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Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

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ClinicalTrials.gov Identifier: NCT01647373
Recruitment Status : Unknown
Verified July 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 23, 2012
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Rhegmatogenous Retinal Detachment

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.
Study Start Date : July 2013
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Axial length in eye as measured by Zeiss IOL Master. [ Time Frame: Single non-invasive measurement at 1 time point. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647373


Contacts
Contact: Alexander Rubowitz, MD 972-9-7472772 arubowi@smile.net.il

Locations
Israel
Meir hospital, dept. Of ophthalmology Not yet recruiting
Kfar Saba, Israel
Retina Service, Meir Hospital Not yet recruiting
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Alex Rubowitz, MD Retina Service, Meir Hospital
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01647373     History of Changes
Other Study ID Numbers: 0125-12
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: July 2012

Keywords provided by Meir Medical Center:
retinal detachment
scleral buckle
silicone sponge
axial length
surgery included silicone sponge scleral buckling
retina currently attached
at least 6 months after surgery

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases