Clinical trial NCT02826174: Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Opacity
Keratitis, Herpetic
Corneal Ulcer
Corneal Dystrophies, Hereditary
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: best corrected visual acuity
timeFrame: preoperative
measure: best corrected visual acuity
timeFrame: 1 week after PKP
measure: best corrected visual acuity
timeFrame: 2 weeks after PKP
measure: best corrected visual acuity
timeFrame: 1 month after PKP
measure: best corrected visual acuity
timeFrame: 3 months after PKP
measure: best corrected visual acuity
timeFrame: 6 months after PKP
Secondary outcomes:
measure: Endothelial cell density
timeFrame: 1 week after PKP
measure: Endothelial cell density
timeFrame: 2 weeks after PKP
measure: Endothelial cell density
timeFrame: 1 month after PKP
measure: Endothelial cell density
timeFrame: 3 months after PKP
measure: Endothelial cell density
timeFrame: 6 months after PKP
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
References:
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.