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

NCT04965168 | Completed

• 1 other identifier: 691:11/2020
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pseudoexfoliation

Keywords

DM; phacoemulsification; endothelial cell density

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (4)

controls

ACTIVE COMPARATOR

phacoemulsification and IOL implantation

Procedure: phacoemulsification of the lens

diabetic without pseudoexfoliation

ACTIVE COMPARATOR

phacoemulsification and IOL implantation

Procedure: phacoemulsification of the lens

non-diabetic with pseudoexfoliation

ACTIVE COMPARATOR

phacoemulsification and IOL implantation

Procedure: phacoemulsification of the lens

diabetic with pseudoexfoliation

ACTIVE COMPARATOR

phacoemulsification and IOL implantation

Procedure: phacoemulsification of the lens

Interventions

phacoemulsification of the lens PROCEDURE

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

controls; diabetic with pseudoexfoliation; diabetic without pseudoexfoliation; non-diabetic with pseudoexfoliation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Ophthalmology department/ Minia University Hospital/Minia University

Minya, 61111, Egypt

Location

Related Publications (6)

• 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.

  PMID: 23387877 BACKGROUND

• 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.

  PMID: 30056522 BACKGROUND

• 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.

  PMID: 26677035 BACKGROUND

• 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.

  PMID: 32451432 BACKGROUND

• 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.

  PMID: 20456430 BACKGROUND

• Mahmoud MSE, Omar IAN, AttaAllah HR. Evaluation of the corneal thickness and endothelial changes following uncomplicated phacoemulsification in diabetic and non-diabetic patients with pseudo-exfoliation syndrome by specular microscopy. Int Ophthalmol. 2023 Dec;43(12):4773-4780. doi: 10.1007/s10792-023-02877-x. Epub 2023 Sep 18.

  PMID: 37721703 DERIVED

Study Officials

• Heba R AttaAllah, MD

  Faculty of Medicine, Minia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: December 1, 2020
• Primary Completion: October 12, 2021
• Study Completion: October 16, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)