Cataracts
Conditions
Keywords
DisCoVisc OVD, Ophthalmic Viscosurgical Device
Brief 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.
Interventions
DEVICEDisCoVisc
DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
DEVICEDuoVisc
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.
DEVICEBioVisc
BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
DEVICEHealon5
Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
DEVICEAmvisc Plus
Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) as utilized throughout cataract removal and intraocular lens (IOL) insertion procedure.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
49 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Loss of Endothelial Cells | 2 months following 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aqueous Signs - Aqueous Flare | 1 day following 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 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. |
| Aqueous Signs - Aqueous Cells | 1 day following 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 to 30 cells 4. \- \>30 cells |
| Intraocular Pressure (IOP) | 1 day following surgery | 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. |
| 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 |
| Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Time of Surgery | 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 |
| Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Time of Surgery | 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 |
| Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Time of Surgery | 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. |
Countries
United States
Participant flow
Recruitment details
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
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).
Participants by arm
| Arm | Count |
|---|---|
| DisCoVisc Alcon DisCoVisc Ophthalmic Viscosurgical Device (OVD) (4% sodium chondroitin sulfate, 1.65% sodium hyaluronate) | 71 |
| DuoVisc Alcon DuoVisc Ophthalmic Viscosurgical System (1% sodium hyaluronate, and 3% sodium hyaluronate, 4% chondroitin sulfate) | 40 |
| BioVisc Sophia Lab BioVisc Ophthalmic Viscosurgical Device (OVD) (1% sodium hyaluronate) | 26 |
| Healon5 AMO Healon5 Ophthalmic Viscosurgical Device (OVD) (2.3% Sodium Hyaluronate) | 33 |
| AmviscPlus Bausch & Lomb AmviscPlus Ophthalmic Viscosurgical Device (OVD) (1.6% Sodium Hyaluronate) | 54 |
| Total | 224 |
Baseline characteristics
| Characteristic | Total | DisCoVisc | DuoVisc | BioVisc | Healon5 | AmviscPlus |
|---|---|---|---|---|---|---|
| Age Continuous | 67.9 years STANDARD_DEVIATION 10.8 | 66.8 years STANDARD_DEVIATION 9.54 | 67.31 years STANDARD_DEVIATION 12.61 | 71.48 years STANDARD_DEVIATION 8.56 | 67.03 years STANDARD_DEVIATION 12.13 | 66.24 years STANDARD_DEVIATION 10.51 |
| Gender Female | 125 participants | 42 participants | 22 participants | 13 participants | 19 participants | 29 participants |
| Gender Male | 92 participants | 27 participants | 16 participants | 12 participants | 14 participants | 23 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 41 | 0 / 26 | 0 / 33 | 0 / 55 |
| serious Total, serious adverse events | 0 / 76 | 0 / 41 | 0 / 26 | 0 / 33 | 0 / 55 |
Outcome results
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.
Time frame: 2 months following surgery
Population: This data was collected on the eyes of patients attending the visit 2 months after surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DisCoVisc | Percent Loss of Endothelial Cells | 9.48 Percent Loss | Standard Deviation 20.72 |
| DuoVisc | Percent Loss of Endothelial Cells | 15.66 Percent Loss | Standard Deviation 11.03 |
| BioVisc | Percent Loss of Endothelial Cells | 23.69 Percent Loss | Standard Deviation 13.47 |
| Healon5 | Percent Loss of Endothelial Cells | 25.70 Percent Loss | Standard Deviation 13.94 |
| AmviscPlus | Percent Loss of Endothelial Cells | 23.04 Percent Loss | Standard Deviation 16.2 |
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. \- 1 to 5 cells 2. \- 6 to 15 cells 3. \- 16 to 30 cells 4. \- \>30 cells
Time frame: 1 day following surgery
Population: This data was collected on all eyes of patients attending the 1 day post-operative visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Aqueous Signs - Aqueous Cells | Grade 3 | 0.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Cells | Grade 0 | 84.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Cells | Grade 4 | 0.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Cells | Grade 1 | 16.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Cells | Grade 2 | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Cells | Grade 3 | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Cells | Grade 2 | 2.44 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Cells | Grade 1 | 17.07 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Cells | Grade 4 | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Cells | Grade 0 | 80.49 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Cells | Grade 2 | 29.17 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Cells | Grade 0 | 45.83 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Cells | Grade 1 | 25.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Cells | Grade 3 | 0.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Cells | Grade 4 | 0.00 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Cells | Grade 4 | 0.00 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Cells | Grade 0 | 63.64 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Cells | Grade 3 | 0.00 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Cells | Grade 2 | 9.09 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Cells | Grade 1 | 27.27 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Cells | Grade 2 | 7.27 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Cells | Grade 3 | 0.00 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Cells | Grade 0 | 56.36 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Cells | Grade 4 | 0.00 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Cells | Grade 1 | 36.36 Percentage of Eyes |
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. 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.
