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.

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT00763360
Collaborator
(none)
184
Enrollment
1
Location
3
Arms

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 DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
184 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.
Study Start Date :
May 1, 2008
Actual Primary Completion Date :
Sep 1, 2010

Arms and Interventions

ArmIntervention/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

  1. 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.

  2. 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

  1. Change in Corneal Thickness [1 month]

    Change in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.

  2. 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

Ages Eligible for Study:
49 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

SiteCityStateCountryPostal Code
1Alcon Call CenterFort WorthTexasUnited States76134

Sponsors and Collaborators

  • Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763360
Other Study ID Numbers:
  • AUS-S-07-01
First Posted:
Sep 30, 2008
Last Update Posted:
Jan 24, 2012
Last Verified:
Dec 1, 2011
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsPatients were undergoing a cataract operation and were recruited from surgery during 2008 to 2010
Pre-assignment DetailPatients were screened prior to cataract operation
Arm/Group TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
Period Title: Overall Study
STARTED616063
COMPLETED615863
NOT COMPLETED020

Baseline Characteristics

Arm/Group TitleDisCoVisc®HealonAmvisc PlusTotal
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc PlusTotal of all reporting groups
Overall Participants616063184
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

1. Primary Outcome
TitleEndothelial Cell Count Change From Baseline
DescriptionChange in endothelial cell count compared to baseline. Endothelial cell count peformed by counting of cells on photographic image of endothelium.
Time Frameone 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 TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
Measure Participants575861
Mean (Standard Deviation) [Percent change from baseline]
-7.91
(16.49)
-5.11
(19.41)
-4.92
(13.89)
2. Primary Outcome
TitleInvestigator Reported Space Maintenance
DescriptionMaintenance 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 FrameDuring surgical procedure

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
Measure Participants615861
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%
3. Secondary Outcome
TitleChange in Corneal Thickness
DescriptionChange in corneal thickness from baseline, measured in millimeters. Measurement performed by pachymetry.
Time Frame1 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 TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
Measure Participants575761
Median (Standard Deviation) [millimeters]
0.53
(0.04)
0.54
(0.04)
0.53
(0.04)
4. Secondary Outcome
TitleCorneal Clarity
DescriptionEvaluation 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 Frame2 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 TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
Measure Participants615863
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 Frame1 month
Adverse Event Reporting Description All adverse events were recorded by Principal Investigator.
Arm/Group TitleDisCoVisc®HealonAmvisc Plus
Arm/Group DescriptionDisCoVisc® Ophthalmic Viscosurgical DeviceHealonAmvisc Plus
All Cause Mortality
DisCoVisc®HealonAmvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN)
Serious Adverse Events
DisCoVisc®HealonAmvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/61 (0%) 0/60 (0%) 0/63 (0%)
Other (Not Including Serious) Adverse Events
DisCoVisc®HealonAmvisc Plus
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/61 (0%) 0/60 (0%) 0/63 (0%)

Limitations/Caveats

[Not Specified]

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/TitleDirector of Alcon Clinical
OrganizationAlcon Research, Ltd.
Phone888.451.3937; 817.568.6725
Emailmedinfo@alconlabs.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00763360
Other Study ID Numbers:
  • AUS-S-07-01
First Posted:
Sep 30, 2008
Last Update Posted:
Jan 24, 2012
Last Verified:
Dec 1, 2011