Cataract
Conditions
Keywords
Cataract, Intraocular Lens, IOL, Aphakia
Brief summary
The purpose of this multicenter, prospective, randomized clinical study is to determine the safety and effectiveness of the EYEFILL® C.-US Viscoelastic in patients undergoing cataract extraction and intraocular lens (IOL) implantation surgery. EYEFILL® C.-US Viscoelastic is designed to create and maintain space, to protect the corneal endothelium and other intraocular tissues, and to manipulate tissues during surgery. EYEFILL® C.-US Viscoelastic may also be used to coat intraocular lenses and instruments during cataract extraction and intraocular lens insertion.
Interventions
DEVICEEYEFILL® C.-US Viscoelastic
EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
DEVICEHealon® Viscoelastic (CONTROL)
Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
Sponsors
Bausch & Lomb Incorporated
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any race * Older than 21 years * Cataract requiring cataract extraction in at least 1 eye * Clear intraocular media other than cataract * Able to provide written informed consent * Able and willing to comply with required follow-up schedule * Competent to understand the procedure and the actions asked of him/her as a research subject
Exclusion criteria
* Monocular * Ocular infection * History of glaucoma, Ocular Hypertension (IOP \> 21 mmHg) likely to require IOP lowering medications, ocular condition requiring IOP lowering medication, condition preventing reliable Goldmann applanation tonometry, known steroid responder * Previous intraocular surgery in the operative eye * Previous serious corneal disease or known endothelial cell loss / damage (in operative eye) * History of chronic or recurrent inflammatory eye disease (in operative eye) * Evidence of retinal vascular disease (in operative eye) * Uncontrolled diabetes or proliferative diabetic retinopathy * Acute or chronic disease or illness that would increase the operative risk * Allergy to anesthetics or other postoperative medications * Known hypersensitivity to sodium hyaluronate or other components in viscoelastic * Patient in any other clinical trial within the 30 days prior to the start of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Cell Change (Preservation of Endothelium) | Baseline, 3 months | Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit | 3 months |
| Percentage of Participants With Anterior Chamber Inflammation | 3 months |
| Percentage of Participants With Device-related Adverse Events Any Visit | 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EYEFILL® C.-US Viscoelastic EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
EYEFILL® C.-US Viscoelastic: EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. | 130 |
| Healon® Viscoelastic (CONTROL) Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
Healon® Viscoelastic (CONTROL): Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries. | 132 |
| Total | 262 |
Baseline characteristics
| Characteristic | EYEFILL® C.-US Viscoelastic | Healon® Viscoelastic (CONTROL) | Total |
|---|---|---|---|
| Age, Continuous | 69.4 years | 68.7 years | 69.0 years |
| Sex: Female, Male Female | 75 Participants | 78 Participants | 153 Participants |
| Sex: Female, Male Male | 55 Participants | 54 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 130 | 72 / 132 |
| serious Total, serious adverse events | 1 / 130 | 2 / 132 |
Outcome results
Primary
Mean Percent Cell Change (Preservation of Endothelium)
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Time frame: Baseline, 3 months
Population: Participants with endothelial cell density recorded at baseline and 3 months are included in the population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EYEFILL® C.-US Viscoelastic | Mean Percent Cell Change (Preservation of Endothelium) | -10.05 percent cell change | Standard Deviation 15.06 |
| Healon® Viscoelastic (CONTROL) | Mean Percent Cell Change (Preservation of Endothelium) | -10.13 percent cell change | Standard Deviation 15.92 |
Secondary
Percentage of Participants With Anterior Chamber Inflammation
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Anterior Chamber Inflammation | Day 1 | 2 Participants |
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Anterior Chamber Inflammation | Day 7 | 2 Participants |
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Anterior Chamber Inflammation | Day 30 | 4 Participants |
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Anterior Chamber Inflammation | Day 90 | 0 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Anterior Chamber Inflammation | Day 90 | 0 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Anterior Chamber Inflammation | Day 1 | 4 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Anterior Chamber Inflammation | Day 30 | 3 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Anterior Chamber Inflammation | Day 7 | 3 Participants |
Secondary
Percentage of Participants With Device-related Adverse Events Any Visit
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Device-related Adverse Events Any Visit | 0 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Device-related Adverse Events Any Visit | 0 Participants |
Secondary
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EYEFILL® C.-US Viscoelastic | Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit | 24 Participants |
| Healon® Viscoelastic (CONTROL) | Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit | 20 Participants |