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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pseudoexfoliation

Intervention / Treatment
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* Procedure: phacoemulsification of the lens


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: controls<br>phacoemulsification and IOL implantation | Procedure: phacoemulsification of the lens<br>* all patients underwent phacoemulsification and IOL implantation for immature cataract extraction<br>|
| Active Comparator: diabetic without pseudoexfoliation<br>phacoemulsification and IOL implantation | Procedure: phacoemulsification of the lens<br>* all patients underwent phacoemulsification and IOL implantation for immature cataract extraction<br>|
| Active Comparator: non-diabetic with pseudoexfoliation<br>phacoemulsification and IOL implantation | Procedure: phacoemulsification of the lens<br>* all patients underwent phacoemulsification and IOL implantation for immature cataract extraction<br>|
| Active Comparator: diabetic with pseudoexfoliation<br>phacoemulsification and IOL implantation | Procedure: phacoemulsification of the lens<br>* all patients underwent phacoemulsification and IOL implantation for immature cataract extraction<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DM, phacoemulsification, endothelial cell density