Time frame: 1 day following surgery
Population: This data was collected on all eyes of patients attending the 1 day postoperative visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Aqueous Signs - Aqueous Flare | None | 76.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Flare | Mild | 21.33 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Flare | Moderate | 2.67 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Aqueous Flare | Severe | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Flare | None | 75.61 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Flare | Severe | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Flare | Mild | 19.51 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Aqueous Flare | Moderate | 4.88 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Flare | Severe | 0.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Flare | Mild | 33.33 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Flare | Moderate | 25.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Aqueous Flare | None | 41.67 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Flare | None | 63.64 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Flare | Mild | 24.24 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Flare | Severe | 0.00 Percentage of Eyes |
| Healon5 | Aqueous Signs - Aqueous Flare | Moderate | 12.12 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Flare | Severe | 0.00 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Flare | Moderate | 10.91 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Flare | Mild | 34.55 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Aqueous Flare | None | 54.55 Percentage of Eyes |
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 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
Population: This data was collected on all eyes of patients attending the 1-day visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Aqueous Signs - Corneal Edema | None | 81.33 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Corneal Edema | Mild | 14.67 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Corneal Edema | Moderate | 4.00 Percentage of Eyes |
| DisCoVisc | Aqueous Signs - Corneal Edema | Severe | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Corneal Edema | None | 78.05 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Corneal Edema | Severe | 0.00 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Corneal Edema | Mild | 19.51 Percentage of Eyes |
| DuoVisc | Aqueous Signs - Corneal Edema | Moderate | 2.44 Percentage of Eyes |
| BioVisc | Aqueous Signs - Corneal Edema | Severe | 0.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Corneal Edema | Mild | 37.50 Percentage of Eyes |
| BioVisc | Aqueous Signs - Corneal Edema | Moderate | 25.00 Percentage of Eyes |
| BioVisc | Aqueous Signs - Corneal Edema | None | 37.50 Percentage of Eyes |
| Healon5 | Aqueous Signs - Corneal Edema | None | 63.64 Percentage of Eyes |
| Healon5 | Aqueous Signs - Corneal Edema | Mild | 30.30 Percentage of Eyes |
| Healon5 | Aqueous Signs - Corneal Edema | Severe | 0.00 Percentage of Eyes |
| Healon5 | Aqueous Signs - Corneal Edema | Moderate | 6.06 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Corneal Edema | Severe | 0.00 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Corneal Edema | Moderate | 12.73 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Corneal Edema | Mild | 32.73 Percentage of Eyes |
| AmviscPlus | Aqueous Signs - Corneal Edema | None | 54.55 Percentage of Eyes |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DisCoVisc | Intraocular Pressure (IOP) | 17.67 mmHg | Standard Deviation 3.88 |
| DuoVisc | Intraocular Pressure (IOP) | 17.78 mmHg | Standard Deviation 3.81 |
| BioVisc | Intraocular Pressure (IOP) | 20.32 mmHg | Standard Deviation 7.39 |
| Healon5 | Intraocular Pressure (IOP) | 19.88 mmHg | Standard Deviation 8.9 |
| AmviscPlus | Intraocular Pressure (IOP) | 16.96 mmHg | Standard Deviation 4.76 |
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 frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Working Space Adequate | 13.51 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Shallow | 2.70 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Full Chamber Maintenance | 83.78 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Flat | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Working Space Adequate | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Flat | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Full Chamber Maintenance | 100.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Shallow | 0.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Working Space Adequate | 0.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Shallow | 100.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Flat | 0.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Full Chamber Maintenance | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Shallow | 9.09 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Flat | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Working Space Adequate | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Full Chamber Maintenance | 90.91 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Flat | 0.00 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Shallow | 85.45 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Full Chamber Maintenance | 10.91 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Anterior Capsulotomy | Working Space Adequate | 3.64 Percentage of Eyes |
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 frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Flat | 0.00 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Shallow | 0.00 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Working Chamber Adequate | 3.39 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Full Chamber Maintenance | 96.61 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Flat | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Full Chamber Maintenance | 90.48 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Shallow | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Working Chamber Adequate | 9.52 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Full Chamber Maintenance | 0.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Shallow | 10.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Working Chamber Adequate | 90.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Flat | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Flat | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Shallow | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Full Chamber Maintenance | 75.86 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Working Chamber Adequate | 24.14 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Full Chamber Maintenance | 26.83 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Working Chamber Adequate | 68.29 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Shallow | 4.88 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During IOL Insertion | Flat | 0.00 Percentage of Eyes |
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 frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Shallow | 0.00 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Flat | 0.00 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Full Chamber Maintenance | 89.83 Percentage of Eyes |
| DisCoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Working Space Adequate | 10.17 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Flat | 0.0 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Shallow | 0.00 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Working Space Adequate | 9.09 Percentage of Eyes |
| DuoVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Full Chamber Maintenance | 90.91 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Working Space Adequate | 70.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Shallow | 25.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Full Chamber Maintenance | 5.00 Percentage of Eyes |
| BioVisc | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Flat | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Shallow | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Flat | 0.00 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Full Chamber Maintenance | 63.33 Percentage of Eyes |
| Healon5 | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Working Space Adequate | 36.67 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Full Chamber Maintenance | 16.67 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Flat | 0.00 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Working Space Adequate | 80.95 Percentage of Eyes |
| AmviscPlus | Physician Survey - Anterior Chamber Dome Maintenance During Phacoemulsification | Shallow | 2.38 Percentage of Eyes |