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
  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:


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
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

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014