Retinal DisordersNCT00735657
Anesthesia for Pars Plana Vitrectomy (PPV) With Insulin Needle
A study testing needle and Pars Plana Vitrectomy in people with Retinal Disorders, run by King Khaled Eye Specialist Hospital at 1 site in Saudi Arabia.
Trial summary
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Retinal Disorders
- What is being tested?
- needle and Pars Plana Vitrectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Aug 2008to Dec 2010
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing pars plana vitrectomy under local anesthesia
Who cannot join
- Patients allergic to local anesthetic solutions
- With local sepsis
- Serious impairment of coagulation
- Orbital abnormalities
- Unable to cooperate in maintaining a relatively motionless supine position
- Who refused the anesthetic technique
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anesthesia for PPV Using Insulin Needle
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.
Read the detailed description
The author wants to see the effect of short needle in patients undergoing retinal surgery.
- Conditions
- Retinal Disorders
- Being tested
- needle, Pars Plana Vitrectomy
- Keywords
- Efficiency, Pars, Plana, Vitrectomy
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needleDevice
Also called Peribulbar blockade with standard needle
Peribulbar blockade with standard (25 mm) needle
needleDevice
Also called Peribulbar blockade with short needle
Peribulbar blockade with short (12.5 mm) needle
Pars Plana VitrectomyProcedure or surgery
Also called Extraconal block
Peribulbar block
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Control Receives: Device: needle; Procedure: Pars Plana Vitrectomy |
| Group 2 | Active comparator | Block with short needle Receives: Device: needle; Procedure: Pars Plana Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of insulin needle.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DisordersStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khaled Eye Specialist Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Waleed Riad, MD, Principal investigator, KKESH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735657
- Sponsor's protocol ID
- Rp0822
- Status last verified
- Nov 2021
- First submitted
- 1 Jul 2008
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia for PPV Using Insulin Needle
- ClinicalTrials.gov ID
- NCT00735657
- Acronym / sponsor ID
- Rp0822
- Conditions
- Retinal Disorders
- Keywords
- Efficiency, Pars, Plana, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Khaled Eye Specialist HospitalOther government
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 15 Aug 2008 (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.
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.
Detailed description
The author wants to see the effect of short needle in patients undergoing retinal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: needle, Procedure: Pars Plana VitrectomyControl |
| Group 2 | Active comparator | Device: needle, Procedure: Pars Plana VitrectomyBlock with short needle |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing pars plana vitrectomy under local anesthesia
Key exclusion criteria (6 listed)
- Patients allergic to local anesthetic solutions
- With local sepsis
- Serious impairment of coagulation
- Orbital abnormalities
- Unable to cooperate in maintaining a relatively motionless supine position
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 |
|---|---|---|
| needleAlso: Peribulbar blockade with standard needlePeribulbar blockade with standard (25 mm) needle | Device | Group 1 |
| needleAlso: Peribulbar blockade with short needlePeribulbar blockade with short (12.5 mm) needle | Device | Group 2 |
| Pars Plana VitrectomyAlso: Extraconal blockPeribulbar block | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Efficacy of insulin needle.
Time frame: 1 year
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 2 Dec 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.
Waleed Riad, MD principal investigator
KKESH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing needle and Pars Plana Vitrectomy in people with Retinal Disorders, 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 6 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 2 Dec 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.
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?
Efficacy of insulin needle. (time frame: 1 year). 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 2 Dec 2021.