Corneal Autograft for Limbal Dermoid

Chunxiao Wang

Status: Completed

Conditions: Corneal Dermoid

Treatments: Device: Femtosecond laser; Procedure: Limbal autograft

Study type: Interventional

Funder types: Other

Identifiers

NCT03217461

2020KYPJ206

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 5 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Limbal autograft

Experimental group

Description:

Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft

Treatment:

Procedure: Limbal autograft

Device: Femtosecond laser