NCT01615861

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

November 8, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2015

Completed
Last Updated

November 14, 2019

Status Verified

November 1, 2019

Enrollment Period

2.6 years

First QC Date

May 29, 2012

Last Update Submit

November 12, 2019

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Corrected distance visual acuity (CDVA)

    6 months

Secondary Outcomes (6)

  • Incision size

    6 Months

  • Refraction

    6 Months

  • Visual Acuity

    6 Months

  • EPCO

    24 Months

  • Lens decentration

    6 Months

  • +1 more secondary outcomes

Study Arms (1)

IOL implantation

EXPERIMENTAL

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

Procedure: IOL implantationDevice: IOL Implantation

Interventions

IOL ImplantationPROCEDURE

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

IOL implantation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb

Labège, 31670, France

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2012

First Posted

June 11, 2012

Study Start

November 8, 2012

Primary Completion

June 16, 2015

Study Completion

June 16, 2015

Last Updated

November 14, 2019

Record last verified: 2019-11

Locations

FR(1)