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Corneal Epithelial Autograft for Limbal Dermoid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE July 18, 2017
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
Restoration of corneal surface [ Time Frame: 1 year ]
Restoration of a completely epithelized, stable, and avascular corneal surface.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • 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.
  • Corneal Thickness [ Time Frame: 1 year ]
    To measure corneal thickness using anterior segment optical coherence tomography.
  • Best corrected visual acuity [ Time Frame: 1 year ]
    To measure best corrected visual acuity using ETDRS chart or Teller Acuity Cards.
  • 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.
  • Density of stromal nerve and stromal keratocytes [ Time Frame: 1 year ]
    To assess the stromal nerve and stromal keratocytes using in vivo confocal microscopy.
  • Corneal haze [ Time Frame: 1 year ]
    To assess corneal haze using in vivo confocal microscopy.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Corneal Epithelial Autograft for Limbal Dermoid
Official Title  ICMJE A Non-randomized Controlled Clinical Trial of Corneal Epithelial Autograft for Limbal Dermoid
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Corneal Dermoid
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Corneal epithelial autograft
    Corneal dermoid tumor resection combined with femtosecond laser assisted corneal epithelial autograft
    Interventions:
    • Procedure: CorneaL epithelial autograft
    • Device: Femtosecond laser
  • Active Comparator: Limbal autograft
    Corneal dermoid tumor resection combined with femtosecond laser assisted limbal autograft
    Interventions:
    • Procedure: Limbal autograft
    • Device: Femtosecond laser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 12, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yingfeng Zheng, M.D.Ph.D. +8613922286455 yingfeng.zheng@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03217461
Other Study ID Numbers  ICMJE 2017KYPJ056
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chunxiao Wang, Sun Yat-sen University
Study Sponsor  ICMJE Chunxiao Wang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Sun Yat-sen University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP