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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
IOL implantation
IOL Implantation
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bausch & Lomb

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IOL implantation

Arm Description

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

Outcomes

Primary Outcome Measures

Visual Acuity
Corrected distance visual acuity (CDVA)

Secondary Outcome Measures

Incision size
Incision size before and after implantation
Refraction
Manifest refraction spherical equivalent. Accuracy to target refraction
Visual Acuity
Uncorrected distance visual acuity (UDVA)
EPCO
3 mm evaluation of posterior capsule opacification (EPCO) score
Lens decentration
Laser capsulotomy
Removal of post-surgical, posterior capsular opacification (PCO)

Full Information

First Posted
May 29, 2012
Last Updated
November 12, 2019
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01615861
Brief Title
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Official Title
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2012 (Actual)
Primary Completion Date
June 16, 2015 (Actual)
Study Completion Date
June 16, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL implantation
Arm Type
Experimental
Arm Description
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
Intervention Type
Procedure
Intervention Name(s)
IOL implantation
Intervention Description
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
Intervention Type
Device
Intervention Name(s)
IOL Implantation
Intervention Description
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.
Primary Outcome Measure Information:
Title
Visual Acuity
Description
Corrected distance visual acuity (CDVA)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incision size
Description
Incision size before and after implantation
Time Frame
6 Months
Title
Refraction
Description
Manifest refraction spherical equivalent. Accuracy to target refraction
Time Frame
6 Months
Title
Visual Acuity
Description
Uncorrected distance visual acuity (UDVA)
Time Frame
6 Months
Title
EPCO
Description
3 mm evaluation of posterior capsule opacification (EPCO) score
Time Frame
24 Months
Title
Lens decentration
Time Frame
6 Months
Title
Laser capsulotomy
Description
Removal of post-surgical, posterior capsular opacification (PCO)
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Bausch & Lomb
City
Labege
ZIP/Postal Code
31670
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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