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

This study is currently recruiting participants.
Verified July 2016 by Farideh Doroodgar, Shahid Beheshti University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833649
First Posted: July 14, 2016
Last Update Posted: July 15, 2016
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.
Information provided by (Responsible Party):
Farideh Doroodgar, Shahid Beheshti University
  Purpose
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.

Condition Intervention
Keratoconus Device: Toric Implantable collamer Lens

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).

Resource links provided by NLM:


Further study details as provided by Farideh Doroodgar, Shahid Beheshti University:

Primary Outcome Measures:
  • Visual acuity (UCVA,BCVA) by Snellen chart [ Time Frame: Up to 4 years after surgery ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

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Ages Eligible for Study:   25 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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): NCT02833649


Contacts
Contact: Farideh Doroodgar, MD farinaz_144@yahoo.com

Locations
Iran, Islamic Republic of
Farideh Doroodgar Recruiting
Tehran, Iran, Islamic Republic of
Contact: Farideh Doroodgar, MD    +989125259912    farinaz_144@yahoo.com   
Sponsors and Collaborators
Shahid Beheshti University
  More Information

Responsible Party: Farideh Doroodgar, Clinical Professor, Shahid Beheshti University
ClinicalTrials.gov Identifier: NCT02833649     History of Changes
Other Study ID Numbers: ShaheedBU
First Submitted: July 4, 2016
First Posted: July 14, 2016
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Farideh Doroodgar, Shahid Beheshti University:
Keratoconus
Crosslinking
Toric ICL

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases