Corneal TransplantationNCT04490902
Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty
A study testing Limbal transplantation combined with central penetrating keratoplasty in people with Corneal Transplantation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- Limbal transplantation combined with central penetrating keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2020to Jul 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Central corneal opacity involving full layer
- Corneal neovascularization in two or more quadrants
- Patients must be willing and able to return for scheduled follow-up examinations for 12 months after surgery
- Ages：18 -70 Years
Who cannot join
- Central corneal opacity not involving the endothelial layer
- Less than two quadrants of corneal neovascularization
- History of Stevens-Johnson syndrome or Sjogren's syndrome
- Severe eyelid and conjunctival scar
- Loss of vision in contralateral eye
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Ling Jin, 86-20-87334687, lingjin41@yahoo.com
Ting Huang, MD, PHD
About this study
Official title: Suppression of Graft Rejection Using Mixed Component Cornea in the High-risk Keratoplasty，A Randomized Controlled Trial.
Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk keratoplasty.
This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors.
Read the detailed description
Ocular trauma or infection lead to corneal limbal stem cell deficiency and central corneal opacification which could only be treated by central penetrating keratoplasty and limbal transplantation, but the rejection rate is very high. In clinical, we found that limbal transplantation combined with central penetrating keratoplasty from different donors can keep the graft transparent for a long time, this result also be found in organ transplantation, multiple donor organ transplantation could reduce rejection risk in liver and kidney transplantation. Therefore, it is speculated that there are different MHC antigens from different donors, which cause different reactions after transplantation. Because there are a large number of Langerhans cells， abundant blood vessels and lymphatic in the limbal, so the rejection occurs early and severely. Continuous and intense limbal rejection leads to the depletion of recipient T cells, lead to the immune tolerance of another donor's central corneal tissue. In this project, central penetrating keratoplasty and limbal transplantation from different donors will be carried out and the graft survival of high-risk corneal transplantation will be observed in clinical, to find a new method for high-risk corneal transplant patients.
- Conditions
- Corneal Transplantation
- Being tested
- Limbal transplantation combined with central penetrating keratoplasty
- Keywords
- High-risk corneal transplantation, Penetrating keratoplasty, Limbal transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limbal transplantation combined with central penetrating keratoplastyProcedure or surgery
Limbal transplantation combined with central penetrating keratoplasty with single donor cornea
Limbal transplantation combined with central penetrating keratoplastyProcedure or surgery
Limbal transplantation combined with central penetrating keratoplasty with mixed component cornea
| Study group | Role | What they receive |
|---|---|---|
| Single graft corneal transplantation | Active comparator | Limbal transplantation combined with central penetrating keratoplasty from single donors. Receives: Procedure: Limbal transplantation combined with central penetrating keratoplasty |
| Dual graft corneal transplantation | Experimental | Limbal transplantation combined with central penetrating keratoplasty from different donors. Receives: Procedure: Limbal transplantation combined with central penetrating keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of corneal graft rejection at 12 months
The rejection index of corneal transplantation will be observed by slit lamp after surgery
Measured: 12 months
Secondary outcomes (5)
The changes of best corrected visual acuity
Best corrected visual acuity in different point will be compared with preoperative
Measured: Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months
The changes of corneal thickness depth
Corneal thickness depth will be measured by anterior segmental OCT and compared with preoperative
Measured: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Reconstruction of corneal limbal
Confocal microscopy will be used to define whether the structure of corneal limbal has reconstructed
Measured: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Endothelial Cell Density
Endothelial Cell Density will be measured by specular microscope to evaluate the loss of endothelial cells
Measured: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
The rate of presence of goblet cells containing conjunctival epithelium on the corneal surface by impression cytology
Detects whether conjunctival epithelial and goblet cells have invaded the corneal surface by impression cytology, to observe the reconstruction of limbal function
Measured: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start18 Aug 2020
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal TransplantationStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490902
- Sponsor's protocol ID
- 2020KYPJ111
- Status last verified
- Feb 2022
- First submitted
- 22 Jul 2020
- Last updated
- 24 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suppression of Graft Rejection Using Mixed Component Cornea in the High-risk Keratoplasty，A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04490902
- Acronym / sponsor ID
- 2020KYPJ111
- Conditions
- Corneal Transplantation
- Keywords
- High-risk corneal transplantation, Penetrating keratoplasty, Limbal transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 29 Jul 2020 (actual)
- 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.
