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

Cataract Clinical Trial

Official title:

Open Label, Phase/3 Study Assessing Safety and Efficacy of MD-15 Intraocular Lens in Patients With Aphakic Eye After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888210
• Other study ID #: MD151508
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2016
• Last updated: February 25, 2018
• Start date: September 3, 2016
• Est. completion date: November 22, 2017

Study information

• Verified date: February 2018
• Source: Santen Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 22, 2017
• Est. primary completion date: November 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract

Intervention

Device:
• MD-15 Intraocular Lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Santen Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corrected visual acuity		Week 52