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

NCT02826174 | Unknown

• 1 other identifier: Closed PKP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Study Arms (4)

closed PKP under topical anesthesia

EXPERIMENTAL

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

Procedure: closed PKP under topical anesthesia; Drug: Anti-Rejection Agents; Drug: Anti-Inflammatory Agents

open-sky PKP under retrobulbar anesthesia

ACTIVE COMPARATOR

an open-sky corneal transplantation under retrobulbar anesthesia

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

Anti-Rejection Agents

OTHER

Anti-Rejection Agents for both groups

Procedure: closed PKP under topical anesthesia; Procedure: open-sky PKP under retrobulbar anesthesia

Anti-Inflammatory Agents

OTHER

Anti-Inflammatory Agents for both groups

Procedure: closed PKP under topical anesthesia; Procedure: open-sky PKP under retrobulbar anesthesia

Interventions

closed PKP under topical anesthesia PROCEDURE

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

Anti-Inflammatory Agents; Anti-Rejection Agents; closed PKP under topical anesthesia

open-sky PKP under retrobulbar anesthesia PROCEDURE

an open-sky corneal transplantation under retrobulbar anesthesia

Anti-Inflammatory Agents; Anti-Rejection Agents; open-sky PKP under retrobulbar anesthesia

Anti-Rejection Agents DRUG

Anti-Rejection Agents for both groups

closed PKP under topical anesthesia; open-sky PKP under retrobulbar anesthesia

Anti-Inflammatory Agents DRUG

Anti-Inflammatory Agents for both groups

closed PKP under topical anesthesia; open-sky PKP under retrobulbar anesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

Related 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.

  PMID: 23860425 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Anti-Inflammatory Agents

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Infections, Viral; Eye Infections; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: July 7, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 7, 2016

Record last verified: 2016-07

Locations

CN (1)