Corneal Epithelial Autograft for Limbal Dermoid

Not Applicable

• Conditions: Corneal Dermoid
• Interventions: Procedure: CorneaL epithelial autograft; Procedure: Limbal autograft; Device: Femtosecond laser

• Registration Number: NCT03217461
• Lead Sponsor: Chunxiao Wang

Brief Summary

The purpose of the study is to explore whether femtosecond laser-assisted corneal epithelial autograft is more effective than femtosecond laser-assisted limbal autograft for ocular surface reconstruction after excision of limbal dermoid.

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: 2017-07-18
• Status Verified: 2019-04
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age between 1 to 30 years old;
2. Patients with limbal dermoid, scheduled for elective surgical excision;
3. Superficial lesion ranging from 5 to 9mm, without encroaching the deep stroma layer, as indicated by anterior segment optical coherence tomography images;
4. Informed consent signed by a parent or legal guardian, or having the capability of understanding and signing the informed consent;
5. Being able to comply with study assessments for the full duration of the study.

Exclusion Criteria

1. Keratoconus;
2. Ocular and facial active inflammation such as keratitis, trachoma, dacryocystitis, blepharitis, meibomian gland dysfunction, Sjogren's syndrome, cicatricial pemphigoid etc;
3. High myopia with a spherical equivalent of -15.0 D or less;
4. Corneal or ocular surface infection within 30 days prior to study entry;
5. Ocular surface malignancy;
6. Uncontrolled diabetes with most recent Hemoglobin A1c greater than 8.5%;
7. Renal failure with creatinine clearance< 25ml/min;
8. Alanine aminotransferase > 40IU/L, or aspartate aminotransferase > 40IU/L;
9. Platelet levels < 150,000 or > 450,000 per microliter;
10. Hemoglobin < 12.0 g/dL (male) or < 11.0 g/dL (female);
11. 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;
12. Pregnancy (positive test) or lactation;
13. Participation in another simultaneous medical investigation or clinical trial;
14. Severe cicatricial eye disease;
15. Ocular comorbidities that affect the prognosis of transplantation, such as advanced glaucoma or retinal diseases;
16. Severe dry eye disease as determined by Schirmer's test < 2mm at least in one eye;
17. Any medical or social condition that in the judgement of the investigator would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent;
18. Signs of current infection, including fever and treatment with antibiotics;
19. Active immunological diseases;
20. History of allo-limbal transplantation, penetrating keratoplasty or anti-glaucoma filtering surgeries.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corneal epithelial autograft	CorneaL epithelial autograft	Corneal dermoid tumor resection combined with femtosecond laser assisted corneal epithelial autograft
Corneal epithelial autograft	Femtosecond laser	Corneal dermoid tumor resection combined with femtosecond laser assisted corneal epithelial autograft
Limbal autograft	Femtosecond laser	Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft
Limbal autograft	Limbal autograft	Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft

Primary Outcome Measures

Name	Time	Method
Restoration of corneal surface	1 year	Restoration of a completely epithelized, stable, and avascular corneal surface.

Secondary Outcome Measures

Name	Time	Method
Cosmetic improvement	1 year	A grading system from 0 to 4 with slit-lamp photographs will be used to determine cosmetic result of each graft.
Corneal Thickness	1 year	To measure corneal thickness using anterior segment optical coherence tomography.
Best corrected visual acuity	1 year	To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.
Density of stromal nerve and stromal keratocytes	1 year	To assess the stromal nerve and stromal keratocytes using in vivo confocal microscopy.
Corneal haze	1 year	To assess corneal haze using in vivo confocal microscopy.
Corneal power, astigmatism and aberration	1 year	To measure the changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.

Trial Locations

Locations (1)

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