Clinical Evaluation of a New Viscoelastic for Cataract Surgery

A study testing Vitrax II and Viscoat in people with Cataract, run by Abbott Medical Optics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the safety and effectiveness of a new opthalmic viscoelastic material for the use in cataract surgery. The new viscoelastic will be compared to a currently marketed viscoelastic material. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract
What is being tested?: Vitrax II and Viscoat
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2009to 30 Nov 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Otherwise healthy eye with no pathology other than the presence of cataract
Visual potential of 20/40 or better

Who cannot join

Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
Known intraocular pressure increases from steroid treatment
Low endothelial cell count

Trial locations and contacts

1 site in 1 country.

United States1 site

AMO Clinical Research Call Center for Trial Locations
Santa Ana, California, 92799

Other trials in United States

About this study

Conditions: Cataract
Being tested: Vitrax II, Viscoat
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitrax IIDevice
Viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.
ViscoatDevice
Currently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..

Study groups in NCT00972621
Study group	Role	What they receive
Vitrax II	Experimental	Investigational dispersive viscoelastic Receives: Device: Vitrax II
Viscoat	Active comparator	Marketed control dispersive viscoelastic Receives: Device: Viscoat

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.
Measured: 3 months postoperative

Secondary outcomes (1)

Postoperative Mean Endothelial Cell Count
mean endothelial cell count (measured by Konan specular microscope) at 3 months
Measured: 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 200930 Nov 2010

First posted7 Sep 2009 (estimated)
Study start30 Sep 2009
Primary completion30 Nov 2010
Study completion30 Nov 2010

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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 400 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00972621
Sponsor's protocol ID: VSCO-106-DISP
Status last verified: Feb 2025
First submitted: 3 Sep 2009
Last updated: 11 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
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Effects of Oxygen Cage Support During Cataract Surgery
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Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
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Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a New Viscoelastic for Cataract Surgery
ClinicalTrials.gov ID: NCT00972621
Acronym / sponsor ID: VSCO-106-DISP
Conditions: Cataract
Study type: Interventional
Recruitment status: Completed
Enrolment: 400 participants (actual)
Lead sponsor: Abbott Medical OpticsIndustry (pharma, biotech, devices)
Study start: 30 Sep 2009 (actual)
Primary completion: 30 Nov 2010 (actual)
Study completion: 30 Nov 2010 (actual)
First posted: 7 Sep 2009 (estimated)
Results: Posted 22 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Vitrax II	Experimental	Device: Vitrax IIInvestigational dispersive viscoelastic
Viscoat	Active comparator	Device: ViscoatMarketed control dispersive viscoelastic

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Otherwise healthy eye with no pathology other than the presence of cataract
Visual potential of 20/40 or better

Key exclusion criteria (3 listed)

Taking any medications that affect vision, intraocular pressure or ease of cataract surgery (e.g. flomax, glaucoma medications, etc.)
Known intraocular pressure increases from steroid treatment
Low endothelial cell count

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
Vitrax IIViscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber.	Device	Vitrax II
ViscoatCurrently marketed viscoelastic administered via one or two vials as determined by cataract surgeon for maintenance of anterior chamber..	Device	Viscoat

Primary outcome

Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively
Time frame: 3 months postoperative
Cumulative rate of Intraoperative Pressure (IOP) spikes 30 mm Hg (millimeters of mercury) or greater measured postoperatively through three months.

1 secondary outcome

Postoperative Mean Endothelial Cell Count
Time frame: 3 months postoperative

Results and safety

Results posted to the registry on 22 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitrax II	200	200
Viscoat	200	199

Primary outcome: Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively

Time frame: 3 months postoperative. Number (90% Confidence Interval). Unit: percentage of participants

Measure	Vitrax II n = 199	Viscoat n = 201
Value	10.6 (6.97 to 14.14)	7.6 (4.49 to 10.63)

Population analysed: Results based on Intent-to-Treat (ITT) population (i.e., population based on the intended randomization scheme, which specified 199 Vitrax II subjects and 201 Viscoat subjects). Study statistical analysis plan specified reporting IOP spikes ≥ 30 mmHg for ITT population, which differs from the safety population used in the Participant Flow.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 4.7% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vitrax II	0 of 200 (0%)	21 of 200 (10.5%)	Not reported
Viscoat	0 of 200 (0%)	15 of 200 (7.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitrax II and Viscoat in people with Cataract, run by Abbott Medical Optics at 1 site 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 2 inclusion and 3 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 22 Feb 2012). 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?

Percent of Intraocular Pressure Spikes 30 mm Hg or Greater Postoperatively (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00972621.

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 11 Feb 2025.