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Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

This study is not yet open for participant recruitment.
Verified July 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Alexander Rubowitz, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01647373
First received: July 19, 2012
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  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.

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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01647373

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

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

No publications provided

Responsible Party: Alexander Rubowitz, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01647373     History of Changes
Other Study ID Numbers: 0125-12
Study First Received: July 19, 2012
Last Updated: July 20, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013