CataractNCT02024711
EYEFILL® C. -US Viscoelastic Clinical Investigation
A study testing EYEFILL® C.-US Viscoelastic in people with Cataract, run by Bausch Health Americas, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- EYEFILL® C.-US Viscoelastic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2013to 17 Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Argus Research at Cape Coral Eye Center
Cape Coral, Florida, 33904
Eye Centers of Florida
Fort Myers, Florida, 33901
Silverstein Eye Centers
Kansas City, Missouri, 64133
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, 85016
Shasta Eye Medical Group
Redding, California, 96002
Great Lakes Eye Care
Saint Joseph, Michigan, 49085
Newsom Eye and Laser Center
Sebring, Florida, 33870
Comprehensive Eye Care
Washington, Missouri, 63090
About this study
Official title: EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
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.
- Conditions
- Cataract
- Being tested
- EYEFILL® C.-US Viscoelastic, Healon® Viscoelastic (CONTROL)
- Keywords
- Cataract, Intraocular Lens, IOL, Aphakia
- Medical subject headings
- Cataract, Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYEFILL® C.-US ViscoelasticDevice
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.
Healon® Viscoelastic (CONTROL)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| EYEFILL® C.-US Viscoelastic | Experimental | 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. Receives: Device: EYEFILL® C.-US Viscoelastic |
| Healon® Viscoelastic (CONTROL) | Active comparator | 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. Receives: Device: Healon® Viscoelastic (CONTROL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Cell Change (Preservation of Endothelium)
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
Measured: Baseline, 3 months
Secondary outcomes (3)
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Measured: 3 months
Percentage of Participants With Anterior Chamber Inflammation
Measured: 3 months
Percentage of Participants With Device-related Adverse Events Any Visit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion17 Dec 2014
- Study completion17 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Donald R Sanders, MD, PhD, Study director, Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024711
- Sponsor's protocol ID
- EYE-C-7.00
- Status last verified
- Sep 2020
- First submitted
- 27 Dec 2013
- Last updated
- 4 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EYEFILL® C.-US Viscoelastic Clinical Investigational Protocol- For Institutional Review Boards / Ethical Review Committees and Clinical Investigators
- ClinicalTrials.gov ID
- NCT02024711
- Acronym / sponsor ID
- EYE-C-7.00
- Conditions
- Cataract
- Keywords
- Cataract, Intraocular Lens, IOL, Aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Dec 2013
- Primary completion
- 17 Dec 2014 (actual)
- Study completion
- 17 Dec 2014 (actual)
- First posted
- 31 Dec 2013 (estimated)
- Results
- Posted 4 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EYEFILL® C.-US Viscoelastic | Experimental | Device: EYEFILL® C.-US ViscoelasticEYEFILL ® 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. |
| Healon® Viscoelastic (CONTROL) | Active comparator | Device: 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EYEFILL® C.-US ViscoelasticEYEFILL ® 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. | Device | EYEFILL® C.-US Viscoelastic |
| 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. | Device | Healon® Viscoelastic (CONTROL) |
Primary outcome
Mean Percent Cell Change (Preservation of Endothelium)
Time frame: Baseline, 3 months
Preservation of endothelium was assessed by specular microscope photographs to determine endothelial cell density.
3 secondary outcomes
Percentage of Participants With Intraocular Pressure (IOP) Spikes >/= 30 mmHg Any Postoperative Visit
Time frame: 3 months
Percentage of Participants With Anterior Chamber Inflammation
Time frame: 3 months
Percentage of Participants With Device-related Adverse Events Any Visit
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald R Sanders, MD, PhD study director
Center for Clinical Research
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EYEFILL® C.-US Viscoelastic in people with Cataract, run by Bausch Health Americas, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Cell Change (Preservation of Endothelium) (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.