Eyes With Narrow AnglePhase 4NCT00426400
Anti-Aggregative Therapy and Laser Iridectomy
A Phase 4 study testing The cessation of anti-aggregative treatment for 10 days in people with Eyes With Narrow Angle, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Eyes With Narrow Angle
- What is being tested?
- The cessation of anti-aggregative treatment for 10 days
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Mar 2006to not given
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with narrow angle that need laser iridectomy and take anti- aggregative treatment
- over 20 years old
- patients who can stop their anti-aggregative treatment for 10 days
Who cannot join
- under coumadin treatment
- post ocular surgeries
Trial locations and contacts
1 site in 1 country.
Hani Levkovitch-Verbin, MD contact
Israel1 site, 1 recruiting
- Recruiting
Goldschleger Eye Institute
Tel HaShomer
Hani Levkovitch-Verbin, MD, halevko@hotmail.com
Hani Levkovitch-Verbin, MD
About this study
Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other eye after discontinuing the anti-aggregative treatment. The patients will be followed-up for 3 months.
- Conditions
- Eyes With Narrow Angle
- Being tested
- The cessation of anti-aggregative treatment for 10 days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cessation of anti-aggregative treatment for 10 daysDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eyes With Narrow AngleStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Hani Levkovitch-Verbin, MD, Principal investigator, Goldscheleger Eye Institute, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426400
- Sponsor's protocol ID
- SHEBA-05-3876-HLV-CTIL
- Status last verified
- Jan 2007
- First submitted
- 25 Oct 2006
- Last updated
- 24 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Aggregative Therapy and Laser Iridectomy
- ClinicalTrials.gov ID
- NCT00426400
- Acronym / sponsor ID
- SHEBA-05-3876-HLV-CTIL
- Conditions
- Eyes With Narrow Angle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2006
- First posted
- 24 Jan 2007 (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.
Our study investigates the effect of anti-aggregative treatment on success and complications of laser iridectomy. The study includes patients scheduled for laser iridectomy due to narrow angles.Patients will undergo first laser treatment with the anti-aggregative treatment and will scheduled for next lase in the other eye after discontinuing the anti-aggregative treatment. The patients will be followed-up for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with narrow angle that need laser iridectomy and take anti- aggregative treatment
- over 20 years old
- patients who can stop their anti-aggregative treatment for 10 days
Key exclusion criteria (2 listed)
- under coumadin treatment
- post ocular surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The cessation of anti-aggregative treatment for 10 days | Drug | – |
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 24 Jan 2007.
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.
Hani Levkovitch-Verbin, MD contact
Hani Levkovitch-Verbin, MD principal investigator
Goldscheleger Eye Institute, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The cessation of anti-aggregative treatment for 10 days in people with Eyes With Narrow Angle, run by Sheba Medical Center 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 3 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 24 Jan 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hani Levkovitch-Verbin, MD (Hani.Verbin@ sheba.health.gov.il), or a site near the patient. 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 24 Jan 2007.