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

NCT02833649 | Unknown DMC

• 1 other identifier: ShaheedBU
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Keywords

Keratoconus; Crosslinking; Toric ICL

Outcome Measures

Primary Outcomes (1)

• Visual acuity (UCVA,BCVA) by Snellen chart

  Up to 4 years after surgery

Secondary Outcomes (5)

• 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

Study Arms (1)

Toric Implantable contact Lens

EXPERIMENTAL

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

Device: Toric Implantable collamer Lens

Interventions

Toric Implantable collamer Lens DEVICE

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.

Also known as: TICL

Toric Implantable contact Lens

Eligibility Criteria

• Age: 25 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Farideh Doroodgar

Tehran, Tehran Province, Iran

RECRUITING

Related Publications (1)

• 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.

  PMID: 29354720 DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Farideh Doroodgar, MD

CONTACT

farinaz_144@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 4, 2016
• First Posted: July 14, 2016
• Study Start: December 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 15, 2016

Record last verified: 2016-07

Locations

IR (1)