Back to resultsCorrelations Between Lens Star and Phacoemulsification.
Primary Purpose
Cataract, Lens Diseases, Lens Opacities
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Phacoemulsification
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract
Eligibility Criteria
Inclusion Criteria:
- patients that will undergone phacoemulsification for their mild to moderate senile cataracts.
Exclusion Criteria:
- congenital and developmental cataract.
- cases with congenital lens anomalies as ectopia lentis and spheophakia.
Sites / Locations
- Ahmed AbdelshafyRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lens star biometry
Arm Description
Biometry done prior to phacoemulsification
Outcomes
Primary Outcome Measures
Correlation between parameters measured by lens star.
Anterior chamber depth, lens, axial length, keratometry readings and age of the patients.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05290896
Brief Title
Correlations Between Lens Star and Phacoemulsification.
Official Title
Correlations Between Lens Star Parameters and Phacoemulsification in Clinical Practice.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
September 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess correlations between lens star biometry parameters and phacoemulsification in clinical practice.
Detailed Description
To analyze possible correlations between lens star biometry parameters and phacoemulsification in mild to moderate senile cataract.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Diseases, Lens Opacities
Keywords
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Senile cataract patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lens star biometry
Arm Type
Other
Arm Description
Biometry done prior to phacoemulsification
Intervention Type
Device
Intervention Name(s)
Phacoemulsification
Other Intervention Name(s)
Phaco
Intervention Description
Phacoemulsification for senile cataract.
Primary Outcome Measure Information:
Title
Correlation between parameters measured by lens star.
Description
Anterior chamber depth, lens, axial length, keratometry readings and age of the patients.
Time Frame
Immediately before phacoemulsification surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients that will undergone phacoemulsification for their mild to moderate senile cataracts.
Exclusion Criteria:
congenital and developmental cataract.
cases with congenital lens anomalies as ectopia lentis and spheophakia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
01222328766
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marwa Abdelshafy, MD
Phone
01222328766
Email
drmarwatabl2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marwa A Abdelshafy, MD
Organizational Affiliation
Benha University
Official's Role
Study Director
Facility Information:
Facility Name
Ahmed Abdelshafy
City
Banhā
State/Province
QA
ZIP/Postal Code
13511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy
Phone
01222328766
Email
ahmad4lg@gmail.com
Ext
Abdelshafy
Email
ahmad4lg@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelshafy, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Correlations Between Lens Star and Phacoemulsification.
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