Trial Outcomes & Findings for DisCoVisc Comparative Evaluation (NCT NCT00732225)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

173 participants

Primary outcome timeframe

2 months following surgery

Results posted on

2010-07-30

Participant Flow

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

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).

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	71	40	26	33	54
Overall Study COMPLETED	60	32	23	29	48
Overall Study NOT COMPLETED	11	8	3	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DisCoVisc Comparative Evaluation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DisCoVisc n=71 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=40 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=26 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=33 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=54 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)	Total n=224 Participants Total of all reporting groups
Age Continuous	66.8 years STANDARD_DEVIATION 9.54 • n=5 Participants	67.31 years STANDARD_DEVIATION 12.61 • n=7 Participants	71.48 years STANDARD_DEVIATION 8.56 • n=5 Participants	67.03 years STANDARD_DEVIATION 12.13 • n=4 Participants	66.24 years STANDARD_DEVIATION 10.51 • n=21 Participants	67.9 years STANDARD_DEVIATION 10.8 • n=8 Participants
Gender Female	42 participants n=5 Participants	22 participants n=7 Participants	13 participants n=5 Participants	19 participants n=4 Participants	29 participants n=21 Participants	125 participants n=8 Participants
Gender Male	27 participants n=5 Participants	16 participants n=7 Participants	12 participants n=5 Participants	14 participants n=4 Participants	23 participants n=21 Participants	92 participants n=8 Participants

PRIMARY outcome

Timeframe: 2 months following surgery

Population: This data was collected on the eyes of patients attending the visit 2 months after surgery.

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.

Outcome measures

Outcome measures
Measure	DisCoVisc n=64 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=32 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=23 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=29 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=46 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Percent Loss of Endothelial Cells	9.48 Percent Loss Standard Deviation 20.72	15.66 Percent Loss Standard Deviation 11.03	23.69 Percent Loss Standard Deviation 13.47	25.70 Percent Loss Standard Deviation 13.94	23.04 Percent Loss Standard Deviation 16.20

SECONDARY outcome

Timeframe: 1 day after surgery

Population: This data was collected on all eyes of patients attending the 1-day visit.

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=75 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=41 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=24 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=33 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=55 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Aqueous Signs - Corneal Edema None	81.33 Percentage of Eyes	78.05 Percentage of Eyes	37.50 Percentage of Eyes	63.64 Percentage of Eyes	54.55 Percentage of Eyes
Aqueous Signs - Corneal Edema Severe	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes
Aqueous Signs - Corneal Edema Mild	14.67 Percentage of Eyes	19.51 Percentage of Eyes	37.50 Percentage of Eyes	30.30 Percentage of Eyes	32.73 Percentage of Eyes
Aqueous Signs - Corneal Edema Moderate	4.00 Percentage of Eyes	2.44 Percentage of Eyes	25.00 Percentage of Eyes	6.06 Percentage of Eyes	12.73 Percentage of Eyes

SECONDARY outcome

Timeframe: 1 day following surgery

Population: This data was collected on all eyes of patients attending the 1 day postoperative visit.

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. 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 the 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=75 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=41 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=24 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=33 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=55 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Aqueous Signs - Aqueous Flare Moderate	2.67 Percentage of Eyes	4.88 Percentage of Eyes	25.00 Percentage of Eyes	12.12 Percentage of Eyes	10.91 Percentage of Eyes
Aqueous Signs - Aqueous Flare None	76.00 Percentage of Eyes	75.61 Percentage of Eyes	41.67 Percentage of Eyes	63.64 Percentage of Eyes	54.55 Percentage of Eyes
Aqueous Signs - Aqueous Flare Mild	21.33 Percentage of Eyes	19.51 Percentage of Eyes	33.33 Percentage of Eyes	24.24 Percentage of Eyes	34.55 Percentage of Eyes
Aqueous Signs - Aqueous Flare Severe	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes

SECONDARY outcome

Timeframe: 1 day following surgery

Population: This data was collected on all eyes of patients attending the 1 day post-operative visit.

