Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

January 25, 2021 updated by: Rawda Abdelnaser, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with senile cataract

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
phacoemulsification
patients undergoing phacoemulsification surgery for senile cataract
Procedure: phacoemulsification
removal of cataract using ultrasound waves
extracapsular cataract extraction
patients undergoing extracapsular cataract extraction surgery for senile cataract
Procedure: extracapsular cataract extraction
removal of cataract using surgical corneal incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ali Ryad, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

August 23, 2017

First Submitted That Met QC Criteria

August 23, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CECLPEECCE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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