Trial Outcomes & Findings for DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus (NCT NCT00712244)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

112 participants

Primary outcome timeframe

1 month after surgery

Results posted on

2010-09-14

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	DISCOVISC DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC DUOVISC® Viscoelastic system	Healon5 Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus Amvisc Plus Ophthalmic Viscosurgical Device
Overall Study STARTED	29	29	27	27
Overall Study COMPLETED	25	28	25	26
Overall Study NOT COMPLETED	4	1	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DisCoVisc Versus DuoVisc, Healon5 and AmVisc Plus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=29 Participants DUOVISC® Viscoelastic system	Healon5 n=27 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=27 Participants Amvisc Plus Ophthalmic Viscosurgical Device	Total n=112 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age Categorical Between 18 and 65 years	12 participants n=5 Participants	12 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	41 participants n=21 Participants
Age Categorical >=65 years	16 participants n=5 Participants	15 participants n=7 Participants	18 participants n=5 Participants	18 participants n=4 Participants	67 participants n=21 Participants
Gender Female	18 participants n=5 Participants	15 participants n=7 Participants	16 participants n=5 Participants	19 participants n=4 Participants	68 participants n=21 Participants
Gender Male	10 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	7 participants n=4 Participants	40 participants n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=24 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=26 Participants DUOVISC® Viscoelastic system	Healon5 n=24 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=25 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Corneal Endothelial Cell Loss	1.51 Percent Change Standard Deviation 5.99	1.18 Percent Change Standard Deviation 11.18	4.72 Percent Change Standard Deviation 7.23	6.30 Percent Change Standard Deviation 14.31

SECONDARY outcome

Timeframe: 1 week and month after surgery

Population: Participants analyzed for Baseline to 1 week: 29 DisCovisc, 28 DuoVisc, 26 Healon5, 26 Amvisc Plus.

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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=25 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=25 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=26 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Percent Gain in Corneal Thickness. Before Surgery to 1 Week after Surgery	2.89 Percent Gain Standard Deviation 16.45	7.02 Percent Gain Standard Deviation 12.06	9.92 Percent Gain Standard Deviation 15.29	5.06 Percent Gain Standard Deviation 12.07
Percent Gain in Corneal Thickness. Before Surgery to 1 Month after Surgery	-0.55 Percent Gain Standard Deviation 11.79	-1.06 Percent Gain Standard Deviation 25.38	1.98 Percent Gain Standard Deviation 10.57	-9.11 Percent Gain Standard Deviation 22.85

SECONDARY outcome

Timeframe: 1 day after surgery

Population: This data was collected for all subjects attending the visit one 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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=26 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=26 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Aqueous Signs - Corneal Edema Moderate	3.45 Percentage of Participants	3.57 Percentage of Participants	7.69 Percentage of Participants	0 Percentage of Participants
Aqueous Signs - Corneal Edema Severe	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants	0 Percentage of Participants
Aqueous Signs - Corneal Edema None	68.97 Percentage of Participants	75 Percentage of Participants	57.69 Percentage of Participants	65.38 Percentage of Participants
Aqueous Signs - Corneal Edema Mild	57.59 Percentage of Participants	21.43 Percentage of Participants	34.62 Percentage of Participants	34.62 Percentage of Participants

SECONDARY outcome

Timeframe: 1 Day after Surgery

Population: This data was collected for all subjects attending the visit one 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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=26 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=26 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Aqueous Signs - Aqueous Flare Mild	75.86 Percentage of participants	53.57 Percentage of participants	65.38 Percentage of participants	53.85 Percentage of participants
Aqueous Signs - Aqueous Flare None	20.69 Percentage of participants	39.29 Percentage of participants	26.92 Percentage of participants	46.15 Percentage of participants
Aqueous Signs - Aqueous Flare Moderate	3.45 Percentage of participants	7.14 Percentage of participants	7.69 Percentage of participants	0 Percentage of participants
Aqueous Signs - Aqueous Flare Severe	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 1 day after surgery

Population: This data was collected for all subjects attending the visit one 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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=26 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=26 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Aqueous Signs - Aqueous Cells Grade 0	6.9 Percentage of participants	14.29 Percentage of participants	7.69 Percentage of participants	7.69 Percentage of participants
Aqueous Signs - Aqueous Cells Grade 1	65.52 Percentage of participants	46.43 Percentage of participants	50 Percentage of participants	65.38 Percentage of participants
Aqueous Signs - Aqueous Cells Grade 2	24.14 Percentage of participants	32.14 Percentage of participants	38.46 Percentage of participants	23.08 Percentage of participants
Aqueous Signs - Aqueous Cells Grade 3	3.45 Percentage of participants	7.14 Percentage of participants	3.85 Percentage of participants	3.85 Percentage of participants
Aqueous Signs - Aqueous Cells Grade 4	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: 1 day after surgery

Population: 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.

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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=26 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=25 Participants DUOVISC® Viscoelastic system	Healon5 n=25 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=26 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Intraocular Pressure (IOP)	21.58 mmHg Standard Deviation 8.42	19.48 mmHg Standard Deviation 4.6	20.72 mmHg Standard Deviation 6.61	18.65 mmHg Standard Deviation 5.56

SECONDARY outcome

Timeframe: Time of surgery

Population: This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.

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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=27 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=27 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Working Space Adequate	0 Percentage of participants	7.14 Percentage of participants	48.15 Percentage of participants	55.56 Percentage of participants
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Flat	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Shallow	3.45 Percentage of participants	3.57 Percentage of participants	22.22 Percentage of participants	18.52 Percentage of participants
Surgeon Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Full Chamber Maintenance	96.55 Percentage of participants	89.29 Percentage of participants	29.63 Percentage of participants	25.93 Percentage of participants

SECONDARY outcome

Timeframe: Time of Surgery

Population: This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.

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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=27 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=27 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification Flat	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification Shallow	0 Percentage of participants	0 Percentage of participants	11.11 Percentage of participants	3.7 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification Working Space Adequate	0 Percentage of participants	3.57 Percentage of participants	51.85 Percentage of participants	48.15 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Phacoemulsification Full Chamber Maintenance	100 Percentage of participants	96.43 Percentage of participants	37.04 Percentage of participants	48.15 Percentage of participants

SECONDARY outcome

Timeframe: Time of Surgery

Population: This data was collected on all subjects undergoing surgery with the exception of 1 DuoVisc subject.

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.

Outcome measures

Outcome measures
Measure	DISCOVISC n=29 Participants DISCOVISC® Ophthalmic Viscosurgical Device (OVD)	DUOVISC n=28 Participants DUOVISC® Viscoelastic system	Healon5 n=27 Participants Healon5 Ophthalmic Viscosurgical Device	Amvisc Plus n=27 Participants Amvisc Plus Ophthalmic Viscosurgical Device
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion Flat	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion Shallow	0 Percentage of participants	0 Percentage of participants	40.74 Percentage of participants	7.41 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion Working Space Adequate	0 Percentage of participants	7.14 Percentage of participants	25.93 Percentage of participants	44.44 Percentage of participants
Surgeon Surgey - Anterior Dome Maintenance During Intraocular Lens (IOL) Insertion Full Chamber Maintenance	100 Percentage of participants	92.86 Percentage of participants	33.33 Percentage of participants	48.15 Percentage of participants

Adverse Events

DISCOVISC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DUOVISC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healon5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Amvisc Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.
Publication restrictions are in place

Restriction type: OTHER