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

Pseudoexfoliation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965168
• Other study ID #: 691:11/2020
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: October 16, 2021

Study information

• Verified date: November 2021
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 16, 2021
• Est. primary completion date: October 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pseudoexfoliation

Intervention

Procedure:
• phacoemulsification of the lens
all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Locations

Country	Name	City	State
Egypt	Ophthalmology department/ Minia University Hospital/Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View Citation

Fernández-Muñoz 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. — View Citation

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. — View Citation

Quiroga L, Lansingh VC, Samudio M, Peña 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. — View Citation

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. — View Citation

Outcome

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