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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01615861
First received: May 29, 2012
Last updated: March 27, 2014
Last verified: March 2014
History of Changes
  Purpose

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 Intervention Phase
Cataract
 Procedure: IOL implantation
Device: IOL Implantation
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Corrected distance visual acuity (CDVA)


Secondary Outcome Measures:
  • Incision size [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Incision size before and after implantation

  • Refraction [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Manifest refraction spherical equivalent. Accuracy to target refraction

  • Visual Acuity [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Uncorrected distance visual acuity (UDVA)

  • EPCO [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    3 mm evaluation of posterior capsule opacification (EPCO) score

  • Lens decentration [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Laser capsulotomy [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Removal of post-surgical, posterior capsular opacification (PCO)
Enrollment: 103
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility
Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615861

Locations
France
Bausch & Lomb
Labege, France, 31670
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01615861     History of Changes
Other Study ID Numbers: 714
Study First Received: May 29, 2012
Last Updated: March 27, 2014
Health Authority: Sweden: Regional Ethical Review Board

ClinicalTrials.gov processed this record on February 27, 2015