Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03262285
Recruitment Status : Not yet recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):
Rawda Abdelnaser, Assiut University

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

Condition or disease Intervention/treatment
Senile Cataract Procedure: phacoemulsification Procedure: extracapsular cataract extraction

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
Estimated Enrollment : 70 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction in Management of Senile Cataract
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with senile cataract

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03262285

Contact: Ahmed Abu-Ghadir, professor 00201111337316
Contact: Ahmed Abdelhameed, lecturar 00201013002887

Sponsors and Collaborators
Assiut University
Study Chair: Ali Ryad, professor Assiut University


Responsible Party: Rawda Abdelnaser, resident, Assiut University Identifier: NCT03262285     History of Changes
Other Study ID Numbers: CECLPEECCE
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Corneal Endothelial Cell Loss
Lens Diseases
Eye Diseases
Corneal Diseases
Postoperative Complications
Pathologic Processes