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Corneal Epithelial Autograft for Limbal Dermoid

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ClinicalTrials.gov Identifier: NCT03217461
Recruitment Status : Recruiting
First Posted : July 14, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Chunxiao Wang, Sun Yat-sen University

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.

Condition or disease Intervention/treatment Phase
Corneal Dermoid Procedure: CorneaL epithelial autograft Device: Femtosecond laser Procedure: Limbal autograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Non-randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Limbal Dermoid
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
Experimental: Corneal epithelial autograft
Corneal dermoid tumor resection combined with femtosecond laser assisted corneal epithelial autograft
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

Active Comparator: Limbal autograft
Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft
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




Primary Outcome Measures :
  1. Restoration of corneal surface [ Time Frame: 1 year ]
    Restoration of a completely epithelized, stable, and avascular corneal surface.


Secondary Outcome Measures :
  1. Cosmetic improvement [ Time Frame: 1 year ]
    A grading system from 0 to 4 with slit-lamp photographs will be used to determine cosmetic result of each graft.

  2. Corneal Thickness [ Time Frame: 1 year ]
    To measure corneal thickness using anterior segment optical coherence tomography.

  3. Best corrected visual acuity [ Time Frame: 1 year ]
    To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.

  4. Corneal power, astigmatism and aberration [ Time Frame: 1 year ]
    To measure the changes of corneal power, astigmatism and aberration using autorefractor keratometer and wavefront aberrometer respectively.

  5. Density of stromal nerve and stromal keratocytes [ Time Frame: 1 year ]
    To assess the stromal nerve and stromal keratocytes using in vivo confocal microscopy.

  6. Corneal haze [ Time Frame: 1 year ]
    To assess corneal haze using in vivo confocal microscopy.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217461


Contacts
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Contact: Yingfeng Zheng, M.D.Ph.D. +8613922286455 yingfeng.zheng@qq.com

Locations
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China, Guangdong
Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity Recruiting
Guangzhou, Guangdong, China
Contact: Yingfeng Zheng, M.D. Ph.D.         
Sponsors and Collaborators
Chunxiao Wang
Investigators
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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

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Responsible Party: Chunxiao Wang, Clinical investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03217461     History of Changes
Other Study ID Numbers: 2017KYPJ056
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermoid Cyst
Cysts
Neoplasms
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type