Rhegmatogenous Retinal DetachmentNCT01647373
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling
An observational study of Rhegmatogenous Retinal Detachment, run by Meir Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rhegmatogenous Retinal Detachment
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2013to Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Meir hospital, dept. Of ophthalmology
Kfar Saba
Retina Service, Meir Hospital
Kfar Saba
About this study
Official title: 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.
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- retinal detachment, scleral buckle, silicone sponge, axial length, surgery included silicone sponge scleral buckling, retina currently attached, at least 6 months after surgery
- Medical subject headings
- Retinal Detachment
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length in eye as measured by Zeiss IOL Master.
Measured: Single non-invasive measurement at 1 time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Rubowitz, MD, Principal investigator, Retina Service, Meir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647373
- Sponsor's protocol ID
- 0125-12
- Status last verified
- Jul 2012
- First submitted
- 19 Jul 2012
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.
- ClinicalTrials.gov ID
- NCT01647373
- Acronym / sponsor ID
- 0125-12
- Conditions
- Rhegmatogenous Retinal Detachment
- Keywords
- retinal detachment, scleral buckle, silicone sponge, axial length, surgery included silicone sponge scleral buckling, retina currently attached, at least 6 months after surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Axial length in eye as measured by Zeiss IOL Master.
Time frame: Single non-invasive measurement at 1 time point.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Rubowitz, MD principal investigator
Retina Service, Meir Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhegmatogenous Retinal Detachment, run by Meir Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rubowitz, MD (972-9-7472772, arubowi@smile.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length in eye as measured by Zeiss IOL Master. (time frame: Single non-invasive measurement at 1 time point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.