Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
Primary Purpose
Corneal Opacity, Keratitis, Herpetic, Corneal Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
closed PKP under topical anesthesia
open-sky PKP under retrobulbar anesthesia
Anti-Rejection Agents
Anti-Inflammatory Agents
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Opacity
Eligibility Criteria
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.
Sites / Locations
- Eye Hospital, Wenzhou Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Other
Other
Arm Label
closed PKP under topical anesthesia
open-sky PKP under retrobulbar anesthesia
Anti-Rejection Agents
Anti-Inflammatory Agents
Arm Description
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
an open-sky corneal transplantation under retrobulbar anesthesia
Anti-Rejection Agents for both groups
Anti-Inflammatory Agents for both groups
Outcomes
Primary Outcome Measures
best corrected visual acuity
best corrected visual acuity
best corrected visual acuity
best corrected visual acuity
best corrected visual acuity
best corrected visual acuity
Secondary Outcome Measures
Endothelial cell density
Endothelial cell density
Endothelial cell density
Endothelial cell density
Endothelial cell density
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02826174
Brief Title
Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Opacity, Keratitis, Herpetic, Corneal Ulcer, Corneal Dystrophies, Hereditary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
closed PKP under topical anesthesia
Arm Type
Experimental
Arm Description
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
Arm Title
open-sky PKP under retrobulbar anesthesia
Arm Type
Active Comparator
Arm Description
an open-sky corneal transplantation under retrobulbar anesthesia
Arm Title
Anti-Rejection Agents
Arm Type
Other
Arm Description
Anti-Rejection Agents for both groups
Arm Title
Anti-Inflammatory Agents
Arm Type
Other
Arm Description
Anti-Inflammatory Agents for both groups
Intervention Type
Procedure
Intervention Name(s)
closed PKP under topical anesthesia
Intervention Description
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
Intervention Type
Procedure
Intervention Name(s)
open-sky PKP under retrobulbar anesthesia
Intervention Description
an open-sky corneal transplantation under retrobulbar anesthesia
Intervention Type
Drug
Intervention Name(s)
Anti-Rejection Agents
Intervention Description
Anti-Rejection Agents for both groups
Intervention Type
Drug
Intervention Name(s)
Anti-Inflammatory Agents
Intervention Description
Anti-Inflammatory Agents for both groups
Primary Outcome Measure Information:
Title
best corrected visual acuity
Time Frame
preoperative
Title
best corrected visual acuity
Time Frame
1 week after PKP
Title
best corrected visual acuity
Time Frame
2 weeks after PKP
Title
best corrected visual acuity
Time Frame
1 month after PKP
Title
best corrected visual acuity
Time Frame
3 months after PKP
Title
best corrected visual acuity
Time Frame
6 months after PKP
Secondary Outcome Measure Information:
Title
Endothelial cell density
Time Frame
1 week after PKP
Title
Endothelial cell density
Time Frame
2 weeks after PKP
Title
Endothelial cell density
Time Frame
1 month after PKP
Title
Endothelial cell density
Time Frame
3 months after PKP
Title
Endothelial cell density
Time Frame
6 months after PKP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Eye Hospital, Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qian gui, MD
Phone
8613600643736
Email
389997168@qq.com
First Name & Middle Initial & Last Name & Degree
qinxiang zheng, PhD
Phone
8613738379810
First Name & Middle Initial & Last Name & Degree
Jinyang Li, MD,PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
23860425
Citation
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.
Results Reference
background
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Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
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