Corneal Autograft for Limbal Dermoid

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.

Study Overview

• Status: Completed
• Conditions: Corneal Dermoid
• Intervention / Treatment: Device: Femtosecond laser; Procedure: Limbal autograft

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510070
      • Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 30 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 5 to 35 years old,
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:

1. Keratoconus,
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Limbal autograft; Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft	Device: Femtosecond laser; A commercial femtosecond laser to create a particular shaped graft for transplantation; Procedure: Limbal autograft; Simple dermoid excision will be performed, followed by closure of the bare sclera and cornea by sutured femtosecond laser-assisted limbal autograft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Thickness	To measure corneal thickness using anterior segment optical coherence tomography.	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	Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.	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.	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.	Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of corneal surface	Restoration of a completely epithelized, stable, and avascular corneal surface.	1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively

Collaborators and Investigators

• Sponsor: Chunxiao Wang
• Investigators: Principal Investigator: Yizhi Liu, M.D.Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University; Principal Investigator: Ting Huang, M.D.Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: July 12, 2017
• First Submitted That Met QC Criteria: July 12, 2017
• First Posted (Actual): July 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Germ Cell and Embryonal; Cysts; Teratoma; Dermoid Cyst
• Other Study ID Numbers: 2020KYPJ206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No