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

Not Applicable

Completed

• Conditions: Pseudoexfoliation
• Interventions: Procedure: phacoemulsification of the lens

• Registration Number: NCT04965168
• Lead Sponsor: Minia University

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.

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 Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-16
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-16
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetic without pseudoexfoliation	phacoemulsification of the lens	phacoemulsification and IOL implantation
controls	phacoemulsification of the lens	phacoemulsification and IOL implantation
diabetic with pseudoexfoliation	phacoemulsification of the lens	phacoemulsification and IOL implantation
non-diabetic with pseudoexfoliation	phacoemulsification of the lens	phacoemulsification and IOL implantation

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ophthalmology department/ Minia University Hospital/Minia University; 🇪🇬 Minya, Egypt