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Completed

NCT Number: NCT01261975

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

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.

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Key information

Conditions

Cataract Aphakia Eye Diseases Lens Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coaxial Micro-Incision Cataract Surgery

Procedure

1.8 mm coaxial micro incision

Other names: Stellaris Vision Enhancement System

Coaxial Small Incision Cataract Surgery

Procedure

2.75 mm coaxial incision

Other names: Stellaris Vision Enhancement System

Primary outcomes

  1. 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.

Secondary outcomes

  1. Best Corrected Visual Acuity

    Time frame: Visit 1, visit 2, visit 3, visit 4

    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

  2. Best Corrected Visual Acuity

    Time frame: visit 5, visit 6, visit 7, visit 8

    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.

  3. Uncorrected Visual Acuity

    Time frame: Visit 1, visit 2, visit 3, visit 4

    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

  4. Uncorrected Visual Acuity

    Time frame: visit 5, visit 6, visit 7, visit 8

    Uncorrected visual acuity(UCVA) was assessed using logMAR charts. Change from baseline summarized by visit.

  5. Surgically Induced Astigmatism (SIA)

    Time frame: Visits 1-3

    Surgically induced astigmatism was presented in dioptres at each visit.

  6. Surgically Induced Astigmatism (SIA)

    Time frame: Visits 4-8

    Surgically induced astigmatism presented in dioptres at each visit.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2010
Registry last updated
Feb 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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