Corneal OpacityNCT02826174
Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
A study testing closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia and Anti-Rejection Agents in people with Corneal Opacity and Keratitis, Herpetic, run by Wenzhou Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Corneal Opacity, Keratitis, Herpetic, Corneal Ulcer
- What is being tested?
- closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia and Anti-Rejection Agents
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, 325027
qian gui, MD, 8613600643736, 389997168@qq.com
qinxiang zheng, PhD, 8613738379810
About this study
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.
- Being tested
- closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia, Anti-Rejection Agents, Anti-Inflammatory Agents
- Medical subject headings
- Corneal Opacity, Keratitis, Herpetic, Corneal Ulcer, Corneal Dystrophies, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed PKP under topical anesthesiaProcedure or surgery
a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
open-sky PKP under retrobulbar anesthesiaProcedure or surgery
an open-sky corneal transplantation under retrobulbar anesthesia
Anti-Rejection AgentsDrug
Anti-Rejection Agents for both groups
Anti-Inflammatory AgentsDrug
Anti-Inflammatory Agents for both groups
| Study group | Role | What they receive |
|---|---|---|
| closed PKP under topical anesthesia | Experimental | a closed corneal transplantation under topical anesthesia with the anterior chamber maintained Receives: 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 Receives: 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 Receives: Procedure: closed PKP under topical anesthesia; Procedure: open-sky PKP under retrobulbar anesthesia |
| Anti-Inflammatory Agents | Other | Anti-Inflammatory Agents for both groups Receives: Procedure: closed PKP under topical anesthesia; Procedure: open-sky PKP under retrobulbar anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
Measured: preoperative
best corrected visual acuity
Measured: 1 week after PKP
best corrected visual acuity
Measured: 2 weeks after PKP
best corrected visual acuity
Measured: 1 month after PKP
best corrected visual acuity
Measured: 3 months after PKP
best corrected visual acuity
Measured: 6 months after PKP
Secondary outcomes (5)
Endothelial cell density
Measured: 1 week after PKP
Endothelial cell density
Measured: 2 weeks after PKP
Endothelial cell density
Measured: 1 month after PKP
Endothelial cell density
Measured: 3 months after PKP
Endothelial cell density
Measured: 6 months after PKP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal OpacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinyang Li, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826174
- Sponsor's protocol ID
- Closed PKP
- Status last verified
- Jul 2016
- First submitted
- 21 Jun 2016
- Last updated
- 7 Jul 2016
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia for Closed PKP vs Retrobulbar Anesthesia for Open-sky PKP
- ClinicalTrials.gov ID
- NCT02826174
- Acronym / sponsor ID
- Closed PKP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| closed PKP under topical anesthesia | Experimental | Procedure: closed PKP under topical anesthesia, Drug: Anti-Rejection Agents, Drug: Anti-Inflammatory Agentsa closed corneal transplantation under topical anesthesia with the anterior chamber maintained |
| open-sky PKP under retrobulbar anesthesia | Active comparator | Procedure: open-sky PKP under retrobulbar anesthesia, Drug: Anti-Rejection Agents, Drug: Anti-Inflammatory Agentsan open-sky corneal transplantation under retrobulbar anesthesia |
| Anti-Rejection Agents | Other | Procedure: closed PKP under topical anesthesia, Procedure: open-sky PKP under retrobulbar anesthesiaAnti-Rejection Agents for both groups |
| Anti-Inflammatory Agents | Other | Procedure: closed PKP under topical anesthesia, Procedure: open-sky PKP under retrobulbar anesthesiaAnti-Inflammatory Agents for both groups |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed PKP under topical anesthesiaa closed corneal transplantation under topical anesthesia with the anterior chamber maintained | Procedure or surgery | Anti-Inflammatory Agents, Anti-Rejection Agents, closed PKP under topical anesthesia |
| open-sky PKP under retrobulbar anesthesiaan open-sky corneal transplantation under retrobulbar anesthesia | Procedure or surgery | Anti-Inflammatory Agents, Anti-Rejection Agents, open-sky PKP under retrobulbar anesthesia |
| Anti-Rejection AgentsAnti-Rejection Agents for both groups | Drug | closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia |
| Anti-Inflammatory AgentsAnti-Inflammatory Agents for both groups | Drug | closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia |
Primary outcome
best corrected visual acuity
Time frame: preoperative
best corrected visual acuity
Time frame: 1 week after PKP
best corrected visual acuity
Time frame: 2 weeks after PKP
best corrected visual acuity
Time frame: 1 month after PKP
best corrected visual acuity
Time frame: 3 months after PKP
best corrected visual acuity
Time frame: 6 months after PKP
5 secondary outcomes
Endothelial cell density
Time frame: 1 week after PKP
Endothelial cell density
Time frame: 2 weeks after PKP
Endothelial cell density
Time frame: 1 month after PKP
Endothelial cell density
Time frame: 3 months after PKP
Endothelial cell density
Time frame: 6 months after PKP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Background: PubMed 23860425Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed PKP under topical anesthesia, open-sky PKP under retrobulbar anesthesia and Anti-Rejection Agents in people with Corneal Opacity and Keratitis, Herpetic, run by Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best corrected visual acuity (time frame: preoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02826174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2016.