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

Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).

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.

Study Overview

• Status: Unknown
• Conditions: Keratoconus
• Intervention / Treatment: Device: Toric Implantable collamer Lens

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Farideh Doroodgar
    • Contact: Farideh Doroodgar, MD; Phone Number: +989125259912; Email: farinaz_144@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: TICL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual acuity (UCVA,BCVA) by Snellen chart	Up to 4 years after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Refractive error by Auto Kerato-Refractometer	Until 4 years after surgery
Defocus curve by Phoropter	Up to 4 years after surgery
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire	up to 4 years after surgery
Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.	up to 4 years after surgery
Aberrometry by Ray Tracing	Up to 4 years after surgery

Collaborators and Investigators

• Sponsor: Shahid Beheshti University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 4, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (Estimate): July 14, 2016

Study Record Updates

• Last Update Posted (Estimate): July 15, 2016
• Last Update Submitted That Met QC Criteria: July 14, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Keratoconus; Crosslinking; Toric ICL
• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: ShaheedBU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided