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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

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

Condition or disease Intervention/treatment Phase
Keratoconus Procedure: Simultaneous Lenticule Impanation (SLI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Stromal Enhancement in Keratoconus, Using Stromal Lenticules of Myopic SMILE Patients (Simultaneously)
Actual Study Start Date : March 30, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donat lenticul Procedure: Simultaneous Lenticule Impanation (SLI)
Increase cornea stromal thickness in patients with advance ectasia by donor lenticule created during small incision lenticule extraction (SMILE)




Primary Outcome Measures :
  1. visual acuity [ Time Frame: 6 months ]
    Visual acuity (VA) commonly refers to the clarity of vision



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03890718


Locations
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Iran, Islamic Republic of
Farideh Doroodgar
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
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Study Chair: Jorge Alio, MD,PhD Division of Ophthalmology, Universidad Miguel Hernández, Alicante, Spain
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Responsible Party: farinaz doroodgar, Clinical Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT03890718    
Other Study ID Numbers: ShaheidBU
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: December 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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Keratoconus
Corneal Diseases
Eye Diseases