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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • Recruiting
      • Eye Hospital, Wenzhou Medical College
      • Contact: qian gui, MD; Phone Number: 8613600643736; Email: 389997168@qq.com
      • Contact: qinxiang zheng, PhD; Phone Number: 8613738379810
      • Principal Investigator: Jinyang Li, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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	Drug: Anti-Rejection Agents; Anti-Rejection Agents for both groups; Drug: Anti-Inflammatory Agents; Anti-Inflammatory Agents for both groups; Procedure: open-sky PKP under retrobulbar anesthesia; an open-sky corneal transplantation under retrobulbar anesthesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Wenzhou Medical University

Publications and helpful links

General Publications

• Chen W, Ren Y, Zheng Q, Li J, Waller SG. Securing the anterior chamber in penetrating keratoplasty: an innovative surgical technique. Cornea. 2013 Sep;32(9):1291-5. doi: 10.1097/ICO.0b013e31829954c5.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: July 4, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Eye Diseases; Genetic Diseases, Inborn; DNA Virus Infections; Eye Diseases, Hereditary; Corneal Diseases; Herpesviridae Infections; Eye Infections; Eye Infections, Viral; Herpes Simplex; Corneal Opacity; Keratitis; Corneal Dystrophies, Hereditary; Keratitis, Herpetic; Corneal Ulcer; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Anti-Inflammatory Agents
• Other Study ID Numbers: Closed PKP