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Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus (TICL)

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ClinicalTrials.gov Identifier: NCT02833649
Recruitment Status : Unknown
Verified July 2016 by Farideh Doroodgar, Shahid Beheshti University.
Recruitment status was:  Recruiting
First Posted : July 14, 2016
Last Update Posted : July 15, 2016
Sponsor:
Information provided by (Responsible Party):
Farideh Doroodgar, Shahid Beheshti University

Tracking Information
First Submitted Date  ICMJE July 4, 2016
First Posted Date  ICMJE July 14, 2016
Last Update Posted Date July 15, 2016
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
Visual acuity (UCVA,BCVA) by Snellen chart [ Time Frame: Up to 4 years after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2016)
  • Refractive error by Auto Kerato-Refractometer [ Time Frame: Until 4 years after surgery ]
  • Defocus curve by Phoropter [ Time Frame: Up to 4 years after surgery ]
  • Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire [ Time Frame: up to 4 years after surgery ]
  • Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China. [ Time Frame: up to 4 years after surgery ]
  • Aberrometry by Ray Tracing [ Time Frame: Up to 4 years after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2016)
  • Refractive error by Auto Kerato-Refractometer [ Time Frame: Until 4 years after surgery ]
  • Defocus curve by Phoropter [ Time Frame: Up to 4 years after surgery ]
  • Patient satisfaction for measure the patients' subjective assessment of visual improvement. [ Time Frame: up to 4 years after surgery ]
  • Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China. [ Time Frame: up to 4 years after surgery ]
  • Aberrometry by Ray Tracing [ Time Frame: Up to 4 years after surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
Official Title  ICMJE Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).
Brief Summary To report on 4-year postoperative safety, efficacy, stability and predictability outcomes(to evaluate the visual, refractive, contrast sensitivity, defocus curve and aberrometric data preoperation, and compare with a similar postoperative outcomes) with the Toric Implantable Contact Lens (TICL) for Stable keratoconus. Investigators will study the four-year follow-up from this standardized, multi-center clinical investigation, support from clinical and optical viewpoints TICL implantation, in stable keratoconus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Keratoconus
Intervention  ICMJE Device: Toric Implantable collamer Lens
The toric implantable collamer lens (TICL) is conventionally indicated for the Correcting the refractive error in keratoconus using the TICL is an off label use of the lens.
Other Name: TICL
Study Arms  ICMJE Experimental: Toric Implantable contact Lens
The Visian implantable collamer lens (Staar Surgical AG, Nidau, Switzerland), is a monoblock single-piece plate haptic lens made of collamer (an extremely hydrophilic and highly biocompatible flexible collagen copolymer with a refractive index of 1.452 that is permeable to oxygen and nutrients
Intervention: Device: Toric Implantable collamer Lens
Publications * Doroodgar F, Niazi F, Sanginabadi A, Niazi S, Baradaran-Rafii A, Alinia C, Azargashb E, Ghoreishi M. Comparative analysis of the visual performance after implantation of the toric implantable collamer lens in stable keratoconus: a 4-year follow-up after sequential procedure (CXL+TICL implantation). BMJ Open Ophthalmol. 2017 Sep 28;2(1):e000090. doi: 10.1136/bmjophth-2017-000090. eCollection 2017.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 13, 2016)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age (25-38).
  • Stable refraction was distinctive by 6 subjective refractions within ± 0.50 diopters(D) of spherical equivalent during 6 months after CXL.
  • best spectacle-corrected visual acuity (BCVA) of +0.4 LogMAR (20/40) or better, -clear central cornea.
  • normal anterior chamber depth at least 3 mm to endothelium .
  • intraocular pressure (IOP)<20 mm Hg and preoperative endothelial cell count related to age and the anterior chamber depth with regard to Food and Drug Administration recommendations.
  • Width of Angle greater than 30°, a pupil diameter of less than 6.25 mm.

Exclusion Criteria:

  • Patients with central corneal thickness of less than 450 μm.
  • endothelial cell count of less than 2,000 cells/mm2 .
  • anterior chamber depth of <3 mm from endothelium to anterior capsule .
  • Corneal opacification or scars, cataract, retinal detachment, glaucoma, retinopathy, macular degeneration, neuro ophthalmic diseases or ocular inflammation, history of keratitis (any form), peripheral marginal degeneration, previous corneal and/or intraocular surgeries, and autoimmune and/or connective tissue disease. The central corneal thickness limit of 450 μm would account for around 400 μm of remaining stromal thickness after removal of the epithelium, which is considered as the safety thickness for the residual stroma to avoid endothelial cell damage during the CXL procedure.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 38 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 NCT02833649
Other Study ID Numbers  ICMJE ShaheedBU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Farideh Doroodgar, Shahid Beheshti University
Study Sponsor  ICMJE Shahid Beheshti University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University
Verification Date July 2016

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