Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
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|ClinicalTrials.gov Identifier: NCT03266354|
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment|
|High Myopia||Procedure: specular microscopy before and after Artisan PIOL|
Iris-fixated phakic intraocular lenses (pIOLs) are used worldwide to correct high myopia, hyperopia, and astigmatism. It is used to correct high degrees of myopia in patients for whom laser excimer refractive surgery is not indicated.
The Artisan lens is designed to minimize the contact between the iris and the IOL resulting in less halo and glare from the prism effect.
Several clinical studies show that the visual results of the Artisan lens are stable and predictable. Artisan phakic IOLs provides precise predictability.
There have been concerns that the anterior chamber lens could damage the endothelial cell layer because of its proximity to the cornea. The manufacturer advises using the Artisan lens only in eyes with an ECD greater than 2000 cells/mm2 and an ACD greater than 2.6 mm.
Corneal endothelium is metabolically active and responsible for keeping the corneal stroma in its usual dehydrated state of 70% water.
loss of endothelial cells from increasing age, trauma, disease, or corneal surgery can reduce the density of endothelial cells and affect the ability of the endothelium to maintain it's primary function.
Alterations in the corneal endothelium depend on surgical technique and style; although endothelial cell loss is mainly the result of surgical trauma, continuous endothelial cell loss can occur. Late corneal decompensation often occurs in the absence of direct intraoperative endothelial trauma. These complications can be explained by the toxic effect of inflammatory mediators on the corneal endothelium.
Specular microscopy is used to view and record non-invasively the image of the corneal endothelial cell layer.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation|
|Estimated Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||January 1, 2020|
- Procedure: specular microscopy before and after Artisan PIOL
specular microscopy will be performed before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count
- Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation [ Time Frame: 5 minutes ]specular microscopy will be performed on a number of myopic patients before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266354
|Contact: ashraf khalaf, professor||00201223164661||Ashrafka2@yahoo.com|
|Contact: mahmoud fathy, firstname.lastname@example.org|
|Study Chair:||gamal rashed, professor||Assiut University|