- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01615861
Evaluation of Clinical Outcomes Following Implantation of a Sub-2mm Hydrophilic MICS Intraocular Lens
November 12, 2019 updated by: Bausch & Lomb Incorporated
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
103
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Labege, France, 31670
- Bausch & Lomb
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IOL implantation
Hydrophilic acrylic lens implantation through a micro-incision phacoemulsification and cataract surgery (MICS)
|
Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Acuity
Time Frame: 6 months
|
Corrected distance visual acuity (CDVA)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incision size
Time Frame: 6 Months
|
Incision size before and after implantation
|
6 Months
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Refraction
Time Frame: 6 Months
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Manifest refraction spherical equivalent.
Accuracy to target refraction
|
6 Months
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Visual Acuity
Time Frame: 6 Months
|
Uncorrected distance visual acuity (UDVA)
|
6 Months
|
EPCO
Time Frame: 24 Months
|
3 mm evaluation of posterior capsule opacification (EPCO) score
|
24 Months
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Lens decentration
Time Frame: 6 Months
|
6 Months
|
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Laser capsulotomy
Time Frame: 24 Months
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Removal of post-surgical, posterior capsular opacification (PCO)
|
24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 8, 2012
Primary Completion (ACTUAL)
June 16, 2015
Study Completion (ACTUAL)
June 16, 2015
Study Registration Dates
First Submitted
May 29, 2012
First Submitted That Met QC Criteria
June 7, 2012
First Posted (ESTIMATE)
June 11, 2012
Study Record Updates
Last Update Posted (ACTUAL)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 714
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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