DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00712244
Collaborator
(none)
112
Enrollment
1
Location
4
Arms

Study Details

Study Description

Brief Summary

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: DisCoVisc
  • Device: DuoVisc
  • Device: Healon5
  • Device: Amvisc Plus
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
DisCoVisc Versus Competitor
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Apr 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: DisCoVisc

Use of DisCoVisc Ophthalmic Viscosurgical Device during cataract surgery.

Device: DisCoVisc
Use of DisCoVisc Ophthalmic Viscosurgical Device (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) during cataract surgery.

Active Comparator: DuoVisc

Use of DuoVisc Viscoelastic System (Viscoat, Provisc) during cataract surgery.

Device: DuoVisc
Use of DuoVisc viscoelastic system consisting of Viscoat (3% sodium hyaluronate, 4% chondroitin sulfate)and Provisc(1% sodium hyaluronate) during cataract surgery.

Active Comparator: Healon5

Use of Healon5 ophthalmic viscosurgical device (OVD) during cataract surgery.

Device: Healon5
Use of Healon5 ophthalmic viscosurgical device (2.3% Sodium Hyaluronate) during cataract surgery.

Active Comparator: Amvisc Plus

Use of Amvisc Plus ophthalmic viscosurgical device during cataract surgery.

Device: Amvisc Plus
Use of Amvisc Plus ophthalmic viscosurgical device (1.6% Sodium Hyaluronate) during cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. Corneal Endothelial Cell Loss [1 month after surgery]

    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.

Secondary Outcome Measures

  1. Percent Gain in Corneal Thickness. [1 week and month after surgery]

    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.

  2. 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; 1 - Mild, slight localized or generalized edema; 2 - Moderate, significant localized or generalized edema; 3 - Severe, advanced localized or generalized edema.

  3. Aqueous Signs - Aqueous Flare [1 Day after 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 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.

  4. Aqueous Signs - Aqueous Cells [1 day after surgery]

    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.

  5. Intraocular Pressure (IOP) [1 day after surgery]

    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.

  6. Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy [Time of surgery]

    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.

  7. Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification [Time of Surgery]

    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.

  8. Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion [Time of Surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • operable cataracts in at least one eye
Exclusion Criteria:
  • Endothelial Cell Count (ECC) ≤1500cells/mm2

  • Intraocular Pressure (IOP) > 21mm Hg

  • previous ocular inflammation

  • systemic or ocular conditions affecting corneal endothelium

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Contact Alcon Call Center for Study LocationsFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00712244
Other Study ID Numbers:
  • M07-014
First Posted:
Jul 9, 2008
Last Update Posted:
Sep 14, 2010
Last Verified:
Sep 1, 2010
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsSubjects 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.
Pre-assignment DetailDuring 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.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Period Title: Overall Study
STARTED29292727
COMPLETED25282526
NOT COMPLETED4121

Baseline Characteristics

Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc PlusTotal
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical DeviceTotal of all reporting groups
Overall Participants29292727112
Age (participants) [Number]
<=18 years
0
0%
0
0%
0
0%
0
0%
0
0%
Between 18 and 65 years
12
41.4%
12
41.4%
9
33.3%
8
29.6%
41
36.6%
>=65 years
16
55.2%
15
51.7%
18
66.7%
18
66.7%
67
59.8%
Gender (participants) [Number]
Female
18
62.1%
15
51.7%
16
59.3%
19
70.4%
68
60.7%
Male
10
34.5%
12
41.4%
11
40.7%
7
25.9%
40
35.7%

Outcome Measures

1. Primary Outcome
TitleCorneal Endothelial Cell Loss
DescriptionPercentage 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.
Time Frame1 month after surgery

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants24262425
Mean (Standard Deviation) [Percent Change]
1.51
(5.99)
1.18
(11.18)
4.72
(7.23)
6.30
(14.31)
2. Secondary Outcome
TitlePercent Gain in Corneal Thickness.
DescriptionPercent 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.
Time Frame1 week and month after surgery

Outcome Measure Data

Analysis Population Description
Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants25282526
Before Surgery to 1 Week after Surgery
2.89
(16.45)
7.02
(12.06)
9.92
(15.29)
5.06
(12.07)
Before Surgery to 1 Month after Surgery
-0.55
(11.79)
-1.06
(25.38)
1.98
(10.57)
-9.11
(22.85)
3. Secondary Outcome
TitleAqueous Signs - Corneal Edema
DescriptionMeasured 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.
Time Frame1 day after surgery

Outcome Measure Data

Analysis Population Description
This data was collected for all subjects attending the visit one day after surgery.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282626
None
68.97
237.8%
75
258.6%
57.69
213.7%
65.38
242.1%
Mild
57.59
198.6%
21.43
73.9%
34.62
128.2%
34.62
128.2%
Moderate
3.45
11.9%
3.57
12.3%
7.69
28.5%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
4. Secondary Outcome
TitleAqueous Signs - Aqueous Flare
DescriptionMeasured 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.
Time Frame1 Day after Surgery

Outcome Measure Data

Analysis Population Description
This data was collected for all subjects attending the visit one day after surgery.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282626
None
20.69
71.3%
39.29
135.5%
26.92
99.7%
46.15
170.9%
Mild
75.86
261.6%
53.57
184.7%
65.38
242.1%
53.85
199.4%
Moderate
3.45
11.9%
7.14
24.6%
7.69
28.5%
0
0%
Severe
0
0%
0
0%
0
0%
0
0%
5. Secondary Outcome
TitleAqueous Signs - Aqueous Cells
DescriptionMeasured 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.
Time Frame1 day after surgery

Outcome Measure Data

Analysis Population Description
This data was collected for all subjects attending the visit one day after surgery.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282626
Grade 0
6.9
23.8%
14.29
49.3%
7.69
28.5%
7.69
28.5%
Grade 1
65.52
225.9%
46.43
160.1%
50
185.2%
65.38
242.1%
Grade 2
24.14
83.2%
32.14
110.8%
38.46
142.4%
23.08
85.5%
Grade 3
3.45
11.9%
7.14
24.6%
3.85
14.3%
3.85
14.3%
Grade 4
0
0%
0
0%
0
0%
0
0%
6. Secondary Outcome
TitleIntraocular Pressure (IOP)
DescriptionMeasure 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.
Time Frame1 day after surgery

Outcome Measure Data

Analysis Population Description
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.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants26252526
Mean (Standard Deviation) [mmHg]
21.58
(8.42)
19.48
(4.6)
20.72
(6.61)
18.65
(5.56)
7. Secondary Outcome
TitleSurgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
DescriptionSurgeon 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 FrameTime of surgery

Outcome Measure Data

Analysis Population Description
This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282727
Flat
0
0%
0
0%
0
0%
0
0%
Shallow
3.45
11.9%
3.57
12.3%
22.22
82.3%
18.52
68.6%
Working Space Adequate
0
0%
7.14
24.6%
48.15
178.3%
55.56
205.8%
Full Chamber Maintenance
96.55
332.9%
89.29
307.9%
29.63
109.7%
25.93
96%
8. Secondary Outcome
TitleSurgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
DescriptionSurgeon 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 FrameTime of Surgery

Outcome Measure Data

Analysis Population Description
This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282727
Flat
0
0%
0
0%
0
0%
0
0%
Shallow
0
0%
0
0%
11.11
41.1%
3.7
13.7%
Working Space Adequate
0
0%
3.57
12.3%
51.85
192%
48.15
178.3%
Full Chamber Maintenance
100
344.8%
96.43
332.5%
37.04
137.2%
48.15
178.3%
9. Secondary Outcome
TitleSurgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
DescriptionSurgeon 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 FrameTime of Surgery

Outcome Measure Data

Analysis Population Description
This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
Measure Participants29282727
Flat
0
0%
0
0%
0
0%
0
0%
Shallow
0
0%
0
0%
40.74
150.9%
7.41
27.4%
Working Space Adequate
0
0%
7.14
24.6%
25.93
96%
44.44
164.6%
Full Chamber Maintenance
100
344.8%
92.86
320.2%
33.33
123.4%
48.15
178.3%

Adverse Events

Time Frame
Adverse Event Reporting Description There were no adverse events reported for this study.
Arm/Group TitleDISCOVISCDUOVISCHealon5Amvisc Plus
Arm/Group DescriptionDISCOVISC® Ophthalmic Viscosurgical Device (OVD)DUOVISC® Viscoelastic systemHealon5 Ophthalmic Viscosurgical DeviceAmvisc Plus Ophthalmic Viscosurgical Device
All Cause Mortality
DISCOVISCDUOVISCHealon5Amvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
DISCOVISCDUOVISCHealon5Amvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/29 (0%) 0/29 (0%) 0/27 (0%) 0/27 (0%)
Other (Not Including Serious) Adverse Events
DISCOVISCDUOVISCHealon5Amvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/29 (0%) 0/29 (0%) 0/27 (0%) 0/27 (0%)

Limitations/Caveats

[Not Specified]

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/TitleAlcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00712244
Other Study ID Numbers:
  • M07-014
First Posted:
Jul 9, 2008
Last Update Posted:
Sep 14, 2010
Last Verified:
Sep 1, 2010