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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04965168

Enrollment

Registered

2021-07-16

Start date

2020-12-01

Completion date

2021-10-16

Last updated

2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudoexfoliation

Keywords

DM, phacoemulsification, endothelial cell density

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.

Interventions

PROCEDUREphacoemulsification of the lens

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026