Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation
NCT ID: NCT03266354
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
12 participants
OBSERVATIONAL
2017-10-01
2020-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Corneal Endothelial Assessment After Posterior Chamber Phakic Intraocular Lens Implantation
NCT06849375
Anterior Versus Posterior Artisan Intraocular Lens Fixation in Aphakic Children With Insufficient Capsular Support.
NCT06396156
Implantable Phakic Lens (IPCL) VS Implantable Collamer Lens
NCT04624035
Intraocular Lens Power Calculation for Combined Phaco-vitrectomy Procedures
NCT03856346
Visual Acuity After Using A New Monofocal Intraocular Lens Compared To Standard Monofocal Lens
NCT05430295
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Omar
resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
gamal rashed, professor
Role: STUDY_CHAIR
Assiut University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fculty of medicine, Assiut university
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Menezo JL, Peris-Martinez C, Cisneros AL, Martinez-Costa R. Phakic intraocular lenses to correct high myopia: Adatomed, Staar, and Artisan. J Cataract Refract Surg. 2004 Jan;30(1):33-44. doi: 10.1016/j.jcrs.2003.11.023.
Menezo JL, Avino JA, Cisneros A, Rodriguez-Salvador V, Martinez-Costa R. Iris claw phakic intraocular lens for high myopia. J Refract Surg. 1997 Sep-Oct;13(6):545-55. doi: 10.3928/1081-597X-19970901-11.
Menezo JL, Cisneros AL, Rodriguez-Salvador V. Endothelial study of iris-claw phakic lens: four year follow-up. J Cataract Refract Surg. 1998 Aug;24(8):1039-49. doi: 10.1016/s0886-3350(98)80096-5.
Benedetti S, Casamenti V, Benedetti M. Long-term endothelial changes in phakic eyes after Artisan intraocular lens implantation to correct myopia: five-year study. J Cataract Refract Surg. 2007 May;33(5):784-90. doi: 10.1016/j.jcrs.2007.01.037.
STOCKER FW. The endothelium of the cornea and its clinical implications. Trans Am Ophthalmol Soc. 1953;51:669-786. No abstract available.
Mishima S. Clinical investigations on the corneal endothelium. Ophthalmology. 1982 Jun;89(6):525-30. doi: 10.1016/s0161-6420(82)34755-7.
Waring GO 3rd, Bourne WM, Edelhauser HF, Kenyon KR. The corneal endothelium. Normal and pathologic structure and function. Ophthalmology. 1982 Jun;89(6):531-90.
Joyce NC. Cell cycle status in human corneal endothelium. Exp Eye Res. 2005 Dec;81(6):629-38. doi: 10.1016/j.exer.2005.06.012. Epub 2005 Jul 28.
Maurice DM. Cellular membrane activity in the corneal endothelium of the intact eye. Experientia. 1968 Nov 15;24(11):1094-5. doi: 10.1007/BF02147776. No abstract available.
Laing RA, Sandstrom MM, Leibowitz HM. In vivo photomicrography of the corneal endothelium. Arch Ophthalmol. 1975 Feb;93(2):143-5. doi: 10.1001/archopht.1975.01010020149013.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CECCAPIOL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.