- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01647373
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling
June 11, 2013 updated by: Meir Medical Center
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Rubowitz, MD
- Phone Number: 972-9-7472772
- Email: arubowi@smile.net.il
Study Locations
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Kfar Saba, Israel
- Meir hospital, dept. Of ophthalmology
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Kfar Saba, Israel
- Retina Service, Meir Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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 .
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Axial length in eye as measured by Zeiss IOL Master.
Time Frame: Single non-invasive measurement at 1 time point.
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Single non-invasive measurement at 1 time point.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alex Rubowitz, MD, Retina Service, Meir Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (ANTICIPATED)
July 1, 2014
Study Completion (ANTICIPATED)
July 1, 2014
Study Registration Dates
First Submitted
July 19, 2012
First Submitted That Met QC Criteria
July 20, 2012
First Posted (ESTIMATE)
July 23, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
June 12, 2013
Last Update Submitted That Met QC Criteria
June 11, 2013
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0125-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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