Astigmatic Changes Secondary to Eyelid Surgeries | NCT01968174

Studies
Astigmatic Changes Secondary to Eyelid Surgeries

NCT01968174

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Aug 12, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Blepharoptosis

Interventions

Not provided

Countries

Israel

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

Aug 2014

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

Jun 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Oct 19, 2013

First Submission Date that Met QC Criteria

Oct 22, 2013

First Posted Date

Oct 23, 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

Aug 11, 2014

Last Update Posted Date

Aug 12, 2014Estimated

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

Eyelid surgeries change the lid position over the cornea. Previous surgeries evaluated astigmatic corneal changes in children undergoing ptosis repair. Only several studies evaluated astigmatic changes following eyelid surgeries in elderly patients. The investigators aim is to estimate this change, implications on corneal astigmatism may have great effect to future cataract surgeries for this group of patients.

Detailed Description

Patients registered for a lid surgery due to blepharoptosis or ptosis will undergo a topographic examination prior to and 3 months post operative in addition to their regular pre and post operative examination astigmatic shift will be mathematically measured.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
eyelid displacement		patients suffering from eyelid disposition due to ptosis, blepharochalasis and are registered for eyelid surgeries will be assigned for the study

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
astigmatic corneal decrease following eyelid surgery	eyelid change in position will change the effect on corneal astigmatism measured 3 months post surgery	3 months

Secondary Outcomes

Measure	Description	Time Frame
type of astigmatism	a change from against the rule astigmatism to with the rule astigmatism following eyelid surgery will be evaluated	3 months

Other Outcomes

Measure	Description	Time Frame
complications	complications following eyelid surgery and their implications on astigmatism	3 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

upper lid blepharochalasis

Exclusion Criteria:

prior eyelid trauma mental retardation or other causes preventing from signing an agreement form

Accepts Healthy Volunteers

Yes

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

patients undergoing eyelid surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ARIK NEMET, DR	Contact	+972-9747-2154		arik.nemet@gmail.com
SHAY OFIR, DR	Contact	+972-9747-2154		shayofir1@gmail.com

Overall Officials

Name	Affiliation	Role
Arye - Nemet, MD	Meir Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical center	Recruiting	Kfar Saba	Israel		Israel

Condition Browse Module

MeSH Terms

ID	Term
D001763	Blepharoptosis
D001251	Astigmatism

Ancestor Terms

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases
D012030	Refractive Errors

Browse Leaves

Not provided

Browse Branches

Not provided