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Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

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ClinicalTrials.gov Identifier: NCT01615861
Recruitment Status : Unknown
Verified March 2014 by Bausch & Lomb Incorporated.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2012
Last Update Posted : March 28, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The objective of this study is to evaluate clinical outcomes following sub-2 mm micro-incision cataract surgery (MICS) and intraocular lens (IOL) implantation. This study is evaluated in two Phases

  • V4 (6M) endpoint: primary analysis
  • V5 (12M) and V6 (34M): EPCO score and Nd Yag incidence analysis

Condition or disease Intervention/treatment Phase
Cataract Procedure: IOL implantation Device: IOL Implantation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Study Start Date : November 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: IOL implantation
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
 Procedure: IOL implantation
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
Device: IOL Implantation
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.


Outcome Measures
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Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: 6 months ]
    Corrected distance visual acuity (CDVA)


Secondary Outcome Measures :
  1. Incision size [ Time Frame: 6 Months ]
    Incision size before and after implantation

  2. Refraction [ Time Frame: 6 Months ]
    Manifest refraction spherical equivalent. Accuracy to target refraction

  3. Visual Acuity [ Time Frame: 6 Months ]
    Uncorrected distance visual acuity (UDVA)

  4. EPCO [ Time Frame: 24 Months ]
    3 mm evaluation of posterior capsule opacification (EPCO) score

  5. Lens decentration [ Time Frame: 6 Months ]
  6. Laser capsulotomy [ Time Frame: 24 Months ]
    Removal of post-surgical, posterior capsular opacification (PCO)


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have clear intraocular media other than cataract in the study eye.
  • Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with micro-incision phacoemulsification cataract extraction in the study eye.

Exclusion Criteria:

  • Subjects with ocular malformation in the study eye.
  • Subjects who have had previous surgery in the study eye.
  • Subjects with uncontrolled glaucoma in either eye.
  • Subjects with any anterior segment pathology for which micro-incision phacoemulsification cataract surgery would be contraindicated
  • Subjects using medications known to potentially complicate cataract surgery.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615861


Locations
France
Bausch & Lomb
Labege, France, 31670
Sponsors and Collaborators
Bausch & Lomb Incorporated
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01615861     History of Changes
Other Study ID Numbers: 714
First Posted: June 11, 2012    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases