Glycerin Cryopreserved Acellular Corneal TissueNCT01021046
Deep Anterior Lamellar Keratoplasty (DALK) Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
A study testing DALK using GCCT and DALK using FCT in people with Glycerin Cryopreserved Acellular Corneal Tissue and Deep Anterior Lamellar Keratoplasty, run by Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glycerin Cryopreserved Acellular Corneal Tissue, Deep Anterior Lamellar Keratoplasty, High Risk Keratoplasty
- What is being tested?
- DALK using GCCT and DALK using FCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Dec 2006to Jul 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe bacterial keratitis
- Herpes simplex keratitis
- severe fungal keratitis
- partial limbal deficiency after chemical burn
Who cannot join
- posterior stroma involved in severe bacterial and fungal keratitis
- dry eye
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
- patients with severe systemic diseases not good for ocular surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deep Anterior Lamellar Keratoplasty Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients.
- Conditions
- Glycerin Cryopreserved Acellular Corneal Tissue, Deep Anterior Lamellar Keratoplasty, High Risk Keratoplasty
- Being tested
- DALK using GCCT, DALK using FCT
- Keywords
- deep anterior lamellar keratoplasty, rejection, high risk patients, acellular corneal tissue
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DALK using GCCTProcedure or surgery
Also called acellular tissue
Deep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue
DALK using FCTProcedure or surgery
Deep anterior lamellar keratoplasty (DALK) using fresh corneal tissue
| Study group | Role | What they receive |
|---|---|---|
| GCCT,corneal allograft survival ,DALK | Experimental | experimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue Receives: Procedure: DALK using GCCT |
| FCT,corneal allograft survival ,DALK | Experimental | control group: deep anterior lamellar keratoplasty using fresh corneal tissue Receives: Procedure: DALK using FCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
rejection
Secondary outcomes (1)
laser scanning in vivo confocal microscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startDec 2006
- Primary completionJul 2010
- Study completionJul 2010
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 Glycerin Cryopreserved Acellular Corneal TissueStudies 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
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Wei Chen, MD,PhD, Principal investigator, Eye Hospital, Wenzhou Medical College, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021046
- Sponsor's protocol ID
- 10001
- Status last verified
- Nov 2006
- First submitted
- 25 Nov 2009
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li J, Yu L, Deng Z, Wang L, Sun L, Ma H, Chen W. Deep anterior lamellar keratoplasty using acellular corneal tissue for prevention of allograft rejection in high-risk corneas. Am J Ophthalmol. 2011 Nov;152(5):762-70.e3. doi: 10.1016/j.ajo.2011.05.002. Epub 2011 Jul 30.
PubMed 21803324
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Anterior Lamellar Keratoplasty Using Acellular Corneal Tissue Promotes Corneal Allograft Survival in High Risk Patients
- ClinicalTrials.gov ID
- NCT01021046
- Acronym / sponsor ID
- 10001
- Conditions
- Glycerin Cryopreserved Acellular Corneal Tissue, Deep Anterior Lamellar Keratoplasty, High Risk Keratoplasty
- Keywords
- deep anterior lamellar keratoplasty, rejection, high risk patients, acellular corneal tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Nov 2009 (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.
The purpose of this study is to study whether deep anterior lamellar keratoplasty (DALK) using acellular tissue will promote corneal graft survival in high risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCCT,corneal allograft survival ,DALK | Experimental | Procedure: DALK using GCCTexperimental group: deep anterior lamellar keratoplasty using glycerin-cryopreserved corneal tissue |
| FCT,corneal allograft survival ,DALK | Experimental | Procedure: DALK using FCTcontrol group: deep anterior lamellar keratoplasty using fresh corneal tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- severe bacterial keratitis
- Herpes simplex keratitis
- severe fungal keratitis
- partial limbal deficiency after chemical burn
Key exclusion criteria (6 listed)
- posterior stroma involved in severe bacterial and fungal keratitis
- dry eye
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
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 |
|---|---|---|
| DALK using GCCTAlso: acellular tissueDeep anterior lamellar keratoplasty (DALK) using glycerin-cryopreserved corneal tissue | Procedure or surgery | GCCT,corneal allograft survival ,DALK |
| DALK using FCTDeep anterior lamellar keratoplasty (DALK) using fresh corneal tissue | Procedure or surgery | FCT,corneal allograft survival ,DALK |
Primary outcome
rejection
1 secondary outcome
laser scanning in vivo confocal microscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Derived from this study: PubMed 21803324Li J, Yu L, Deng Z, Wang L, Sun L, Ma H, Chen W. Deep anterior lamellar keratoplasty using acellular corneal tissue for prevention of allograft rejection in high-risk corneas. Am J Ophthalmol. 2011 Nov;152(5):762-70.e3. doi: 10.1016/j.ajo.2011.05.002. Epub 2011 Jul 30.
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.
Wei Chen, MD,PhD principal investigator
Eye Hospital, Wenzhou Medical College, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DALK using GCCT and DALK using FCT in people with Glycerin Cryopreserved Acellular Corneal Tissue and Deep Anterior Lamellar Keratoplasty, 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 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: finished, as of the sponsor's last update on 3 Aug 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rejection. 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 NCT01021046, 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 3 Aug 2010.