Clinical Trial: Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: Penetrating keratoplasty (PKP) is an open-sky surgery that fundamentally has not changed for more than 100 years. Because conventional PKP is associated with the potential for the development of devastating complications such as expulsive suprachoroidal hemorrhage and endophthalmitis, we modified the technique to one that is a closed surgery under topical anesthesia with the anterior chamber maintained to achieve favorable results. Topical anesthesia is an attractive alternative to traditional injection local anesthesia since the potentially serious complications associated with retrobulbar and peribulbar anesthesia can be avoided. The closed PKP procedure with the stable anterior chamber essentially changes the open nature of conventional PKP. The advantages, i.e., decreased surgical risks, postoperative complications, and surgical difficulties, make PKP viable in most complicated cases.

Detailed Summary:
Sponsor: Wenzhou Medical University

Current Primary Outcome:

  • best corrected visual acuity [ Time Frame: preoperative ]
  • best corrected visual acuity [ Time Frame: 1 week after PKP ]
  • best corrected visual acuity [ Time Frame: 2 weeks after PKP ]
  • best corrected visual acuity [ Time Frame: 1 month after PKP ]
  • best corrected visual acuity [ Time Frame: 3 months after PKP ]
  • best corrected visual acuity [ Time Frame: 6 months after PKP ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Endothelial cell density [ Time Frame: 1 week after PKP ]
  • Endothelial cell density [ Time Frame: 2 weeks after PKP ]
  • Endothelial cell density [ Time Frame: 1 month after PKP ]
  • Endothelial cell density [ Time Frame: 3 months after PKP ]
  • Endothelial cell density [ Time Frame: 6 months after PKP ]


Original Secondary Outcome: Same as current

Information By: Wenzhou Medical University

Dates:
Date Received: June 21, 2016
Date Started: December 2015
Date Completion: December 2016
Last Updated: July 4, 2016
Last Verified: July 2016