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Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously) (keratoconus)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890718
Recruitment Status : Enrolling by invitation
First Posted : March 26, 2019
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
farinaz doroodgar, Shahid Beheshti University

Tracking Information
First Submitted Date  ICMJE March 25, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date June 29, 2020
Actual Study Start Date  ICMJE March 30, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
visual acuity [ Time Frame: 6 months ]
Visual acuity (VA) commonly refers to the clarity of vision
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously)
Official Title  ICMJE Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously)
Brief Summary To investigate the feasibility, safety, and efficacy of using a donor lenticule created during small incision lenticule extraction (SMILE) in patients with advance keratoconus
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keratoconus
Intervention  ICMJE Procedure: Simultaneous Lenticule Impanation (SLI)
Increase cornea stromal thickness in patients with advance ectasia by donor lenticule created during small incision lenticule extraction (SMILE)
Study Arms  ICMJE Experimental: Donat lenticul
Intervention: Procedure: Simultaneous Lenticule Impanation (SLI)
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: December 7, 2019)
22
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
15
Estimated Study Completion Date  ICMJE December 15, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • visual dissatisfaction with spectacles
  • contact lens intolerance
  • Age of ≥ 21 years
  • Best Corrected Distance Visual Acuity (BCDVA) log MAR 0.6 (equivalent 20/40)
  • Maximum of 50 diopters of keratometry
  • Intraocular Pressure (IOP) of less than 20 mm Hg
  • corneal endothelial cell density proportional to the patient's age of at least 2000 mm²

Exclusion Criteria:

  • History of previous intraocular surgery
  • History of herpetic corneal infections
  • The presence of ocular diseases, such as glaucoma, active vernal kerato-conjunctivitis, intraocular inflammation, and retinal diseases except for KCN
  • Histories of systemic diseases, such as diabetes mellitus, immune deficiency, and collagen vascular disease, which could delay corneal wound healing
  • Drug history of sumatriptan, amiodarone, and isotretinoin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890718
Other Study ID Numbers  ICMJE ShaheidBU
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 farinaz doroodgar, Shahid Beheshti University
Study Sponsor  ICMJE Shahid Beheshti University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jorge Alio, MD,PhD Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
PRS Account Shahid Beheshti University
Verification Date December 2019

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