- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02888210
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
February 25, 2018 updated by: Santen Pharmaceutical Co., Ltd.
Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
Study Overview
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Phase 3
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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Tokyo, Japan
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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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who intend to undergo phacoemulsification cataract extraction
Exclusion Criteria:
- Patients who undergo secondary implantation
- Patients with vision loss induced by causes other than cataract
- Patients who the principal investigator/subinvestigator considers ineligible for enrollment
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MD-15
Investigational intraocular lens
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Corrected visual acuity
Time Frame: Week 52
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Week 52
|
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)
September 3, 2016
Primary Completion (Actual)
November 22, 2017
Study Completion (Actual)
November 22, 2017
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 2, 2016
Study Record Updates
Last Update Posted (Actual)
February 27, 2018
Last Update Submitted That Met QC Criteria
February 25, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD151508
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.
Clinical Trials on Cataract
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Fundación Pública Andaluza para la Investigación...CompletedCataract | Cataract Mature | Cataract, Nuclear
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Omer Othman AbdullahCompletedCongenital Cataract | Pediatric CataractIraq
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Johannes Kepler University of LinzRecruitingAphakia | Secondary Cataract Surgery | Complicated Cataract SurgeryAustria
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Yonsei UniversityCompletedCataract PatientsKorea, Republic of
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Advanced Center for Eyecare GlobalNot yet recruiting
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Vienna Institute for Research in Ocular SurgeryRecruiting
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Clinical Trials on MD-15 Intraocular Lens
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Abbott Medical OpticsCompletedCataractUnited States, United Kingdom
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VA Office of Research and DevelopmentCompleted
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Lenstec IncorporatedCompletedPresbyopia | CataractsUnited States
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University of PittsburghCompletedGlaucoma | Cataract | Age Related Macular Degeneration | Age-related Cataract | Circadian Rhythm DisordersUnited States
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Samsung Medical CenterCompleted