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OpenTrials
Completed

NCT Number: NCT04965168

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

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.

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Key information

Conditions

Pseudoexfoliation

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ophthalmology department/ Minia University Hospital/Minia University

Minya, 61111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

phacoemulsification of the lens

Procedure

all patients underwent phacoemulsification and IOL implantation for immature cataract extraction

Primary outcomes

  1. endothelial cell density

    Time frame: 6 months

    number of endothelial cells

  2. Percentage of hexagonal cells

    Time frame: 6 months

    indicator of healthy endothelial cells

  3. coefficient of variation (CV)

    Time frame: 6 months

    indicator of the uniformity of the size of endothelial cells

  4. Central corneal thickness

    Time frame: 6 months

    measurement of the distance between the epithelium and endothelium at the central cornea

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 16, 2021
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.