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

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

Tracking Information

• First Submitted Date: July 4, 2016
• First Posted Date: July 14, 2016
• Last Update Posted Date: July 15, 2016
• Study Start Date: December 2011
• Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 13, 2016): Visual acuity (UCVA,BCVA) by Snellen chart [ Time Frame: Up to 4 years after surgery ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Keratoconus

Intervention

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

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.

Recruitment Information

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

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 38 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT02833649
• Other Study ID Numbers: ShaheedBU
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Farideh Doroodgar, Shahid Beheshti University
• Study Sponsor: Shahid Beheshti University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shahid Beheshti University
• Verification Date: July 2016