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Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP

NCT02826174 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-07

No results posted yet for this study

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.

Conditions

  • Corneal Opacity
  • Keratitis, Herpetic
  • Corneal Ulcer
  • Corneal Dystrophies, Hereditary

Interventions

PROCEDURE

closed PKP under topical anesthesia

a closed corneal transplantation under topical anesthesia with the anterior chamber maintained

PROCEDURE

open-sky PKP under retrobulbar anesthesia

an open-sky corneal transplantation under retrobulbar anesthesia

DRUG

Anti-Rejection Agents

Anti-Rejection Agents for both groups

DRUG

Anti-Inflammatory Agents

Anti-Inflammatory Agents for both groups

Sponsors & Collaborators

  • Wenzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • China

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 NCT02826174 on ClinicalTrials.gov