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Completed

NCT Number: NCT03262285

Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

the investigators will compare between the endothelial cell loss after phacoemulsification and extracapsular cataract extraction in management of senile cataract

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Key information

Conditions

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university

Asyut, Egypt

About this study

Age related cataract is believed to be the main cause of reversible blindness worldwide and in developing countries. Population-based studies have reported that cataract is responsible for 47.8% to 51% of all global blindness.

Several studies compared phacoemulsification and conventional extracapsular cataract extraction regarding several aspects such as postoperative inflammation and visual rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less astigmatism and better postoperative vision .However, Extracapsular cataract extraction is still the operation of choice in some cataract cases.

The normal corneal endothelium is a single layer of uniformly sized cells with a predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the space as the cells cannot regenerate.The minimum cell density necessary for adequate function is in the range of 400 to 700 cells/mm2.

The effect of cataract surgery on corneal endothelium is an important factor that affects postoperative vision .However, it is accepted all over the world that there is definite loss of some endothelial cells with all techniques of cataract surgery. Previously, cataract surgery caused enormous loss of endothelial cells , but with enhancement of equipment and surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.

Specular microscopy is a noninvasive photographic technique that allows visualization and analysis of corneal endothelium. specular microscopy is used to show cell count and cell shape in the scanned area.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Cases of senile cataract of both sexes will be included in this study

Exclusion criteria

  • Corneal endothelial pathologies such as Fuch's dystrophy
  • Complicated cataract
  • Cataract with history of trauma
  • Coexisting eye pathology

Treatment and study plan

phacoemulsification

Procedure

removal of cataract using ultrasound waves

extracapsular cataract extraction

Procedure

removal of cataract using surgical corneal incision

Primary outcomes

  1. percentage of endothelial cell loss

    Time frame: 5 minutes

    specular microscopy will be done to measure the endothelial cell count before and after the intervention to measure the percentage of loss

Secondary outcomes

  1. changes in shape of endothelial cell

    Time frame: 5 minutes

    specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2017
Registry last updated
Jan 27, 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.

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