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

Corneal Ulcer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02826174
• Other study ID #: Closed PKP
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2016
• Last updated: July 4, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Health and Family Planning Commission of Zhejiang Province
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Corneal Opacity
• Corneal Ulcer
• Keratitis
• Keratitis, Herpetic

Intervention

Procedure:
• closed PKP under topical anesthesia
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
• open-sky PKP under retrobulbar anesthesia
an open-sky corneal transplantation under retrobulbar anesthesia

Drug:
• Anti-Rejection Agents
Anti-Rejection Agents for both groups
• Anti-Inflammatory Agents
Anti-Inflammatory Agents for both groups

Locations

Country	Name	City	State
China	Eye Hospital, Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	best corrected visual acuity		preoperative	Yes
Primary	best corrected visual acuity		1 week after PKP	Yes
Primary	best corrected visual acuity		2 weeks after PKP	Yes
Primary	best corrected visual acuity		1 month after PKP	Yes
Primary	best corrected visual acuity		3 months after PKP	Yes
Primary	best corrected visual acuity		6 months after PKP	Yes
Secondary	Endothelial cell density		1 week after PKP	Yes
Secondary	Endothelial cell density		2 weeks after PKP	Yes
Secondary	Endothelial cell density		1 month after PKP	Yes
Secondary	Endothelial cell density		3 months after PKP	Yes
Secondary	Endothelial cell density		6 months after PKP	Yes