Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
1 other identifier
interventional
36
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2009
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedResults Posted
Study results publicly available
February 27, 2012
CompletedFebruary 27, 2012
January 1, 2012
8 months
December 15, 2010
September 21, 2011
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Secondary Outcomes (6)
Best Corrected Visual Acuity
Visit 1, visit 2, visit 3, visit 4
Best Corrected Visual Acuity
visit 5, visit 6, visit 7, visit 8
Uncorrected Visual Acuity
Visit 1, visit 2, visit 3, visit 4
Uncorrected Visual Acuity
visit 5, visit 6, visit 7, visit 8
Surgically Induced Astigmatism (SIA)
Visits 1-3
- +1 more secondary outcomes
Study Arms (2)
Coaxial Micro-Incision Cataract Surgery
EXPERIMENTAL1.8 mm coaxial microincision
Coaxial Small Incision Cataract Surgery
ACTIVE COMPARATOR2.75 mm standard incision
Interventions
1.8 mm coaxial micro incision
2.75 mm coaxial incision
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Omid Khodai
- Organization
- Bausch & Lomb
Study Officials
- STUDY DIRECTOR
Anne Williart, MD
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2010
First Posted
December 17, 2010
Study Start
August 1, 2009
Primary Completion
April 1, 2010
Study Completion
July 1, 2010
Last Updated
February 27, 2012
Results First Posted
February 27, 2012
Record last verified: 2012-01