Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

Completed

• Conditions: Senile Cataract
• Interventions: Procedure: phacoemulsification; Procedure: extracapsular cataract extraction

• Registration Number: NCT03262285
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-08-23
• Study First Posted: 2017-08-25
• Study Start: 2018-07-01
• Status Verified: 2020-05
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
phacoemulsification	phacoemulsification	patients undergoing phacoemulsification surgery for senile cataract
extracapsular cataract extraction	extracapsular cataract extraction	patients undergoing extracapsular cataract extraction surgery for senile cataract

Primary Outcome Measures

Name	Time	Method
percentage of endothelial cell loss	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 Outcome Measures

Name	Time	Method
changes in shape of endothelial cell	5 minutes	specular microscopy will be done to identify changes in hexagonality of endothelial cells after the intervention

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt