels. This is evaluated by the surgeon one day post surgery and rated on the following scale: None, 0: 1-5 cells, 1: 6-15 cells, 2: 16-30 cells, 3: >30 cells | 14 patients/28 eyes in each group. | Posted | Mean | Standard Deviation | Units on a scale | 1 Day Postoperative |
|
|
|
| Secondary | Aqueous Signs - Flare | Aqueous Flare refers to individual inflammatory cells. Aqueous flare is evaluated by the surgeon one day after surgery and rated on the following scale: 0:No-Visible flare when compared with the normal eye.
| 14 patients/28 eyes in each group. | Posted | Mean | Standard Deviation | Units on a scale | 1 Day Postoperative |
|
|
|
| Secondary | Aqueous Signs - Edema | Aqueous signs refers cornea edema evaluated by the surgeon one day after surgery. Corneal edema is evaluated by the following scale: 0 = none
| 14 patients/28 eyes in each group. | Posted | Mean | Standard Deviation | Units on a scale | 1 Day Postoperative |
|
|
|
| Secondary | Surgeon Survey | Survey completed by the surgeon to evaluate use of the product during surgery. Responses are rated on the following scale and the means of the responses are reported: Overall surgical difficulty: 1 - very easy; 2 - easy; 3 - neither easy nor difficult; 4 - difficult; 5 - very difficult Satisfaction with performance: 1 - strongly disagree; 2 - disagree; 3 - undecided/neutral; 4 - agree; 5 - strongly agree Ability to expand pupil: 1 - not effective; 2 - moderately effective; 3 - very effective | Posted | Mean | Standard Deviation | Units on a scale | Time of Surgery |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Healon5 | Abbot Medical Optics (AMO) Healon5 used at time of surgery | 0 | 14 | 0 | 14 |
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
| Surgeon Survey: Ability to Expand Pupil |
|