Back to resultsComparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus (TICL)
Primary Purpose
Keratoconus
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Toric Implantable collamer Lens
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Crosslinking, Toric ICL
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.
Sites / Locations
- Farideh DoroodgarRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Toric Implantable contact Lens
Arm Description
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
Outcomes
Primary Outcome Measures
Visual acuity (UCVA,BCVA) by Snellen chart
Secondary Outcome Measures
Refractive error by Auto Kerato-Refractometer
Defocus curve by Phoropter
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire
Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.
Aberrometry by Ray Tracing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02833649
Brief Title
Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
Acronym
TICL
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
Keratoconus, Crosslinking, Toric ICL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Toric Implantable contact Lens
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Toric Implantable collamer Lens
Other Intervention Name(s)
TICL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual acuity (UCVA,BCVA) by Snellen chart
Time Frame
Up to 4 years after surgery
Secondary Outcome Measure Information:
Title
Refractive error by Auto Kerato-Refractometer
Time Frame
Until 4 years after surgery
Title
Defocus curve by Phoropter
Time Frame
Up to 4 years after surgery
Title
Patient satisfaction to measure the patients' subjective assessment of visual improvement by a validated questionnaire
Time Frame
up to 4 years after surgery
Title
Contrast sensitivity by MediWorks C901 Acuity Chart (Shanghai MediWorks Precision Instruments Co, Ltd, Shanghai, China.
Time Frame
up to 4 years after surgery
Title
Aberrometry by Ray Tracing
Time Frame
Up to 4 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farideh Doroodgar, MD
Email
farinaz_144@yahoo.com
Facility Information:
Facility Name
Farideh Doroodgar
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farideh Doroodgar, MD
Phone
+989125259912
Email
farinaz_144@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29354720
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.
Results Reference
derived
Learn more about this trial
Comparative Analysis of the Visual Performance After TICL Implantation in Patients With Stable Keratoconus
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