Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03262285
Collaborator
(none)
70
1
30.5
2.3

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual 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
Actual Study Start Date :
Jul 1, 2018
Actual Primary Completion Date :
Jan 1, 2021
Actual Study Completion Date :
Jan 15, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. changes in shape of endothelial cell [5 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut university Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Chair: Ali Ryad, professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rawda Abdelnaser, resident, Assiut University
ClinicalTrials.gov Identifier:
NCT03262285
Other Study ID Numbers:
  • CECLPEECCE
First Posted:
Aug 25, 2017
Last Update Posted:
Jan 27, 2021
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2021