Corneal Endothelium Evaluation After Phacoemulsification in Diabetec and Non-diabetic Patients With Pseudoexfoliation

Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy

Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.

Study Overview

• Status: Completed
• Conditions: Pseudoexfoliation
• Intervention / Treatment: Procedure: phacoemulsification of the lens

Detailed Description

Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61111
    • Ophthalmology department/ Minia University Hospital/Minia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Senile cataract with age between 50 to 70 years
• Clear cornea with no zonuler dehiscence
• Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)

Exclusion Criteria:

• Uncontrolled DM in diabetic groups
• Presence of autoimmune diseases
• Patients with glaucoma
• Corneal guttata
• Zonular dehiscence
• Rupture posterior capsule during cataract surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: controls; phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
ACTIVE_COMPARATOR: diabetic without pseudoexfoliation; phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
ACTIVE_COMPARATOR: non-diabetic with pseudoexfoliation; phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction
ACTIVE_COMPARATOR: diabetic with pseudoexfoliation; phacoemulsification and IOL implantation	Procedure: phacoemulsification of the lens; all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelial cell density	number of endothelial cells	6 months
Percentage of hexagonal cells	indicator of healthy endothelial cells	6 months
coefficient of variation (CV)	indicator of the uniformity of the size of endothelial cells	6 months
Central corneal thickness	measurement of the distance between the epithelium and endothelium at the central cornea	6 months

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Principal Investigator: Heba R AttaAllah, MD, Faculty of Medicine, Minia University

Publications and helpful links

General Publications

• Storr-Paulsen A, Singh A, Jeppesen H, Norregaard JC, Thulesen J. Corneal endothelial morphology and central thickness in patients with type II diabetes mellitus. Acta Ophthalmol. 2014 Mar;92(2):158-60. doi: 10.1111/aos.12064. Epub 2013 Feb 7.
• Fernandez-Munoz E, Zamora-Ortiz R, Gonzalez-Salinas R. Endothelial cell density changes in diabetic and nondiabetic eyes undergoing phacoemulsification employing phaco-chop technique. Int Ophthalmol. 2019 Aug;39(8):1735-1741. doi: 10.1007/s10792-018-0995-y. Epub 2018 Jul 28.
• Oltulu R, Satirtav G, Kayitmazbatir ET, Bitirgen G, Ozkagnici A, Karaibrahimoglu A. Characteristics of the cornea in patients with pseudoexfoliation syndrome. Arq Bras Oftalmol. 2015 Nov-Dec;78(6):348-51. doi: 10.5935/0004-2749.20150092.
• Aoki T, Kitazawa K, Inatomi T, Kusada N, Horiuchi N, Takeda K, Yokoi N, Kinoshita S, Sotozono C. Publisher Correction: Risk Factors for Corneal Endothelial Cell Loss in Patients with Pseudoexfoliation Syndrome. Sci Rep. 2020 May 26;10(1):8800. doi: 10.1038/s41598-020-66089-4.
• Quiroga L, Lansingh VC, Samudio M, Pena FY, Carter MJ. Characteristics of the corneal endothelium and pseudoexfoliation syndrome in patients with senile cataract. Clin Exp Ophthalmol. 2010 Jul;38(5):449-55. doi: 10.1111/j.1442-9071.2010.02313.x. Epub 2010 Apr 28.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): October 12, 2021
• Study Completion (ACTUAL): October 16, 2021

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (ACTUAL): July 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: phacoemulsification; DM; endothelial cell density
• Other Study ID Numbers: 691:11/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No