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DisCoVisc Comparative Evaluation

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00732225
First received: August 7, 2008
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
Results First Received: March 31, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cataracts
Interventions: Device: DisCoVisc
Device: DuoVisc
Device: BioVisc
Device: Healon5
Device: Amvisc Plus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
DisCoVisc Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5 AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
AmviscPlus Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)

Participant Flow:   Overall Study
    DisCoVisc     DuoVisc     BioVisc     Healon5     AmviscPlus  
STARTED     71 [1]   40 [2]   26 [3]   33 [4]   54 [5]
COMPLETED     60 [6]   32 [7]   23 [8]   29 [9]   48 [10]
NOT COMPLETED     11     8     3     4     6  
[1] 76 eyes of 71 patients
[2] 41 eyes of 40 patients
[3] 26 eyes of 26 patients
[4] 33 eyes of 33 patients
[5] 55 eyes of 54 patients
[6] 64 eyes of 60 patients
[7] 33 eyes of 32 patients
[8] 23 eyes of 23 patients
[9] 29 eyes of 29 patients
[10] 48 eyes of 48 patients



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
DisCoVisc Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)
DuoVisc Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)
BioVisc Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)
Healon5 AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)
AmviscPlus Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Total Total of all reporting groups

Baseline Measures
    DisCoVisc     DuoVisc     BioVisc     Healon5     AmviscPlus     Total  
Number of Participants  
[units: participants]
 		  71     40     26     33     54     224  
Age [1]
[units: years]
Mean (Standard Deviation) 		  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 [2]
[units: participants]
 		           
Female     42     22     13     19     29     125  
Male     27     16     12     14     23     92  
[1] Age not available for the following: 7 Discovisc patients, 11 Duovisc patients, 3 Biovisc patients, 4 Amvisc Plus patients. Total mean age and standard deviation not calculated.
[2] Gender not available for the following: 2 Discovisc patients, 2 Duovisc patients, 1 Biovisc patient, 2 Amvisc Plus patients.



  Outcome Measures
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1.  Primary:   Percent Loss of Endothelial Cells   [ Time Frame: 2 months following surgery ]
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2.  Secondary:   Aqueous Signs - Corneal Edema   [ Time Frame: 1 day after surgery ]
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3.  Secondary:   Aqueous Signs – Aqueous Flare   [ Time Frame: 1 day following surgery ]
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4.  Secondary:   Aqueous Signs - Aqueous Cells   [ Time Frame: 1 day following surgery ]
  Show Outcome Measure 4

5.  Secondary:   Intraocular Pressure (IOP)   [ Time Frame: 1 day following surgery ]
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6.  Secondary:   Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy   [ Time Frame: Time of Surgery ]
  Show Outcome Measure 6

7.  Secondary:   Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification   [ Time Frame: Time of Surgery ]
  Show Outcome Measure 7

8.  Secondary:   Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion   [ Time Frame: Time of Surgery ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
At the time of surgery, patients were assigned to a study group based on the availability of study Ophthalmic Viscosurgical Devices (OVDs).


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Alcon Clinical
Organization: Alcon Research, Ltd.
phone: 888.451.3937; 817.568.6725
e-mail: medinfo@alconlabs.com



Responsible Party: Rick Potvin/Director - Global Scientific Market Affairs, Alcon Research
ClinicalTrials.gov Identifier: NCT00732225     History of Changes
Other Study ID Numbers: M07-015
Study First Received: August 7, 2008
Results First Received: March 31, 2010
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board