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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261975
• Other study ID #: 607
• Status: Completed
• Phase: Phase 4
• First received: December 15, 2010
• Last updated: January 24, 2012
• Start date: August 2009
• Est. completion date: July 2010

Study information

• Verified date: January 2012
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aphakia
• Cataract

Intervention

Procedure:
• Coaxial Micro-Incision Cataract Surgery
1.8 mm coaxial micro incision
• Coaxial Small Incision Cataract Surgery
2.75 mm coaxial incision

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Visit 1, visit 2, visit 3, visit 4	No
Secondary	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.	visit 5, visit 6, visit 7, visit 8	No
Secondary	Uncorrected Visual Acuity	Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.	Visit 1, visit 2, visit 3, visit 4	No
Secondary	Uncorrected Visual Acuity	Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.	visit 5, visit 6, visit 7, visit 8	No
Secondary	Surgically Induced Astigmatism (SIA)	Surgically induced astigmatism was presented in dioptres at each visit.	Visits 1-3	No
Secondary	Surgically Induced Astigmatism (SIA)	Surgically induced astigmatism presented in dioptres at each visit.	Visits 4-8	No