DisCoVisc Comparative Evaluation
Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00732225
Collaborator
(none)
173
1
5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
173 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery
Study Start Date
:
May 1, 2007
Actual Primary Completion Date
:
Feb 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: DisCoVisc Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) |
Device: DisCoVisc
DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
|
| Active Comparator: DuoVisc Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) |
Device: DuoVisc
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.
|
| Active Comparator: BioVisc Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) |
Device: BioVisc
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
|
| Active Comparator: Healon5 AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) |
Device: Healon5
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
|
| Active Comparator: Amvisc Plus Bausch & Lomb Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
Device: Amvisc Plus
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
|
Outcome Measures
Primary Outcome Measures
- Percent Loss of Endothelial Cells [2 months following surgery]
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.
Secondary Outcome Measures
- Aqueous Signs - Corneal Edema [1 day after surgery]
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
- Aqueous Signs - Aqueous Flare [1 day following surgery]
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.
- Aqueous Signs - Aqueous Cells [1 day following surgery]
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
- Intraocular Pressure (IOP) [1 day following surgery]
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.
- Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy [Time of Surgery]
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.
- Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification [Time of Surgery]
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
- Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion [Time of Surgery]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
49 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00732225
Other Study ID Numbers:
- M07-015
First Posted:
Aug 11, 2008
Last Update Posted:
Jul 30, 2010
Last Verified:
Jun 1, 2010
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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 |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Period Title: Overall Study | |||||
| STARTED | 71 | 40 | 26 | 33 | 54 |
| COMPLETED | 60 | 32 | 23 | 29 | 48 |
| NOT COMPLETED | 11 | 8 | 3 | 4 | 6 |
Baseline Characteristics
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) | Total of all reporting groups |
| Overall Participants | 71 | 40 | 26 | 33 | 54 | 224 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
66.8
(9.54)
|
67.31
(12.61)
|
71.48
(8.56)
|
67.03
(12.13)
|
66.24
(10.51)
|
67.9
(10.8)
|
| Gender (participants) [Number] | ||||||
| Female |
42
59.2%
|
22
55%
|
13
50%
|
19
57.6%
|
29
53.7%
|
125
55.8%
|
| Male |
27
38%
|
16
40%
|
12
46.2%
|
14
42.4%
|
23
42.6%
|
92
41.1%
|
Outcome Measures
| Title | Percent Loss of Endothelial Cells |
|---|---|
| Description | 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. |
| Time Frame | 2 months following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| This data was collected on the eyes of patients attending the visit 2 months after surgery. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 64 | 32 | 23 | 29 | 46 |
| Mean (Standard Deviation) [Percent Loss] |
9.48
(20.72)
|
15.66
(11.03)
|
23.69
(13.47)
|
25.70
(13.94)
|
23.04
(16.20)
|
| Title | Aqueous Signs - Corneal Edema |
|---|---|
| Description | 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 |
| Time Frame | 1 day after surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| This data was collected on all eyes of patients attending the 1-day visit. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 75 | 41 | 24 | 33 | 55 |
| None |
81.33
|
78.05
|
37.50
|
63.64
|
54.55
|
| Mild |
14.67
|
19.51
|
37.50
|
30.30
|
32.73
|
| Moderate |
4.00
|
2.44
|
25.00
|
6.06
|
12.73
|
| Severe |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Title | Aqueous Signs - Aqueous Flare |
|---|---|
| Description | 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. |
| Time Frame | 1 day following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| This data was collected on all eyes of patients attending the 1 day postoperative visit. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 75 | 41 | 24 | 33 | 55 |
| None |
76.00
|
75.61
|
41.67
|
63.64
|
54.55
|
| Mild |
21.33
|
19.51
|
33.33
|
24.24
|
34.55
|
| Moderate |
2.67
|
4.88
|
25.00
|
12.12
|
10.91
|
| Severe |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Title | Aqueous Signs - Aqueous Cells |
|---|---|
| Description | 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 |
| Time Frame | 1 day following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| This data was collected on all eyes of patients attending the 1 day post-operative visit. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 75 | 41 | 24 | 33 | 55 |
| Grade 0 |
84.00
|
80.49
|
45.83
|
63.64
|
56.36
|
| Grade 1 |
16.00
|
17.07
|
25.00
|
27.27
|
36.36
|
| Grade 2 |
0.00
|
2.44
|
29.17
|
9.09
|
7.27
|
| Grade 3 |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Grade 4 |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Title | Intraocular Pressure (IOP) |
|---|---|
| Description | 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. |
| Time Frame | 1 day following surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 72 | 37 | 25 | 32 | 51 |
| Mean (Standard Deviation) [mmHg] |
17.67
(3.88)
|
17.78
(3.81)
|
20.32
(7.39)
|
19.88
(8.90)
|
16.96
(4.76)
|
| Title | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy |
|---|---|
| Description | 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 Frame | Time of Surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 74 | 41 | 25 | 33 | 55 |
| Flat |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Shallow |
2.70
|
0.00
|
100.00
|
9.09
|
85.45
|
| Working Space Adequate |
13.51
|
0.00
|
0.00
|
0.00
|
3.64
|
| Full Chamber Maintenance |
83.78
|
100.00
|
0.00
|
90.91
|
10.91
|
| Title | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification |
|---|---|
| Description | 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 Frame | Time of Surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 59 | 22 | 20 | 30 | 42 |
| Flat |
0.00
|
0.0
|
0.00
|
0.00
|
0.00
|
| Shallow |
0.00
|
0.00
|
25.00
|
0.00
|
2.38
|
| Working Space Adequate |
10.17
|
9.09
|
70.00
|
36.67
|
80.95
|
| Full Chamber Maintenance |
89.83
|
90.91
|
5.00
|
63.33
|
16.67
|
| Title | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion |
|---|---|
| Description | 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 Frame | Time of Surgery |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) |
| Measure Participants | 59 | 21 | 20 | 29 | 41 |
| Flat |
0.00
|
0.00
|
0.00
|
0.00
|
0.00
|
| Shallow |
0.00
|
0.00
|
10.00
|
0.00
|
4.88
|
| Working Chamber Adequate |
3.39
|
9.52
|
90.00
|
24.14
|
68.29
|
| Full Chamber Maintenance |
96.61
|
90.48
|
0.00
|
75.86
|
26.83
|
Adverse Events
| Time Frame | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events collected against the total number of eyes that could be affected instead of patients. | |||||||||
| Arm/Group Title | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus | |||||
| Arm/Group Description | Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) | |||||
All Cause Mortality |
||||||||||
| DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/41 (0%) | 0/26 (0%) | 0/33 (0%) | 0/55 (0%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/76 (0%) | 0/41 (0%) | 0/26 (0%) | 0/33 (0%) | 0/55 (0%) | |||||
Limitations/Caveats
At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
Results Point of Contact
| Name/Title | Alcon Clinical |
|---|---|
| Organization | Alcon Research, Ltd. |
| Phone | 888.451.3937; 817.568.6725 |
| medinfo@alconlabs.com |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00732225
Other Study ID Numbers:
- M07-015
First Posted:
Aug 11, 2008
Last Update Posted:
Jul 30, 2010
Last Verified:
Jun 1, 2010