Keratoconus
Conditions
Keywords
Keratoconus, Crosslinking, Toric ICL
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.
Interventions
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.
Sponsors
Shahid Beheshti University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 38 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual acuity (UCVA,BCVA) by Snellen chart | Up to 4 years after surgery |
Secondary
| 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 |
Countries
Iran
Contacts
Primary ContactFarideh Doroodgar, MD
Outcome results
None listed