Corneal Perforation, Corneal Stromal Lenticule,Sandwich TechniqueSTMIKNCT06233409
A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation
An observational study of Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness. The main question[s] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2020to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients premedicated for keratoplasty surgery
Who may be able to join
- Patients with corneal perforation who are willing to undergo treatment with this new technique;
- The size of cornea perforation was ≦ 3mm
Who cannot join
- The size of cornea perforation was \>3mm
- Patients with corneal perforation who were unwilling to be treated with this new technique.
- Patients who could not be followed up regularly.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
yan wang, director, +862227313336, wangyan7143@vip.sina.com
About this study
The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.
The main question[s] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.
Read more
2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.
Participants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP.
- Keywords
- Corneal perforation, Corneal stromal lenticule,Sandwich technique
- Medical subject headings
- Corneal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lenticules group | Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography | |
| Penetrating keratoplasty group | Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Novel Sandwich Technique for Corneal Perforation
By sandwiching the corneal lenticules interlamellar implantation, STMIK as an alternative novel treatment and effective procedure that provides an option to restore the corneal integrity and improve vision in patients with corneal perforations.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start23 Oct 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Perforation, Corneal Stromal Lenticule,Sandwich TechniqueStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233409
- Sponsor's protocol ID
- zhangyi2023
- Acronym
- STMIK
- Status last verified
- Jan 2024
- First submitted
- 23 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Sandwich Technique of Minimally Invasive Keratoplasty for Corneal Perforation
- ClinicalTrials.gov ID
- NCT06233409
- Acronym / sponsor ID
- STMIK / zhangyi2023
- Keywords
- Corneal perforation, Corneal stromal lenticule,Sandwich technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 23 Oct 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Jan 2024 (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.
The goal of this type of study to describe a new sandwich technique of minimally invasive keratoplasty (STMIK) by using SMILE-extracted lenticules for treatment corneal perforation and effectiveness.
The main question[s] it aims to answer are: 1.Corneal perforations require urgent attendances for prompt treatments. How can we restore the integrity of the eyeball as soon as possible, reduce complications, and restore vision in the case of lack of corneal material according to the conditions that may be obtained.
2.In China, nearly 1 million lenticules are obtained through all-femtosecond surgery every year. How to reuse and turn waste into precious materials for clinical application is an important study.
Participants will understand and signed the informed consent to take this new method for the treatment of their corneal perforations disease, which will obtain good results, but there may be a certain risk of complications.The main tasks participants will be asked to cooperate as required.The clinical eye check includes the test of includes visual acuity, slit lamp, anterior segment phase, anterior segment OCT and IOP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lenticules group | – | –Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography |
| Penetrating keratoplasty group | – | –Morphology of cornea and intra-ocular pressure were obtained by optical coherence tomography, Non-contact tonometer, Slit-lamp photography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients premedicated for keratoplasty surgery
Key inclusion criteria (2 listed)
- Patients with corneal perforation who are willing to undergo treatment with this new technique;
- The size of cornea perforation was ≦ 3mm
Key exclusion criteria (3 listed)
- The size of cornea perforation was \>3mm
- Patients with corneal perforation who were unwilling to be treated with this new technique.
- Patients who could not be followed up regularly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A Novel Sandwich Technique for Corneal Perforation
Time frame: one year
By sandwiching the corneal lenticules interlamellar implantation, STMIK as an alternative novel treatment and effective procedure that provides an option to restore the corneal integrity and improve vision in patients with corneal perforations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Corneal Perforation, Corneal Stromal Lenticule,Sandwich Technique, run by Tianjin Eye Hospital 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 2 inclusion and 3 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 31 Jan 2024. 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 Luxia Chen，PHD,MD, Doctorate (Telephone: 022-27313336 ext. +8618202287817, Chen2006317@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A Novel Sandwich Technique for Corneal Perforation (time frame: one year). 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 31 Jan 2024.