DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

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

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Study Locations	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.

• 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 , ,: Discovisc; Ophthalmic Viscosurgical Device
• Additional relevant MeSH terms: Cataract; Hyaluronic Acid

Study Results

Participant Flow

Recruitment Details	Subjects 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 Detail	During 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Period Title: Overall Study
STARTED	29	29	27	27
COMPLETED	25	28	25	26
NOT COMPLETED	4	1	2	1

Baseline Characteristics

Arm/Group Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus	Total
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device	Total of all reporting groups
Overall Participants	29	29	27	27	112
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

Title	Corneal Endothelial Cell Loss
Description	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.
Time Frame	1 month after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	24	26	24	25
Mean (Standard Deviation) [Percent Change]	1.51 (5.99)	1.18 (11.18)	4.72 (7.23)	6.30 (14.31)

2. Secondary Outcome

Title	Percent Gain in Corneal Thickness.
Description	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.
Time Frame	1 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	25	28	25	26
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

Title	Aqueous Signs - Corneal Edema
Description	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.
Time Frame	1 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	26	26
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

Title	Aqueous Signs - Aqueous Flare
Description	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.
Time Frame	1 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	26	26
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

Title	Aqueous Signs - Aqueous Cells
Description	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.
Time Frame	1 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	26	26
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

Title	Intraocular Pressure (IOP)
Description	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.
Time Frame	1 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	26	25	25	26
Mean (Standard Deviation) [mmHg]	21.58 (8.42)	19.48 (4.6)	20.72 (6.61)	18.65 (5.56)

7. Secondary Outcome

Title	Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy
Description	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.
Time Frame	Time 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	27	27
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

Title	Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification
Description	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.
Time Frame	Time 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	27	27
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

Title	Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion
Description	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.
Time Frame	Time 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 Title	DISCOVISC	DUOVISC	Healon5	Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC® Viscoelastic system	Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Ophthalmic Viscosurgical Device
Measure Participants	29	28	27	27
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

Adverse Event Reporting Description	There were no adverse events reported for this study.
Arm/Group Title	DISCOVISC		DUOVISC		Healon5		Amvisc Plus
Arm/Group Description	DISCOVISC® Ophthalmic Viscosurgical Device (OVD)		DUOVISC® Viscoelastic system		Healon5 Ophthalmic Viscosurgical Device		Amvisc Plus Ophthalmic Viscosurgical Device
All Cause Mortality
	DISCOVISC		DUOVISC		Healon5		Amvisc Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	DISCOVISC		DUOVISC		Healon5		Amvisc Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/29 (0%)		0/27 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	DISCOVISC		DUOVISC		Healon5		Amvisc Plus
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (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.