Correlations Between Lens Star and Phacoemulsification. | NCT05290896

Studies
Correlations Between Lens Star and Phacoemulsification.

NCT05290896

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Mar 22, 2022Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Cataract
Lens Diseases
Lens Opacities

Interventions

Phacoemulsification

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2022Actual

Primary Completion Date

Aug 30, 2022Estimated

Completion Date

Sep 15, 2022Estimated

First Submitted Date

Mar 12, 2022

First Submission Date that Met QC Criteria

Mar 12, 2022

First Posted Date

Mar 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2022

Last Update Posted Date

Mar 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lens star biometry	Other	Biometry done prior to phacoemulsification	Device: Phacoemulsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phacoemulsification	Device	Phacoemulsification for senile cataract.	Lens star biometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between parameters measured by lens star.	Anterior chamber depth, lens, axial length, keratometry readings and age of the patients.	Immediately before phacoemulsification surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Abdelshafy, MD	Contact	01222328766		ahmad4lg@gmail.com
Marwa Abdelshafy, MD	Contact	01222328766		drmarwatabl2012@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed A Abdelshafy, MD	Benha University	Principal Investigator
Marwa A Abdelshafy, MD	Benha University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abdelshafy	Recruiting	Banhā	QA	13511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D007905	Lens Diseases

Ancestor Terms

ID	Term
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018918	Phacoemulsification

Ancestor Terms

ID	Term
D002387	Cataract Extraction
D054140	Refractive Surgical Procedures
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided