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

Not Applicable

• Conditions: Keratoconus
• Interventions: Device: Toric Implantable collamer Lens

• Registration Number: NCT02833649
• Lead Sponsor: Shahid Beheshti University

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 available

Study Timeline

• Study Start: 2011-12
• Status Verified: 2016-07
• Study First Submitted: 2016-07-04
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-14
• Last Update Submitted: 2016-07-14
• Last Update Posted: 2016-07-15
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toric Implantable contact Lens	Toric Implantable collamer 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

Primary Outcome Measures

Name	Time	Method
Visual acuity (UCVA,BCVA) by Snellen chart	Up to 4 years after surgery

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire	up to 4 years after surgery
Refractive error by Auto Kerato-Refractometer	Until 4 years after surgery
Defocus curve by Phoropter	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

Trial Locations

Locations (1)

Farideh Doroodgar; 🇮🇷 Tehran, Iran, Islamic Republic of