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

NCT ID: NCT01615861

Last Updated: 2019-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-08

Study Completion Date

2015-06-16

Brief Summary

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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

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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IOL implantation

Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)

Group Type EXPERIMENTAL

IOL implantation

Intervention Type PROCEDURE

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

IOL Implantation

Intervention Type DEVICE

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

Interventions

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IOL implantation

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

Intervention Type PROCEDURE

IOL Implantation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bausch & Lomb

Labège, , France

Site Status

Countries

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France

Other Identifiers

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714

Identifier Type: -

Identifier Source: org_study_id

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