Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2022-05-10
2024-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Limbal autograft
Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft
Limbal autograft
Simple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft.
Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation
Interventions
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Limbal autograft
Simple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft.
Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation
Eligibility Criteria
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Inclusion Criteria
2. Patients with limbal dermoid, scheduled for elective surgical excision,
3. The distance of less than 5 mm of lesion encroachment into the cornea,
4. 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.
Exclusion Criteria
2. High myopia with a spherical equivalent of -15.0 D or less,
3. Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc,
4. Corneal or ocular surface infection within 30 days prior to study entry,
5. Severe cicatricial eye disease,
6. Ocular surface malignancy,
7. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases,
8. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries,
9. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%,
10. Renal failure with creatinine clearance\< 25ml/min,
11. Alanine aminotransferase \> 40IU/L, or aspartate aminotransferase \> 40IU/L,
12. Platelet levels \< 150,000 or \> 450,000 per microlite,
13. Hemoglobin \< 12.0 g/dL (male) or \< 11.0 g/dL (female),
14. 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,
15. Pregnancy (positive test) or lactation,
16. Active immunological diseases,
17. Signs of current infection, including fever and treatment with antibiotics,
18. Participation in another simultaneous medical investigation or clinical trial.
5 Years
35 Years
ALL
No
Sponsors
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Chunxiao Wang
OTHER
Responsible Party
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Chunxiao Wang
Clinical investigator
Principal Investigators
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Yizhi Liu, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Ting Huang, M.D.Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Ophthalmic Center, Sun Yat-sen University
Locations
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Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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2020KYPJ206
Identifier Type: -
Identifier Source: org_study_id
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