Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

Tracking Information
First Submitted Date	July 19, 2012
First Posted Date	July 23, 2012
Last Update Posted Date	June 12, 2013
Study Start Date	July 2013
Estimated Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: July 20, 2012)	Axial length in eye as measured by Zeiss IOL Master. [ Time Frame: Single non-invasive measurement at 1 time point. ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01647373 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling
Official Title	Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.
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
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
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 .
Condition	Rhegmatogenous Retinal Detachment
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: July 20, 2012)	50
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	July 2014
Estimated Primary Completion Date	July 2014 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 90 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Israel
Removed Location Countries
Administrative Information
NCT Number	NCT01647373
Other Study ID Numbers	0125-12
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Meir Medical Center
Study Sponsor	Meir Medical Center
Collaborators	Not Provided
Investigators	Principal Investigator: Alex Rubowitz, MD Retina Service, Meir Hospital
PRS Account	Meir Medical Center
Verification Date	July 2012