Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Primary Purpose
Cataract, Aphakia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Ocular Surgery, Intraocular Lens
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coaxial Micro-Incision Cataract Surgery
Coaxial Small Incision Cataract Surgery
Arm Description
1.8 mm coaxial microincision
2.75 mm standard incision
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Uncorrected Visual Acuity
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism was presented in dioptres at each visit.
Surgically Induced Astigmatism (SIA)
Surgically induced astigmatism presented in dioptres at each visit.
Full Information
NCT ID
NCT01261975
First Posted
December 15, 2010
Last Updated
January 24, 2012
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01261975
Brief Title
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Official Title
Co-Axial Micro-incision Cataract Surgery(C-MICS) Versus Standard Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Aphakia
Keywords
Ocular Surgery, Intraocular Lens
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaxial Micro-Incision Cataract Surgery
Arm Type
Experimental
Arm Description
1.8 mm coaxial microincision
Arm Title
Coaxial Small Incision Cataract Surgery
Arm Type
Active Comparator
Arm Description
2.75 mm standard incision
Intervention Type
Procedure
Intervention Name(s)
Coaxial Micro-Incision Cataract Surgery
Other Intervention Name(s)
Stellaris Vision Enhancement System
Intervention Description
1.8 mm coaxial micro incision
Intervention Type
Procedure
Intervention Name(s)
Coaxial Small Incision Cataract Surgery
Other Intervention Name(s)
Stellaris Vision Enhancement System
Intervention Description
2.75 mm coaxial incision
Primary Outcome Measure Information:
Title
Refractive Stability
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
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
Time Frame
Visit 1, visit 2, visit 3, visit 4
Title
Best Corrected Visual Acuity
Description
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.
Time Frame
visit 5, visit 6, visit 7, visit 8
Title
Uncorrected Visual Acuity
Description
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time Frame
Visit 1, visit 2, visit 3, visit 4
Title
Uncorrected Visual Acuity
Description
Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.
Time Frame
visit 5, visit 6, visit 7, visit 8
Title
Surgically Induced Astigmatism (SIA)
Description
Surgically induced astigmatism was presented in dioptres at each visit.
Time Frame
Visits 1-3
Title
Surgically Induced Astigmatism (SIA)
Description
Surgically induced astigmatism presented in dioptres at each visit.
Time Frame
Visits 4-8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Subject with any disease, which, in the Investigator's opinion, might interfere with the conduct of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Williart, MD
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Co-Axial Micro-Incision Versus Co-Axial Small Incision Cataract Surgery Using the Stellaris Enhancement System
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