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

Keratoconus Clinical Trial

— TICL  

Official title:

Comparative Analysis of the Visual Performance in Patients With Stable Keratoconus After Implantation of the Toric Implantable Collamer Lens (TICL).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02833649
• Other study ID #: ShaheedBU
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2016
• Last updated: July 14, 2016
• Start date: December 2011
• Est. completion date: December 2016

Study information

• Verified date: July 2016
• Source: Shahid Beheshti University
• Contact: Farideh Doroodgar, MD
• Email: farinaz_144[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of HealthIran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 38 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• Toric Implantable collamer Lens
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Farideh Doroodgar	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity (UCVA,BCVA) by Snellen chart		Up to 4 years after surgery	Yes
Secondary	Refractive error by Auto Kerato-Refractometer		Until 4 years after surgery	Yes
Secondary	Defocus curve by Phoropter		Up to 4 years after surgery	Yes
Secondary	Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire		up to 4 years after surgery	Yes
Secondary	Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.		up to 4 years after surgery	Yes
Secondary	Aberrometry by Ray Tracing		Up to 4 years after surgery	Yes