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 to 30 cells 4. \- \>30 cells

Outcome measures

Outcome measures
Measure	DisCoVisc n=75 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=41 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=24 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=33 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=55 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Aqueous Signs - Aqueous Cells Grade 0	84.00 Percentage of Eyes	80.49 Percentage of Eyes	45.83 Percentage of Eyes	63.64 Percentage of Eyes	56.36 Percentage of Eyes
Aqueous Signs - Aqueous Cells Grade 1	16.00 Percentage of Eyes	17.07 Percentage of Eyes	25.00 Percentage of Eyes	27.27 Percentage of Eyes	36.36 Percentage of Eyes
Aqueous Signs - Aqueous Cells Grade 2	0.00 Percentage of Eyes	2.44 Percentage of Eyes	29.17 Percentage of Eyes	9.09 Percentage of Eyes	7.27 Percentage of Eyes
Aqueous Signs - Aqueous Cells Grade 3	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes
Aqueous Signs - Aqueous Cells Grade 4	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes

SECONDARY outcome

Timeframe: 1 day following surgery

Population: This data was collected on all eyes of patients attending the 1 day postoperative visit with the exception of the following: 3 DisCoVisc patients, 4 DuoVisc patients, 1 Healon5 patient, and 4 Amvisc Plus patients.

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.

Outcome measures

Outcome measures
Measure	DisCoVisc n=72 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=37 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=25 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=32 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=51 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Intraocular Pressure (IOP)	17.67 mmHg Standard Deviation 3.88	17.78 mmHg Standard Deviation 3.81	20.32 mmHg Standard Deviation 7.39	19.88 mmHg Standard Deviation 8.90	16.96 mmHg Standard Deviation 4.76

SECONDARY outcome

Timeframe: Time of Surgery

Population: This data was collected on all eyes of patients undergoing surgery with the exception of the following: 2 DisCoVisc eyes and 2 Healon5 eyes

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.

Outcome measures

Outcome measures
Measure	DisCoVisc n=74 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=41 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=25 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=33 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=55 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Shallow	2.70 Percentage of Eyes	0.00 Percentage of Eyes	100.00 Percentage of Eyes	9.09 Percentage of Eyes	85.45 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Working Space Adequate	13.51 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	3.64 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Full Chamber Maintenance	83.78 Percentage of Eyes	100.00 Percentage of Eyes	0.00 Percentage of Eyes	90.91 Percentage of Eyes	10.91 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy Flat	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes

SECONDARY outcome

Timeframe: Time of Surgery

Population: This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 19 DuoVisc eyes, 6 BioVisc eyes,3 Healon5 eyes, and 11 Amvisc Plus eyes.

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

Outcome measures

Outcome measures
Measure	DisCoVisc n=59 Participants Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate)	DuoVisc n=22 Participants Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate)	BioVisc n=20 Participants Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate)	Healon5 n=30 Participants AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate)	AmviscPlus n=42 Participants Bausch \& Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate)
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification Shallow	0.00 Percentage of Eyes	0.00 Percentage of Eyes	25.00 Percentage of Eyes	0.00 Percentage of Eyes	2.38 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification Working Space Adequate	10.17 Percentage of Eyes	9.09 Percentage of Eyes	70.00 Percentage of Eyes	36.67 Percentage of Eyes	80.95 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification Flat	0.00 Percentage of Eyes	0.0 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes	0.00 Percentage of Eyes
Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification Full Chamber Maintenance	89.83 Percentage of Eyes	90.91 Percentage of Eyes	5.00 Percentage of Eyes	63.33 Percentage of Eyes	16.67 Percentage of Eyes

SECONDARY outcome

Timeframe: Time of Surgery

Population: This data was collected on all eyes of patients undergoing surgery with the exception of the following: 17 DisCoVisc eyes, 20 DuoVisc eyes, 6 BioVisc eyes,4 Healon5 eyes, and 14 Amvisc Plus eyes.

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