Clinical Trial: Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Hyperopia Correction Using the NTK Optimal Keratoplasty (Opti-K) System

Brief Summary: The purpose of this U.S. Clinical Trial on treatment of sighted eyes is to investigate the safety and effectiveness of optimal keratoplasty (Opti-K™) treatments for hyperopia correction using the NTK Enterprises (NTK) Opti-K System.

Detailed Summary:
Sponsor: NTK Enterprises, Inc.

Current Primary Outcome: The proportion of eyes (target: at least 85%) that achieve successful distance uncorrected visual acuity (D-UCVA) improvement defined as 2 lines (10 letters) or more improvement in D-UCVA following Tx will be reported. [ Time Frame: 1 year post-treatment ]

Original Primary Outcome:

Current Secondary Outcome: The proportion of eyes that achieve distance uncorrected visual acuity (D-UCVA) of 20/40 or better following Tx and the proportion of eyes that achieve D-UCVA of 20/40 or better as a function of the pre-Tx D-UCVA will both be reported. [ Time Frame: 1 year post-treatment ]

Original Secondary Outcome:

Information By: NTK Enterprises, Inc.

Dates:
Date Received: December 8, 2009
Date Started: December 2009
Date Completion: October 2018
Last Updated: January 23, 2017
Last Verified: January 2017