Axial Length Change in Eyes Treated by Silicone Sponge Sc... | NCT01647373

Studies
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

NCT01647373

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Jun 12, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Rhegmatogenous Retinal Detachment

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

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Jul 19, 2012

First Submission Date that Met QC Criteria

Jul 20, 2012

First Posted Date

Jul 23, 2012Estimated

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

Jun 11, 2013

Last Update Posted Date

Jun 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

All existing medical literatue regarding axial length (AL) changes after scleral buckling surgery for retinal detachment, descibes changes after solid silicone buckling. In this hospital, the investigators use only silicone sponge buckling, which has different properties and a different buckle profile. there are no studies in the literature describing tha AL changes after sponge buckling, or whether the AL change is less or more than with solid silicone buckles. The investigators wish to determine whether the AL change profile with their silicone sponge is significantly different, and if so, whether this is clinically important in determining the better choice of buckle material to be preferred.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Axial length in eye as measured by Zeiss IOL Master.		Single non-invasive measurement at 1 time point.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients at least 6 months after succesful retinal detachment surgery
with silicone sponge scleral buckling
currently attached
with IOL Master pre-surgery Axial Length measurement

Exclusion Criteria:

patients with failed surgery and currently detached
patients with vitreos silicone oil tamponade
patients with radial or other non-circumference buckles
patients with unclear media not amenable to IOL Master exam

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients at least 6 months after succesful retinal detachment surgery, with silicone sponge scleral buckling, currently attached, and with IOL Master pre-surgery Axial Length measurement .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alexander Rubowitz, MD	Contact	972-9-7472772		arubowi@smile.net.il

Overall Officials

Name	Affiliation	Role
Alex Rubowitz, MD	Retina Service, Meir Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir hospital, dept. Of ophthalmology		Kfar Saba			Israel
Retina Service, Meir Hospital

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided