Comparison of Intraocular Lens Power Calculation Methods... | NCT01979172

Studies
Comparison of Intraocular Lens Power Calculation Methods After Corneal Laser Refractive Surgery in Axial and Refractive Ammertropia

NCT01979172

Sponsor

The National Eye Hospital, Cairo, Egypt

Status

Unknown status

Last Update Posted

Nov 8, 2013Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Cataract
Refractive Errors

Interventions

Not provided

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

Nov 2013

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

Nov 2013

Primary Completion Date

Mar 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Nov 3, 2013

First Submission Date that Met QC Criteria

Nov 3, 2013

First Posted Date

Nov 8, 2013Estimated

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

Nov 3, 2013

Last Update Posted Date

Nov 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed El Bahrawy, Dr., The National Eye Hospital, Cairo, EgyptPrincipal Investigator

Lead Sponsor

The National Eye Hospital, Cairo, EgyptOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study aims at determining the best biometry calculation formula to be used in IOL calculation of cataract patients how previously underwent laser refractive correction surgery

Detailed Description

Patients undergoing laser refractive surgery will will be investigated in means of Pentacam testing and IOL master biometry both preoperative and 6 weeks postoperative to determine which IOL calculation formula is the nearest and most accurate to preoperative records in different refractive sittings.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Measure	Description	Time Frame
Best Selected IOL calculation formula		6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patient undergoing laser refractive surgery

Exclusion Criteria:

previous ophthalmic surgery
previous trauma
ocular pathology other than refractive error

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patient undergoing laser refractive surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed O El Bahrawy, MS	Contact	+201224609383		bahrawy.mohamed@gmail.com

Overall Officials

Name	Affiliation	Role
Rami R Fikry, MD/FRCS	Watany Eye Hospital	Principal Investigator
Ahmed Assaf, MD/FRCS	Watany Eye Hospital	Study Director
Ahmed Osama, MS

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Watany Eye Hopsital	Recruiting	Cairo	Cairo Governorate		Egypt

Label	URL
Watany Eye Hospital Official website	View source

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D012030	Refractive Errors

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided