To Compare the Ability of DiscoVisc® OVD to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
Study Details
Study Description
Brief Summary
The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DisCoVisc® DisCoVisc® Ophthalmic Viscosurgical Device |
Device: DisCoVisc®
Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure
|
Active Comparator: Healon Healon |
Drug: Healon
Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure
|
Active Comparator: Amvisc Plus Amvisc Plus |
Drug: Amvisc Plus
Injection of Amvisc Plus into the anterior chamber prior to and throughout the cataract surgery procedure
|
Outcome Measures
Primary Outcome Measures
- Endothelial Cell Count Change From Baseline [one month]
Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
- Investigator Reported Space Maintenance [During surgical procedure]
Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion.
Secondary Outcome Measures
- Change in Corneal Thickness [1 month]
Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
- Corneal Clarity [2 weeks]
Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients able to understand and sign a document of informed consent;
-
Patients aged ≥49 years with age-related cataract formation;
-
Patients planning to undergo surgical removal of cataract by phacoemulsification with implantation of a posterior chamber intraocular lens;
-
Patients that have healthy eyes excluding the formation of cataract.
Exclusion Criteria:
-
pseudoexfoliation syndrome with glaucoma or zonular compromise in the operative eye;
-
A congenital ocular anomaly (e.g., aniridia, congenital cataract) in the operative eye;
-
Iris atrophy in the operative eye;
-
Glaucoma (including pseudoexfoliation or pigmentary) or any causes of compromised outflow in the operative eye;
-
Any abnormality which prevents reliable Goldmann applanation tonometry in the operative eye;
-
Ocular hypertension (lntraocular Pressure (IOP) > 21 mmHg) in the operative eye at the baseline exam;
-
Corneal abnormality that results in a poor endothelial cell photograph and prevents reliable endothelial cell density measurement;
-
Baseline endothelial cell density < 1500 cells/mm2, in the operative eye;
-
Planned multiple procedures during cataract/Intraocular Lens (IOL) implantation surgery (e.g., trabeculoplasty, corneal transplant). NOTE: A minor relaxing keratotomy
-
Patients 48 years of age or younger;
-
Proliferative diabetic retinopathy in the operative eye;
-
Uncontrolled diabetes mellitus;
-
Marfan's Syndrome;
-
An ocular disease and/or condition that may compromise results;
-
A history of chronic or recurrent inflammatory eye disease (e.g. iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis) in the operative eye;
-
Lens for the correction of astigmatism may be performed;
-
Previous ocular trauma to the operative eye (this includes previous intraocular surgery and traumatic cataract). NOTE: history of non-invasive laser surgery (with the exception of laser treatment for PDR) is acceptable for inclusion;
-
A non-functional fellow eye;
-
Participation in any other clinical study within the 30 days before surgery
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Call Center | 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.- AUS-S-07-01
Study Results
Participant Flow
Recruitment Details | Patients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010 |
---|---|
Pre-assignment Detail | Patients were screened prior to cataract operation |
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus |
---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus |
Period Title: Overall Study | |||
STARTED | 61 | 60 | 63 |
COMPLETED | 61 | 58 | 63 |
NOT COMPLETED | 0 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus | Total |
---|---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus | Total of all reporting groups |
Overall Participants | 61 | 60 | 63 | 184 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
73.97
(9.03)
|
75.56
(7.6)
|
75.51
(8.49)
|
75.01
(8.39)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
34
55.7%
|
40
66.7%
|
43
68.3%
|
117
63.6%
|
Male |
27
44.3%
|
20
33.3%
|
20
31.7%
|
67
36.4%
|
Outcome Measures
Title | Endothelial Cell Count Change From Baseline |
---|---|
Description | Change in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium. |
Time Frame | one month |
Outcome Measure Data
Analysis Population Description |
---|
Only those participants that had endothelial cell counts at both baseline and follow-up were included in this analysis. |
