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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (UCVA,BCVA) by Snellen chart | Up to 4 years after surgery |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farideh Doroodgar, MD | Contact | farinaz_144@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Farideh Doroodgar | Recruiting | Tehran | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29354720 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 16, 2020 | |
| Reset | Mar 27, 2020 | |
| Release | Apr 5, 2020 | |
| Reset | Apr 15, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 16, 2020 | Mar 27, 2020 | |||
| Apr 5, 2020 |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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|
| 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 |
| Apr 15, 2020 |