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Trial record 13 of 432 for:    cataract AND intraocular lens

A Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02888210
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical Co., Ltd.

Brief Summary:
To evaluate safety and efficacy of MD-15 intraocular lens implanted into the aphakic eyes

Condition or disease Intervention/treatment Phase
Cataract Device: MD-15 Intraocular Lens Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
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 : September 3, 2016
Actual Primary Completion Date : November 22, 2017
Actual Study Completion Date : November 22, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: MD-15
Investigational intraocular lens
Device: MD-15 Intraocular Lens



Primary Outcome Measures :
  1. Corrected visual acuity [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888210


Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Santen Pharmaceutical Co., Ltd.

Responsible Party: Santen Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02888210     History of Changes
Other Study ID Numbers: MD151508
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Cataract
Capsule Opacification
Lens Diseases
Eye Diseases