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus |
---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus |
Measure Participants | 57 | 58 | 61 |
Mean (Standard Deviation) [Percent change from baseline] |
-7.91
(16.49)
|
-5.11
(19.41)
|
-4.92
(13.89)
|
Title | Investigator Reported Space Maintenance |
---|---|
Description | Maintenance of the anterior chamber/dome during cataract surgery. This was rated by the surgeon in one of 4 categories: "Full Chamber Maintained", "Working Space Maintained", "Shallow", "Flat". Space maintenance was reported during Capsulorhexis, Hydrodissection, Phacoemulsification, and IOL insertion. |
Time Frame | During surgical procedure |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus |
---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus |
Measure Participants | 61 | 58 | 61 |
Capsulorhexis - full chamber maintained |
59
96.7%
|
26
43.3%
|
61
96.8%
|
Capsulorhexis - working space maintained |
2
3.3%
|
26
43.3%
|
1
1.6%
|
Capsulorhexis - shallow |
0
0%
|
5
8.3%
|
1
1.6%
|
Capsulorhexis - flat |
0
0%
|
1
1.7%
|
0
0%
|
Hydrodissection - full chamber maintained |
52
85.2%
|
10
16.7%
|
45
71.4%
|
Hydrodissection - working space maintained |
8
13.1%
|
22
36.7%
|
10
15.9%
|
Hydrodissection - shallow |
1
1.6%
|
16
26.7%
|
6
9.5%
|
Hydrodissection - flat |
0
0%
|
10
16.7%
|
2
3.2%
|
Phacoemulsification - full chamber maintained |
59
96.7%
|
55
91.7%
|
62
98.4%
|
Phacoemulsification - working space maintained |
2
3.3%
|
3
5%
|
1
1.6%
|
Phacoemulsification - shallow |
0
0%
|
0
0%
|
0
0%
|
Phacoemulsification - flat |
0
0%
|
0
0%
|
0
0%
|
IOL insertion - full chamber maintained |
59
96.7%
|
48
80%
|
63
100%
|
IOL insertion - working space maintained |
2
3.3%
|
8
13.3%
|
0
0%
|
IOL insertion - shallow |
0
0%
|
1
1.7%
|
0
0%
|
IOL insertion - flat |
0
0%
|
1
1.7%
|
0
0%
|
Title | Change in Corneal Thickness |
---|---|
Description | Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry. |
Time Frame | 1 month |
Outcome Measure Data
Analysis Population Description |
---|
Subjects that did not have both baseline and 1 month values were not included in this analysis. |
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus |
---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus |
Measure Participants | 57 | 57 | 61 |
Median (Standard Deviation) [millimeters] |
0.53
(0.04)
|
0.54
(0.04)
|
0.53
(0.04)
|
Title | Corneal Clarity |
---|---|
Description | Evaluation of corneal clarity as assessed by levels of aqueous flare and aqueous cells. Evaluations were based on the surgeons judgement and graded on a scale. Aqueous flare was graded on the following scale: No visible flare, mild, moderate, severe. Aqueous cells were graded on the following scale: no cells, 1-20 cells, 10-50 cells, too many cells to count, cells frozen. |
Time Frame | 2 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Data from subjects for whom this evaluation was not performed is not included in this analysis. |
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus |
---|---|---|---|
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus |
Measure Participants | 61 | 58 | 63 |
Aqueous flare - no visible flare |
2
|
2
|
1
|
Aqueous flare - mild |
53
|
54
|
59
|
Aqueous flare - moderate |
6
|
4
|
3
|
Aqueous flare - severe |
0
|
0
|
0
|
Aqueous cells - no cells |
0
|
0
|
0
|
Aqueous cells - 1-10 cells |
10
|
8
|
11
|
Aqueous cells - 10-50 cells |
34
|
37
|
37
|
Aqueous cells - too many cells to count |
16
|
15
|
15
|
Aqueous cells - cells frozen |
0
|
0
|
0
|
Adverse Events
Time Frame | 1 month | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | All adverse events were recorded by Principal Investigator. | |||||
Arm/Group Title | DisCoVisc® | Healon | Amvisc Plus | |||
Arm/Group Description | DisCoVisc® Ophthalmic Viscosurgical Device | Healon | Amvisc Plus | |||
All Cause Mortality |
||||||
DisCoVisc® | Healon | Amvisc Plus | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
DisCoVisc® | Healon | Amvisc Plus | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/61 (0%) | 0/60 (0%) | 0/63 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
DisCoVisc® | Healon | Amvisc Plus | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/61 (0%) | 0/60 (0%) | 0/63 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Director of Alcon Clinical |
---|---|
Organization | Alcon Research, Ltd. |
Phone | 888.451.3937; 817.568.6725 |
medinfo@alconlabs.com |
- AUS-S-07-01