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
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Sponsor:
Meir Medical Center
Information provided by (Responsible Party):
Meir Medical Center
Tracking Information | ||||
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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 |
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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Senior) | |||
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 |
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PRS Account | Meir Medical Center | |||
Verification Date | July 2012 |