Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keā¦ (NCT02833649) | Clinical Trial Compass
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Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
Iran24 participantsStarted 2011-12
Plain-language 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.
Who can participate
Age range25 Years ā 38 Years
SexALL
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Inclusion Criteria:
* age (25-38).
* Stable refraction was distinctive by 6 subjective refractions within Ā± 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 30Ā°, a pupil diameter of less than 6.25 mm.
Exclusion Criteria:
* Patients with central corneal thickness of less than 450 Ī¼m.
* 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 Ī¼m would account for around 400 Ī¼m 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.