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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
Sponsor:
Information provided by (Responsible Party):
Mohamed Omar, Assiut University

Brief Summary:
the investigator will evaluate the change in endothelial cell count in eyes implanted with the iris-claw phakic Artisan lens for treatment of moderate to high myopia using specular microscopy

Condition or disease Intervention/treatment
High Myopia Procedure: specular microscopy before and after Artisan PIOL

Detailed Description:

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
Observational Model: Case-Only
Time Perspective: Prospective
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

Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Artisan PIOL
Criteria

Inclusion Criteria:

  • an age greater than 20 years, stable myopia with a variation in spherical equivalent of less than -0.50 diopter (D) during the 12 month preoperative period, a normal anterior segment with an ACD (i.e., the area between the corneal endothelium and the central anterior lens capsule) greater than 3.00 mm, an endothelial cell count of 2000 cells/mm2 or greater, no corneal, pupil, or iris abnormalities; and no history of glaucoma and chronic or recurrent uveitis , having contraindications to laser in situ keratomileusis based on pachymetric data or other corneal shape characteristics, and an intraocular pressure of 20 mm Hg or less.

Exclusion Criteria:

  • an ACD less than 3.0 mm, history of ocular surgery, glaucoma, chronic uveitis, or preexisting ocular pathologic features or abnormalities.

Information from the National Library of Medicine

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


Contacts
Contact: ashraf khalaf, professor 00201223164661 Ashrafka2@yahoo.com
Contact: mahmoud fathy, lecturer 02201008348480 rateb@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
Study Chair: gamal rashed, professor Assiut University

Publications:
Responsible Party: Mohamed Omar, resident, Assiut University
ClinicalTrials.gov Identifier: NCT03266354     History of Changes
Other Study ID Numbers: CECCAPIOL
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mohamed Omar, Assiut University:
Artisan