Clinical trial NCT02833649: Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
Official title: Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Keratoconus
Keywords: Keratoconus
Crosslinking
Toric ICL
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Visual acuity (UCVA,BCVA) by Snellen chart
timeFrame: Up to 4 years after surgery
Secondary outcomes:
measure: Refractive error by Auto Kerato-Refractometer
timeFrame: Until 4 years after surgery
measure: Defocus curve by Phoropter
timeFrame: Up to 4 years after surgery
measure: Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire
timeFrame: up to 4 years after surgery
measure: Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.
timeFrame: up to 4 years after surgery
measure: Aberrometry by Ray Tracing
timeFrame: Up to 4 years after surgery
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Farideh Doroodgar
Study officials:
References:
citation: 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.