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OpenTrials
Completed

NCT Number: NCT01615861

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb

Labège, 31670, France

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

IOL implantation

Procedure

Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.

IOL Implantation

Device

Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.

Primary outcomes

  1. Visual Acuity

    Time frame: 6 months

    Corrected distance visual acuity (CDVA)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2012
Registry last updated
Nov 14, 2019

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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