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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Corneal Opacity Keratitis, Herpetic Corneal Ulcer Corneal Dystrophies, Hereditary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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closed PKP under topical anesthesia

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

Intervention Type PROCEDURE

open-sky PKP under retrobulbar anesthesia

an open-sky corneal transplantation under retrobulbar anesthesia

Intervention Type PROCEDURE

Anti-Rejection Agents

Anti-Rejection Agents for both groups

Intervention Type DRUG

Anti-Inflammatory Agents

Anti-Inflammatory Agents for both groups

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No