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Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2012 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01647373
First Posted: July 23, 2012
Last Update Posted: June 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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
Rhegmatogenous Retinal Detachment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

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

Estimated Enrollment: 50
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
  Eligibility

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 Submitted: July 19, 2012
First Posted: July 23, 2012
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