NCT03812341

SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 88 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. However, this expanded access is for single patient use below is a description of patient condition and circumstances necessitating treatment: 88 year old female with 2 previous failed corneal transplants, had significant scarring and mild edema, surface well epithelialized, has potential for 10 letters of improvement in visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore would not be a candidate for standard corneal transplant. She would potentially do well with a partial thickness artificial cornea such as the KeraKlear.

Detailed description

For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old as of the submission of this Protocol Narrative to the IRB. Postoperatively, subject will be examined at (with window size in parentheses): * 1 Day (+2 days) * 1 Week (7±2 days) * 1 Month (30±5 days) * 2 Months (60±7 days) * 3 Months (90±7 days) * 4 Months (120±10 days) * 6 Months (180±10 days) * 9 Months (270±20 days) * 12 Months (360±20 days)

Conditions

• CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT

Interventions

Type	Name	Description
OTHER	Experimental	KeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity

Timeline

• Start date: 2018-08-10
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2019-01-23
• Last updated: 2020-05-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study