CataractPhase 4NCT01019018
Efficacy of Subtenon's Block With Olive Tipped Cannula
A Phase 4 study testing subtenon block in people with Cataract, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- subtenon block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Nov 2009to Oct 2011
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing cataract extraction procedure under local anesthesia
Who cannot join
- Patients allergic to local anesthetic solutions.
- Presence local sepsis,
- Previous retinal or strabismus surgery in the same eye.
- Orbital abnormalities
- Previous subtenon's block in the same quadrant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial
The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.
- Conditions
- Cataract
- Being tested
- subtenon block
- Keywords
- subtenon block
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtenon blockDevice
subtenon block with stevens cannula
subtenon blockDevice
subtenon block with Olive tip cannula cannula
| Study group | Role | What they receive |
|---|---|---|
| Stevens cannula | Active comparator | Subtenon with stevens cannula Receives: Device: subtenon block |
| Olive tip | Experimental | Olive tip group Receives: Device: subtenon block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Akinesia score
Measured: 10 minutes after the block
Secondary outcomes (1)
Surgeon satisfactions score
Measured: At the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019018
- Sponsor's protocol ID
- RP 0928
- Status last verified
- Nov 2009
- First submitted
- 17 Nov 2009
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01019018
- Acronym / sponsor ID
- RP 0928
- Conditions
- Cataract
- Keywords
- subtenon block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Nov 2009 (actual)
- Primary completion
- Apr 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Nov 2009 (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 this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stevens cannula | Active comparator | Device: subtenon blockSubtenon with stevens cannula |
| Olive tip | Experimental | Device: subtenon blockOlive tip group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient undergoing cataract extraction procedure under local anesthesia
Key exclusion criteria (5 listed)
- Patients allergic to local anesthetic solutions.
- Presence local sepsis,
- Previous retinal or strabismus surgery in the same eye.
- Orbital abnormalities
- Previous subtenon's block in the same quadrant.
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 |
|---|---|---|
| subtenon blocksubtenon block with stevens cannula | Device | Stevens cannula |
| subtenon blocksubtenon block with Olive tip cannula cannula | Device | Olive tip |
Primary outcome
Measurement of Akinesia score
Time frame: 10 minutes after the block
1 secondary outcome
Surgeon satisfactions score
Time frame: At the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 subtenon block in people with Cataract, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2021. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Akinesia score (time frame: 10 minutes after the block). 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 21 Oct 2021.