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

Wenzhou Medical University

Status: Unknown

Conditions: Corneal Opacity; Corneal Dystrophies, Hereditary; Corneal Ulcer; Keratitis, Herpetic

Treatments: Drug: Anti-Rejection Agents; Procedure: open-sky PKP under retrobulbar anesthesia; Procedure: closed PKP under topical anesthesia; Drug: Anti-Inflammatory Agents

Study type: Interventional

Funder types: Other

Identifiers

NCT02826174

Closed PKP

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

closed PKP under topical anesthesia

Experimental group

Description:

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

Treatment:

Procedure: closed PKP under topical anesthesia

Drug: Anti-Inflammatory Agents

Drug: Anti-Rejection Agents

open-sky PKP under retrobulbar anesthesia

Active Comparator group

Description:

an open-sky corneal transplantation under retrobulbar anesthesia

Treatment:

Procedure: open-sky PKP under retrobulbar anesthesia

Drug: Anti-Inflammatory Agents

Drug: Anti-Rejection Agents

Anti-Rejection Agents

Other group

Description:

Anti-Rejection Agents for both groups

Treatment:

Procedure: closed PKP under topical anesthesia

Procedure: open-sky PKP under retrobulbar anesthesia

Anti-Inflammatory Agents

Other group

Description:

Anti-Inflammatory Agents for both groups

Treatment:

Procedure: closed PKP under topical anesthesia

Procedure: open-sky PKP under retrobulbar anesthesia