Corneal DermoidNCT03217461
Corneal Autograft for Limbal Dermoid
A study testing Limbal autograft and Femtosecond laser in people with Corneal Dermoid, run by Chunxiao Wang at 1 site in China.
Trial summary
To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Corneal Dermoid
- What is being tested?
- Limbal autograft and Femtosecond laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to 29 Nov 2024
- 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 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 5 to 35 years old,
- Patients with limbal dermoid, scheduled for elective surgical excision,
- The distance of less than 5 mm of lesion encroachment into the cornea,
- The participant or their legal guardian has voluntarily chosen to participate in this study, has signed the informed consent form, and has demonstrated a high level of adherence to the study protocols and cooperation throughout the follow-up process.
Who cannot join
- Keratoconus,
- High myopia with a spherical equivalent of -15.0 D or less,
- Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc,
- Corneal or ocular surface infection within 30 days prior to study entry,
- Severe cicatricial eye disease,
- Ocular surface malignancy,
Show all 18Show fewer
- Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases,
- History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries,
- Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%,
- Renal failure with creatinine clearance< 25ml/min,
- Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L,
- Platelet levels < 150,000 or > 450,000 per microlite,
- Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female),
- Prothrombin time > 16s and activated partial thrombin time > 35s in patients not accepting anticoagulant therapy, An international normalized ratio greater than 3 in patients accepting anticoagulant therapy,
- Pregnancy (positive test) or lactation,
- Active immunological diseases,
- Signs of current infection, including fever and treatment with antibiotics,
- Participation in another simultaneous medical investigation or clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, 510070
About this study
Official title: A Non-randomized Controlled Clinical Trial of Corneal Autograft for Limbal Dermoid
To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids.
- Conditions
- Corneal Dermoid
- Being tested
- Limbal autograft, Femtosecond laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limbal autograftProcedure or surgery
Simple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft.
Femtosecond laserDevice
A commercial femtosecond laser to create a particular shaped graft for transplantation
| Study group | Role | What they receive |
|---|---|---|
| Limbal autograft | Experimental | Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft Receives: Procedure: Limbal autograft; Device: Femtosecond laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Thickness
To measure corneal thickness using anterior segment optical coherence tomography.
Measured: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Corneal Transparency
The transparency and appearance of the cornea will be observed using slit-lamp microscopy
Measured: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Secondary outcomes (3)
Best corrected visual acuity
To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.
Measured: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Corneal power, astigmatism and aberration
To measure the changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
Measured: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Cosmetic improvement
A grading system from 0 to 4 with slit-lamp photographs will be used to determine cosmetic result of each graft.
Measured: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start10 May 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DermoidStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chunxiao Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunxiao Wang, Sun Yat-sen University
- Investigators
- Yizhi Liu, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen UniversityTing Huang, M.D.Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217461
- Sponsor's protocol ID
- 2020KYPJ206
- Status last verified
- Apr 2025
- First submitted
- 12 Jul 2017
- Last updated
- 26 Jun 2025
- 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 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Controlled Clinical Trial of Corneal Autograft for Limbal Dermoid
- ClinicalTrials.gov ID
- NCT03217461
- Acronym / sponsor ID
- 2020KYPJ206
- Conditions
- Corneal Dermoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Chunxiao WangUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 14 Jul 2017 (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.
To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Limbal autograft | Experimental | Procedure: Limbal autograft, Device: Femtosecond laserCorneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 5 to 35 years old,
- Patients with limbal dermoid, scheduled for elective surgical excision,
- The distance of less than 5 mm of lesion encroachment into the cornea,
- The participant or their legal guardian has voluntarily chosen to participate in this study, has signed the informed consent form, and has demonstrated a high level of adherence to the study protocols and cooperation throughout the follow-up process.
Key exclusion criteria (18 listed)
- Keratoconus,
- High myopia with a spherical equivalent of -15.0 D or less,
- Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc,
- Corneal or ocular surface infection within 30 days prior to study entry,
- Severe cicatricial eye disease,
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 autograftSimple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft. | Procedure or surgery | Limbal autograft |
| Femtosecond laserA commercial femtosecond laser to create a particular shaped graft for transplantation | Device | Limbal autograft |
Primary outcome
Corneal Thickness
Time frame: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
To measure corneal thickness using anterior segment optical coherence tomography.
Corneal Transparency
Time frame: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
The transparency and appearance of the cornea will be observed using slit-lamp microscopy
3 secondary outcomes
Best corrected visual acuity
Time frame: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Corneal power, astigmatism and aberration
Time frame: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
Cosmetic improvement
Time frame: Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively
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 26 Jun 2025.
- Individual participant dataSharing planned: No
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.
Yizhi Liu, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Ting Huang, M.D.Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 autograft and Femtosecond laser in people with Corneal Dermoid, run by Chunxiao Wang 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 18 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 26 Jun 2025. 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?
Corneal Thickness (time frame: 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively). The study lists 2 primary outcomes in all. 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 26 Jun 2025.