Corneal Autograft for Limbal Dermoid

Not Applicable

Completed

• Conditions: Corneal Dermoid

• Registration Number: NCT03217461
• Lead Sponsor: Chunxiao Wang

Brief Summary

To investigate the clinical efficacy of femtosecond laser-assisted autologous lamellar keratoplasty in treating corneal dermoids.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-12
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2022-05-10
• Primary Completion: 2024-11-29
• Study Completion: 2024-11-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Corneal Thickness	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	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

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively	To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.
Corneal power, astigmatism and aberration	Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively	To measure the changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.
Cosmetic improvement	Preoperatively, 1 week, 1 month, 3 months, 6 months, 9 months, 12 months and 18 months postoperatively	A grading system from 0 to 4 with slit-lamp photographs will be used to determine cosmetic result of each graft.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity; 🇨🇳 Guangzhou, Guangdong, China