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Safety and Effectiveness of the CustomFlex Artificial Iris Prosthesis for the Treatment of Iris Defects

NCT01860612 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-10-24

No results posted yet for this study

Summary

The purpose of this study is to study the long term safety and effectiveness of an artificial iris prosthesis for the treatment of iris defects.

Conditions

  • Full Aniridia
  • Partial Aniridia

Interventions

DEVICE

Artificial Iris (CustomFlex)

Sponsors & Collaborators

  • HumanOptics AG

    collaborator INDUSTRY

  • Clinical Research Consultants, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01860612 on ClinicalTrials.gov