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

Sponsor

Wenzhou Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02826174

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Opacity Keratitis, Herpetic Corneal Ulcer Corneal Dystrophies, Hereditary	Procedure: closed PKP under topical anesthesia Procedure: open-sky PKP under retrobulbar anesthesia Drug: Anti-Rejection Agents Drug: Anti-Inflammatory Agents	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: closed PKP under topical anesthesia a closed corneal transplantation under topical anesthesia with the anterior chamber maintained	Procedure: closed PKP under topical anesthesia a closed corneal transplantation under topical anesthesia with the anterior chamber maintained Drug: Anti-Rejection Agents Anti-Rejection Agents for both groups Drug: Anti-Inflammatory Agents Anti-Inflammatory Agents for both groups
Active Comparator: open-sky PKP under retrobulbar anesthesia an open-sky corneal transplantation under retrobulbar anesthesia	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
Other: Anti-Rejection Agents Anti-Rejection Agents for both groups	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
Other: Anti-Inflammatory Agents Anti-Inflammatory Agents for both groups	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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Endothelial cell density [1 week after PKP]
Endothelial cell density [2 weeks after PKP]
Endothelial cell density [1 month after PKP]
Endothelial cell density [3 months after PKP]
Endothelial cell density [6 months after PKP]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.