Changes of the Corneal Endothelial Cell Count After Artisan Phakic Intraocular Lens Implantation

NCT03266354 | Completed

• 1 other identifier: CECCAPIOL
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

High Myopia

Keywords

Artisan

Outcome Measures

Primary Outcomes (1)

• Changes in the Corneal endothelial cell count after Artisan phakic intraocular lens implantation

  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.

  5 minutes

Interventions

specular microscopy before and after Artisan PIOL PROCEDURE

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

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with Artisan PIOL

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Fculty of medicine, Assiut university

Asyut, Egypt

Location

Related Publications (10)

• 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.

  PMID: 14967266 BACKGROUND

• 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.

  PMID: 9352483 BACKGROUND

• 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.

  PMID: 9719962 BACKGROUND

• 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.

  PMID: 17466848 BACKGROUND

• STOCKER FW. The endothelium of the cornea and its clinical implications. Trans Am Ophthalmol Soc. 1953;51:669-786. No abstract available.

  PMID: 13216798 BACKGROUND

• Mishima S. Clinical investigations on the corneal endothelium. Ophthalmology. 1982 Jun;89(6):525-30. doi: 10.1016/s0161-6420(82)34755-7.

  PMID: 6750487 BACKGROUND

• 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.

  PMID: 7122038 BACKGROUND

• 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.

  PMID: 16054624 BACKGROUND

• 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.

  PMID: 5721120 BACKGROUND

• 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.

  PMID: 1115675 BACKGROUND

Study Officials

• gamal rashed, professor

  Assiut University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: October 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: January 20, 2021

Record last verified: 2020-05

Locations

EG (1)