Because of the immunologically privileged nature of the cornea, the graft rejection rate is less than 10% for low-risk keratoplasty. But when the cornea performed 2 or more quadrants of corneal neovascularization after ocular trauma or infection, the graft rejection rate is more than 65%, it is called high-risk keratoplasty.
This study will observe the graft survival of high-risk corneal transplantation using mixed component cornea from different donors.
Detailed description
Ocular trauma or infection lead to corneal limbal stem cell deficiency and central corneal opacification which could only be treated by central penetrating keratoplasty and limbal transplantation, but the rejection rate is very high. In clinical, we found that limbal transplantation combined with central penetrating keratoplasty from different donors can keep the graft transparent for a long time, this result also be found in organ transplantation, multiple donor organ transplantation could reduce rejection risk in liver and kidney transplantation. Therefore, it is speculated that there are different MHC antigens from different donors, which cause different reactions after transplantation. Because there are a large number of Langerhans cells， abundant blood vessels and lymphatic in the limbal, so the rejection occurs early and severely. Continuous and intense limbal rejection leads to the depletion of recipient T cells, lead to the immune tolerance of another donor's central corneal tissue. In this project, central penetrating keratoplasty and limbal transplantation from different donors will be carried out and the graft survival of high-risk corneal transplantation will be observed in clinical, to find a new method for high-risk corneal transplant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single graft corneal transplantation | Active comparator | Procedure: Limbal transplantation combined with central penetrating keratoplastyLimbal transplantation combined with central penetrating keratoplasty from single donors. |
| Dual graft corneal transplantation | Experimental | Procedure: Limbal transplantation combined with central penetrating keratoplastyLimbal transplantation combined with central penetrating keratoplasty from different donors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Central corneal opacity involving full layer
- Corneal neovascularization in two or more quadrants
- Patients must be willing and able to return for scheduled follow-up examinations for 12 months after surgery
- Ages：18 -70 Years
Key exclusion criteria (6 listed)
- Central corneal opacity not involving the endothelial layer
- Less than two quadrants of corneal neovascularization
- History of Stevens-Johnson syndrome or Sjogren's syndrome
- Severe eyelid and conjunctival scar
- Loss of vision in contralateral eye
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 |
|---|---|---|
| Limbal transplantation combined with central penetrating keratoplastyLimbal transplantation combined with central penetrating keratoplasty with single donor cornea | Procedure or surgery | Single graft corneal transplantation |
| Limbal transplantation combined with central penetrating keratoplastyLimbal transplantation combined with central penetrating keratoplasty with mixed component cornea | Procedure or surgery | Dual graft corneal transplantation |
Primary outcome
The rate of corneal graft rejection at 12 months
Time frame: 12 months
The rejection index of corneal transplantation will be observed by slit lamp after surgery
5 secondary outcomes
The changes of best corrected visual acuity
Time frame: Before surgery, 1 week, 1 month, 3 months, 6 months, 12 months
The changes of corneal thickness depth
Time frame: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Reconstruction of corneal limbal
Time frame: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Endothelial Cell Density
Time frame: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
The rate of presence of goblet cells containing conjunctival epithelium on the corneal surface by impression cytology
Time frame: baseline (Before surgery), 1 week, 1 month, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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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 Limbal transplantation combined with central penetrating keratoplasty in people with Corneal Transplantation, run by Zhongshan Ophthalmic Center, Sun Yat-sen 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 6 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 24 Feb 2022. 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?
Contact Ting Huang, MD, PHD (86-13552338050, qingerdong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of corneal graft rejection at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2022.