Retinal DetachmentNCT01604616
Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears
An observational study of Retinal Detachment, run by Ziv Hospital at 1 site in Israel.
Trial summary
The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Detachment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 1998to Jun 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: man and women above the age of 18 years
Who may be able to join
- above 18 years of age
- retinal tear at least of 3 clock hours.
Who cannot join
- less than 18 years of age
- Retinal tear less than 3 hours
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Ziv Medical Center
Safed
Joseph Pikkel, M.D, pikel.y@ziv.health.gov.il
Otzem Chassid, M.D, otzem.c@ziv.health.gov.il
About this study
The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears.
Read the detailed description
a retrospective study wich compared 2 groups that had giant tear repair in one group, PFCL was left for few days as an intermediate measure until silicone oil or SF6 gas was used to reattach the retina ,and in the control group SF6 or Silicone oil were used, with no PFCL.
- Conditions
- Retinal Detachment
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PCFL GROUP | patients in this group had the PFCL for a period of 7-10 days before it was replaced by SF6 gas or silicone oil | |
| control group | in thos group no PFCL was left in the eye and either SF6 or silicone oil was the definitive treatment at the time of the retinal detachment surgery repair. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJan 1998
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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-control
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Joseph pikkel, M.D, Principal investigator, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604616
- Sponsor's protocol ID
- 0032-12-ZIV
- Status last verified
- May 2012
- First submitted
- 21 May 2012
- Last updated
- 23 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears
- ClinicalTrials.gov ID
- NCT01604616
- Acronym / sponsor ID
- 0032-12-ZIV
- Conditions
- Retinal Detachment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Jan 1998
- Study completion
- Jun 2012 (estimated)
- First posted
- 23 May 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.
The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears.
Detailed description
a retrospective study wich compared 2 groups that had giant tear repair in one group, PFCL was left for few days as an intermediate measure until silicone oil or SF6 gas was used to reattach the retina ,and in the control group SF6 or Silicone oil were used, with no PFCL.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCFL GROUP | – | –patients in this group had the PFCL for a period of 7-10 days before it was replaced by SF6 gas or silicone oil |
| control group | – | –in thos group no PFCL was left in the eye and either SF6 or silicone oil was the definitive treatment at the time of the retinal detachment surgery repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- man and women above the age of 18 years
Key inclusion criteria (2 listed)
- above 18 years of age
- retinal tear at least of 3 clock hours.
Key exclusion criteria (2 listed)
- less than 18 years of age
- Retinal tear less than 3 hours
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2012.
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Intraoperative OCT Guidance of Intraocular Surgery II
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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.
Joseph pikkel, M.D principal investigator
Ziv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Detachment, run by Ziv Hospital at 1 site 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 2 inclusion and 2 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 23 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 23 May 2012; AzTrials last refreshed its copy on 31 Oct 2026.