Evaluation of Clinical Outcomes Following Implantation of... | NCT01615861

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

NCT01615861

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Nov 14, 2019Actual

Enrollment

103Actual

Phase

Not Applicable

Conditions

Cataract

Interventions

IOL implantation
IOL Implantation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2012Actual

Primary Completion Date

Jun 16, 2015Actual

Completion Date

Jun 16, 2015Actual

First Submitted Date

May 29, 2012

First Submission Date that Met QC Criteria

Jun 7, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 12, 2019

Last Update Posted Date

Nov 14, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IOL implantation	Experimental	Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)	Procedure: IOL implantation Device: IOL Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IOL implantation	Procedure	Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.	IOL implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Acuity	Corrected distance visual acuity (CDVA)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Incision size	Incision size before and after implantation	6 Months
Refraction	Manifest refraction spherical equivalent. Accuracy to target refraction

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases