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

Not Applicable

• Conditions: Corneal Opacity; Corneal Dystrophies, Hereditary; Corneal Ulcer; Keratitis, Herpetic
• Interventions: Procedure: closed PKP under topical anesthesia; Procedure: open-sky PKP under retrobulbar anesthesia; Drug: Anti-Rejection Agents; Drug: Anti-Inflammatory Agents

• Registration Number: NCT02826174
• Lead Sponsor: Wenzhou Medical University

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 Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-06-21
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-04
• Last Update Submitted: 2016-07-04
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• active bacterial keratitis, for which ulceration progressed despite maximum antibacterial medication;
• refractory fungal keratitis that did not respond to antifungal agents;
• nonactive HSK, for which corneal opacities with or without new vessels involved the optical zone;
• ocular acid burn and thermal burn with partial limbal deficiency (50% or less) that, after more than half a year of preoperative treatment, showed reepithelialization and less than 2 quadrants limbal neovascularization.

Exclusion Criteria

• Patients with keratolimbal allograft transplantation, total limbal stem cell deficiency secondary to ocular burns, and other ocular diseases (ie, amblyopia, age-related cataract, glaucoma, macular edema, and mac ular degeneration) were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open-sky PKP under retrobulbar anesthesia	Anti-Inflammatory Agents	an open-sky corneal transplantation under retrobulbar anesthesia
closed PKP under topical anesthesia	closed PKP under topical anesthesia	a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
open-sky PKP under retrobulbar anesthesia	open-sky PKP under retrobulbar anesthesia	an open-sky corneal transplantation under retrobulbar anesthesia
closed PKP under topical anesthesia	Anti-Inflammatory Agents	a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
open-sky PKP under retrobulbar anesthesia	Anti-Rejection Agents	an open-sky corneal transplantation under retrobulbar anesthesia
Anti-Inflammatory Agents	closed PKP under topical anesthesia	Anti-Inflammatory Agents for both groups
Anti-Inflammatory Agents	open-sky PKP under retrobulbar anesthesia	Anti-Inflammatory Agents for both groups
closed PKP under topical anesthesia	Anti-Rejection Agents	a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
Anti-Rejection Agents	closed PKP under topical anesthesia	Anti-Rejection Agents for both groups
Anti-Rejection Agents	open-sky PKP under retrobulbar anesthesia	Anti-Rejection Agents for both groups

Primary Outcome Measures

Name	Time	Method
best corrected visual acuity	6 months after PKP

Secondary Outcome Measures

Name	Time	Method
Endothelial cell density	6 months after PKP

Trial Locations

Locations (1)

Eye Hospital, Wenzhou Medical College; 🇨🇳 Wenzhou, Zhejiang, China