CataractNCT02782676
Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
A study testing Investigational Healon5 OVD and Healon5 OVD in people with Cataract, run by Abbott Medical Optics.
Trial summary
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Investigational Healon5 OVD and Healon5 OVD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- 21 Jun 2016to 4 May 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum 22 years of age
- Cataracts for which extraction and posterior IOL implantation have been planned for both eyes
- Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
- Clear intraocular media, other than cataract
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent and HIPAA authorization
Who cannot join
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Prior corneal refractive (LASIK- laser-assisted in situ keratomileusis, LASEK-laser-assisted sub-epithelial keratectomy, RK- radial keratectomy, PRK- photorefractive keratectomy, etc.) or intraocular surgery
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
- Conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
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- Use of systemic or ocular medications that may affect vision
- Prior, current, or anticipated use during the course of the 3-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
- Poorly-controlled diabetes
- Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.).
- Known steroid responder
- Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension (regardless of IOP value ), or glaucomatous changes in the optic nerve
- Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the lowest value of the three cell counts as taken by the Konan Specular Microscope)
- Known ocular disease or pathology that may affect visual acuity or that may be expected to require retinal laser treatment or other surgical intervention during the course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
- Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes
- Concurrent participation, or participation within 45 days prior to preoperative visit, in any other clinical trial
About this study
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
Read the detailed description
This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.
- Conditions
- Cataract
- Being tested
- Investigational Healon5 OVD, Healon5 OVD
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Healon5 OVDDevice
ophthalmic viscosurgical device
Healon5 OVDDevice
ophthalmic viscosurgical device
| Study group | Role | What they receive |
|---|---|---|
| Investigational Healon5 OVD | Experimental | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Receives: Device: Investigational Healon5 OVD |
| Approved Healon5 OVD | Active comparator | Subjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. Receives: Device: Healon5 OVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.
Measured: 3 months
Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.
Measured: 3 months
Secondary outcomes (10)
Ocular Serious Adverse Events (SAE)
Ocular serious and/or device related adverse event rates was be tabulated with the frequency and proportion of eyes with these events reported over time and cumulatively by OVD group.
- in the results table denotes SAEs determined to be device-related
Measured: 3 months
Mean Change in IOP From Baseline
The mean change in IOP from baseline for both OVD groups over time at the 6 hour, 1 day, 1 week, 1 month, and 3 month postoperative time points are presented.
Measured: 3 months
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
The rate of IOP spike 30 mmHg or greater at 6 hour, 1 day, 1 week, 1 month and 3 months postoperatively was tabulated with frequency and proportion by OVD group.
Measured: 3 months
Grade of Inflammation: Epithelial Edema
The grades of inflammation for epithelial edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 months
Grade of Inflammation: Stromal Edema
The grades of inflammation for stromal edema was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 months
Grade of Inflammation: Cells
The grades of inflammation for cells was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 months
Grade of Inflammation: Flare
The grades of inflammation for flare was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 months
Grade of Inflammation: Anterior Synechiae
The grades of inflammation for Anterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 months
Grade of Inflammation: Posterior Synechiae
The grades of inflammation for Posterior Synechiae was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 Months
Grade of Inflammation: Fibrin Presence
The grades of inflammation for Fibrin Presence was be tabulated with frequency and proportion of eyes with each grading for each event presented over time.
Measured: Upto 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study start21 Jun 2016
- Primary completion4 May 2017
- Study completion4 May 2017
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Optics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kendra Hileman, PhD, Study director, Abbott Medical Optics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782676
- Sponsor's protocol ID
- VSCO-109-HLN5
- Status last verified
- Jan 2025
- First submitted
- 23 May 2016
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Serious adverse event or other adverse event data and other data as needed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Bacterially-Derived Healon5 Ophthalmic Viscosurgical Device (OVD)
- ClinicalTrials.gov ID
- NCT02782676
- Acronym / sponsor ID
- VSCO-109-HLN5
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Abbott Medical OpticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 24 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicenter, paired-eye, randomized, masked, clinical trial of the bacterially-derived Healon5 OVD versus the currently available Healon5 OVD control.
Detailed description
This study will include only subjects undergoing bilateral, primary, cataract extraction and intraocular lens (IOL) implantation and who meet all of the study inclusion and exclusion criteria in both eyes. Subjects who meet the inclusion/exclusion criteria and agree to participate will be randomly assigned to receive the investigational OVD in one eye and the currently-available (i.e., commercial) OVD in the fellow eye (control). Thus, a single group of subjects will provide data for both the investigational OVD and the control OVD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Healon5 OVD | Experimental | Device: Investigational Healon5 OVDSubjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. |
| Approved Healon5 OVD | Active comparator | Device: Healon5 OVDSubjects to receive investigational Healon5 OVD in one eye and control Healon5 in the fellow eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum 22 years of age
- Cataracts for which extraction and posterior IOL implantation have been planned for both eyes
- Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or better
- Clear intraocular media, other than cataract
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
Key exclusion criteria (16 listed)
- Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)
- Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
- Prior corneal refractive (LASIK- laser-assisted in situ keratomileusis, LASEK-laser-assisted sub-epithelial keratectomy, RK- radial keratectomy, PRK- photorefractive keratectomy, etc.) or intraocular surgery
- Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study
- Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the study.
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 |
|---|---|---|
| Investigational Healon5 OVDophthalmic viscosurgical device | Device | Investigational Healon5 OVD |
| Healon5 OVDophthalmic viscosurgical device | Device | Approved Healon5 OVD |
Primary outcome
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively
Time frame: 3 months
The cumulative rate of IOP spikes with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 10%.
Mean Percent Endothelial Cell Count (ECC) Change Preoperatively vs. Postoperatively
Time frame: 3 months
The mean percent ECC change with the bacterially-derived Healon5 will be statistically non-inferior to that with the animal-derived Healon5 control using a non-inferiority margin of 5%.
10 secondary outcomes
Ocular Serious Adverse Events (SAE)
Time frame: 3 months
Mean Change in IOP From Baseline
Time frame: 3 months
Rate of IOP Spikes 30 mmHg or Greater at 3 Month Postoperatively
Time frame: 3 months
Grade of Inflammation: Epithelial Edema
Time frame: Upto 3 months
Grade of Inflammation: Stromal Edema
Time frame: Upto 3 months
Grade of Inflammation: Cells
Time frame: Upto 3 months
Grade of Inflammation: Flare
Time frame: Upto 3 months
Grade of Inflammation: Anterior Synechiae
Time frame: Upto 3 months
Grade of Inflammation: Posterior Synechiae
Time frame: Upto 3 Months
Grade of Inflammation: Fibrin Presence
Time frame: Upto 3 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Serious adverse event or other adverse event data and other data as needed.
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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.
Kendra Hileman, PhD study director
Abbott Medical Optics
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Healon5 OVD and Healon5 OVD in people with Cataract, run by Abbott Medical Optics.
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 6 inclusion and 16 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 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 24 May 2018). 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?
Cumulative Rates of Intraocular Pressure (IOP) Spikes 30mm of Mercury (mmHg) or Greater Measured Postoperatively (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Feb 2025.