Back to resultsA Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
MD-15 Intraocular Lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MD-15
Arm Description
Investigational intraocular lens
Outcomes
Primary Outcome Measures
Corrected visual acuity
Secondary Outcome Measures
Full Information
NCT ID
NCT02888210
First Posted
August 30, 2016
Last Updated
February 25, 2018
Sponsor
Santen Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02888210
Brief Title
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Official Title
Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 3, 2016 (Actual)
Primary Completion Date
November 22, 2017 (Actual)
Study Completion Date
November 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
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
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MD-15
Arm Type
Experimental
Arm Description
Investigational intraocular lens
Intervention Type
Device
Intervention Name(s)
MD-15 Intraocular Lens
Primary Outcome Measure Information:
Title
Corrected visual acuity
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
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