CataractPhase 4NCT01261975

Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

A Phase 4 study testing Coaxial Micro-Incision Cataract Surgery and Coaxial Small Incision Cataract Surgery in people with Cataract and Aphakia, run by Bausch & Lomb Incorporated.

Completed

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

Official record

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Trial summary

The objective of this study is to test the hypothesis that the time to reach a stable refraction is significantly shorter in eyes operated with the 1.8 mm coaxial microincision compared to eyes operated with the 2.75 mm standard incision using the Stellaris Vision Enhancement System. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Cataract, Aphakia
What is being tested?: Coaxial Micro-Incision Cataract Surgery and Coaxial Small Incision Cataract Surgery
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Aug 2009to Jul 2010
Phase: Phase 4
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
Subject's ocular media must be clear except for the presence of the cataract in both eyes.

Who cannot join

Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.

About this study

Official title: Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System

Conditions: Cataract, Aphakia
Being tested: Coaxial Micro-Incision Cataract Surgery, Coaxial Small Incision Cataract Surgery
Keywords: Ocular Surgery, Intraocular Lens
Medical subject headings: Cataract, Aphakia

What participants receive

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

Coaxial Micro-Incision Cataract SurgeryProcedure or surgery
Also called Stellaris Vision Enhancement System
1.8 mm coaxial micro incision
Coaxial Small Incision Cataract SurgeryProcedure or surgery
Also called Stellaris Vision Enhancement System
2.75 mm coaxial incision

Study groups in NCT01261975
Study group	Role	What they receive
Coaxial Micro-Incision Cataract Surgery	Experimental	1.8 mm coaxial microincision Receives: Procedure: Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract Surgery	Active comparator	2.75 mm standard incision Receives: Procedure: Coaxial Small Incision Cataract Surgery

What is being measured

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

Refractive Stability
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.
Measured: 12 weeks

Secondary outcomes (6)

Best Corrected Visual Acuity
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from preoperative visit summarized by visit. A minus change represents an improvement of the visual acuity
Measured: Visit 1, visit 2, visit 3, visit 4
Best Corrected Visual Acuity
Best corrected distance visual acuity(BCVA) was assessed using logMAR charts. Change from baseline summarized by visit. A minus change represents an improvement of the visual acuity.
Measured: visit 5, visit 6, visit 7, visit 8
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Measured: Visit 1, visit 2, visit 3, visit 4
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Measured: visit 5, visit 6, visit 7, visit 8
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism was presented in dioptres at each visit.
Measured: Visits 1-3
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism presented in dioptres at each visit.
Measured: Visits 4-8

Timeline

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

Aug 2009Jul 2010

First posted17 Dec 2010 (estimated)
Study startAug 2009
Primary completionApr 2010
Study completionJul 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01261975
Sponsor's protocol ID: 607
Status last verified: Jan 2012
First submitted: 15 Dec 2010
Last updated: 27 Feb 2012
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?

Official record

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
ClinicalTrials.gov ID: NCT01261975
Acronym / sponsor ID: 607
Conditions: Cataract, Aphakia
Keywords: Ocular Surgery, Intraocular Lens
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Apr 2010 (actual)
Study completion: Jul 2010 (actual)
First posted: 17 Dec 2010 (estimated)
Results: Posted 27 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: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Coaxial Micro-Incision Cataract Surgery	Experimental	Procedure: Coaxial Micro-Incision Cataract Surgery1.8 mm coaxial microincision
Coaxial Small Incision Cataract Surgery	Active comparator	Procedure: Coaxial Small Incision Cataract Surgery2.75 mm standard incision

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects must be undergoing bilateral primary in-the-bag intraocular lens (IOL) implantation for the correction of aphakia.
Subject's ocular media must be clear except for the presence of the cataract in both eyes.

Key exclusion criteria (1 listed)

Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of 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
Coaxial Micro-Incision Cataract SurgeryAlso: Stellaris Vision Enhancement System1.8 mm coaxial micro incision	Procedure or surgery	Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract SurgeryAlso: Stellaris Vision Enhancement System2.75 mm coaxial incision	Procedure or surgery	Coaxial Small Incision Cataract Surgery

Primary outcome

Refractive Stability
Time frame: 12 weeks
Cumulative portion of eyes achieving refractive stability within 0.5 D of the final value for the remainder of the trial by surgical procedure and visit.

6 secondary outcomes

Best Corrected Visual Acuity
Time frame: Visit 1, visit 2, visit 3, visit 4
Best Corrected Visual Acuity
Time frame: visit 5, visit 6, visit 7, visit 8
Uncorrected Visual Acuity
Time frame: Visit 1, visit 2, visit 3, visit 4
Uncorrected Visual Acuity
Time frame: visit 5, visit 6, visit 7, visit 8
Surgically Induced Astigmatism (SIA)
Time frame: Visits 1-3
Surgically Induced Astigmatism (SIA)
Time frame: Visits 4-8

Results and safety

Results posted to the registry on 27 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
Cataract Surgery	36	35

Primary outcome: Refractive Stability

Time frame: 12 weeks. Number. Unit: Eyes

Measure	Coaxial Micro-Incision Cataract Surgery n = 36	Coaxial Small-Incision Cataract Surgery n = 35
Visit 1	17	23
Visit 2	25	25
Visit 3	27	27
Visit 4	27	28
Visit 5	28	30
Visit 6	29	31
Visit 7	29	33

Population analysed: Cumulative Proportion of Eyes Achieving Refractive Stability (within 0.5 D)- Full analysis Set (FAS) Population

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Co-Axial Micro-Incision Cataract Surgery	1 of 36 (2.8%)	33 of 36 (91.7%)	Not reported
Coaxial Small-Incision Cataract Surgery	0 of 35 (0%)	33 of 35 (94.3%)	Not reported
Cataract Surgery All Participants	5 of 36 (13.9%)	66 of 71 (93%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cataract

Recruiting
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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
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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.

Anne Williart, MD study director

Bausch & Lomb Incorporated

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Coaxial Micro-Incision Cataract Surgery and Coaxial Small Incision Cataract Surgery in people with Cataract and Aphakia, run by Bausch & Lomb Incorporated.

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 1 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 27 Feb 2012. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 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?

Refractive Stability (time frame: 12 weeks). 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 NCT01261975.

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 27 Feb 2012.