A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Sponsor
Santen Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02888210
Collaborator
(none)
110
1
1
14.6
7.5
Study Details
Study Description
Brief Summary
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery
Actual Study Start Date
:
Sep 3, 2016
Actual Primary Completion Date
:
Nov 22, 2017
Actual Study Completion Date
:
Nov 22, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MD-15 Investigational intraocular lens |
Device: MD-15 Intraocular Lens
|
Outcome Measures
Primary Outcome Measures
- Corrected visual acuity [Week 52]
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tokyo | Japan |
Sponsors and Collaborators
- Santen Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02888210
Other Study ID Numbers:
- MD151508
First Posted:
Sep 2, 2016
Last Update Posted:
Feb 27, 2018
Last Verified:
Feb 1, 2018