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Status unknownNCT02826174Updated Jul 7, 2016

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

An interventional study of closed PKP under topical anesthesia and open-sky PKP under retrobulbar anesthesia in Corneal Opacity, Keratitis, Herpetic and Corneal Ulcer, sponsored by Wenzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-07-07.

Sponsored by Wenzhou Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Corneal Opacity
  • Keratitis, Herpetic
  • Corneal Ulcer
  • Corneal Dystrophies, Hereditary
03

In context

Corneal Opacity

37 studies on the registry are indexed under Corneal Opacity; 5 are open to participants now.

This study's planned enrollment of 60 is above the median of 27 across 20 interventional studies indexed under Corneal Opacity.

Browse Corneal Opacity studies →

Lead sponsor

Wenzhou Medical University is the lead sponsor of 94 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • active bacterial keratitis, for which ulceration progressed despite maximum antibacterial medication;
  • 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    closed PKP under topical anesthesia

    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

  • Active comparator
    open-sky PKP under retrobulbar anesthesia

    an open-sky corneal transplantation under retrobulbar anesthesia

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

  • Other
    Anti-Rejection Agents

    Anti-Rejection Agents for both groups

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

  • Other
    Anti-Inflammatory Agents

    Anti-Inflammatory Agents for both groups

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

Interventions

  • Procedureclosed PKP under topical anesthesia

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

  • Procedureopen-sky PKP under retrobulbar anesthesia

    an open-sky corneal transplantation under retrobulbar anesthesia

  • DrugAnti-Rejection Agents

    Anti-Rejection Agents for both groups

  • DrugAnti-Inflammatory Agents

    Anti-Inflammatory Agents for both groups

06

What researchers measure

Primary outcomes

  1. best corrected visual acuity

    Time frame: preoperative

  2. best corrected visual acuity

    Time frame: 1 week after PKP

  3. best corrected visual acuity

    Time frame: 2 weeks after PKP

  4. best corrected visual acuity

    Time frame: 1 month after PKP

  5. best corrected visual acuity

    Time frame: 3 months after PKP

  6. best corrected visual acuity

    Time frame: 6 months after PKP

Secondary outcomes

  1. Endothelial cell density

    Time frame: 1 week after PKP

  2. Endothelial cell density

    Time frame: 2 weeks after PKP

  3. Endothelial cell density

    Time frame: 1 month after PKP

  4. Endothelial cell density

    Time frame: 3 months after PKP

  5. Endothelial cell density

    Time frame: 6 months after PKP

07

Study locations

1 of 1 sites recruiting
  • Eye Hospital, Wenzhou Medical College
    Wenzhou, Zhejiang 325027, China
    Recruiting
    • qian gui, MD · Contact389997168@qq.com · 8613600643736
    • qinxiang zheng, PhD · Contact8613738379810
    • Jinyang Li, MD,PhD · Principal investigator
08

References and documents

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. PubMed 23860425 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2015, a primary completion of Dec 2016 and a completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2016
First posted
Jul 7, 2016
Start
Dec 2015
Primary completionEst.
Dec 2016
CompletionEst.
Dec 2016
Last update
Jul 7, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02826174
Lead sponsor
Wenzhou Medical University
Responsible party
Jinyang Li (PhD, Wenzhou Medical University) — Principal investigator
First posted
Jul 7, 2016
Start date
Dec 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jul 7, 2016
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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