DisCoVisc Comparative Evaluation

Cataracts Clinical Trial

Official title:

A Prospective, Non-randomized Comparison of DisCoVisc to Dispersive and Cohesive Ophthalmic Viscosurgical Devices (OVDs) in Non-eventful Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732225
• Other study ID #: M07-015
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2008
• Last updated: June 30, 2010
• Start date: May 2007

Study information

• Verified date: June 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 49 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

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.
• 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.
• BioVisc
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
• Healon5
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
• Amvisc Plus
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Loss of Endothelial Cells	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.	2 months following surgery	No
Secondary	Aqueous Signs - Corneal Edema	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	1 day after surgery	No
Secondary	Aqueous Signs - Aqueous Flare	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.	1 day following surgery	No
Secondary	Aqueous Signs - Aqueous Cells	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	1 day following surgery	No
Secondary	Intraocular Pressure (IOP)	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.	1 day following surgery	Yes
Secondary	Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy	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 of Surgery	No
Secondary	Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification	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 of Surgery	No
Secondary	Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion	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 of Surgery	No