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

Shahid Beheshti University

Status: Unknown

Conditions: Keratoconus

Treatments: Device: Toric Implantable collamer Lens

Study type: Interventional

Funder types: Other

Identifiers

NCT02833649

ShaheedBU

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Toric Implantable contact Lens

Experimental group

Description:

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

Treatment:

Device: Toric Implantable collamer Lens