Corneal Epithelial Autograft for Limbal Dermoid

Corneal Dermoid Clinical Trial

Official title:

A Non-randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Limbal Dermoid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03217461
• Other study ID #: 2017KYPJ056
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2019
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D.Ph.D.
• Phone: +8613922286455
• Email: yingfeng.zheng[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Dermoid
• Dermoid Cyst

Intervention

Procedure:
• CorneaL epithelial autograft
After removal of the recipient's diseased dermoid, a size-match donor epithelial tissue will be obtained from the healthy area of the same eye (corneal epithelial autograft) using femtosecond laser technology, with the goal of closure of bare stromal area by sutured corneal epithelial tissue to ensure the integrity of ocular surface. This closure may also create a microenvironment that stimulates stromal cells' regenerative capacity and regulates their epithelial-mesenchymal transition process.

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 by sutured femtosecond laser-assisted limbal autograft.

Device:
• Femtosecond laser
A commercial femtosecond laser to create a particular shaped graft for transplantation

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chunxiao Wang

Country where clinical trial is conducted

China, 

Outcome

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