PainNCT01477996
Pain After Intravitreal Therapy
A study testing 27-gauge and 30-gauge in people with Pain, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
Trial summary
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT. Read more about this study
- Who is it for?
- Ages 51 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- 27-gauge and 30-gauge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Dec 2011
- 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 51 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vitrearetinal disease including age-related macular degeneration,
- clinical significant macular edema due to diabetic retinopathy or other vascular disorders
- treatment with intravitreal therapy
Who cannot join
- missing informed consent
- age under 50 years
Trial locations and contacts
1 site in 1 country.
Austria1 site
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology; Rudolf Foundation Clinic, Juchgasse 25
Vienna, 1030
About this study
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.
Read the detailed description
Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).
Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.
Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.
- Conditions
- Pain
- Being tested
- 27-gauge, 30-gauge
- Keywords
- intravitreal therapy, pain scales, gauge, Pain Scores, Visual Analog Scale
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
27-gaugeProcedure or surgery
27-gauge needle for IVT
30-gaugeProcedure or surgery
30-gauge needle for IVT
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 27-gauge needle Receives: Procedure: 27-gauge |
| Group 2 | Active comparator | 30-gauge needle Receives: Procedure: 30-gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoge Scale
pain scores on the visual analog scale after the IVT
Measured: 1 day, after the intravitreal therapy (IVT)
Secondary outcomes (2)
patients demographic data
age, gender, number of IVT, surgeon, prior surgical procedures
Measured: 1 day, record of patients data before or after intravitreal therapy (IVT)
Baker scale
pain scores on the baker scale after the IVT
Measured: 1 day, after the intravitreal therapy (IVT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christiane I. Falkner-Radler, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Investigators
- Christiane I Falkner-Radler, MD, Principal investigator, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgerySusanne Binder, MD, Study chair, The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477996
- Sponsor's protocol ID
- FR-7-CI-2011
- Status last verified
- Nov 2011
- First submitted
- 8 Aug 2011
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Intravitreal Therapy
- ClinicalTrials.gov ID
- NCT01477996
- Acronym / sponsor ID
- FR-7-CI-2011
- Conditions
- Pain
- Keywords
- intravitreal therapy, pain scales, gauge, Pain Scores, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser SurgeryUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 Nov 2011 (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.
This randomized clinical trial is comparing two different needles (27 gauge versus 30 gauge) for intravitreal therapy (IVT). Standardized questionnaires and pain scales should allow for standard recommendation regarding the optimal needle size for IVT.
Detailed description
Purpose: To evaluate the influence of the type of the needle on pain scores after intravitreal therapy (IVT).
Design: Randomized clinical trial Methods: A total of 200 patients, treated with an IVT for exudative age-related macular degeneration (AMD) or a vascular retinal disease, will be included and randomly assigned to be treated with either a 27-gauge needle (group 1) or a 30-gauge needle (group 2). After IVt the patient has to fill out a standardized questionnaire including pain scores on the visual analog scale after the surgical procedure.
Regression analysis of the scaled questionnaires should allow for a standard recommendation regarding the optimal needle size for minimal subjective pain during IVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: 27-gauge27-gauge needle |
| Group 2 | Active comparator | Procedure: 30-gauge30-gauge needle |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- vitrearetinal disease including age-related macular degeneration,
- clinical significant macular edema due to diabetic retinopathy or other vascular disorders
- treatment with intravitreal therapy
Key exclusion criteria (2 listed)
- missing informed consent
- age under 50 years
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 |
|---|---|---|
| 27-gauge27-gauge needle for IVT | Procedure or surgery | Group 1 |
| 30-gauge30-gauge needle for IVT | Procedure or surgery | Group 2 |
Primary outcome
Visual Analoge Scale
Time frame: 1 day, after the intravitreal therapy (IVT)
pain scores on the visual analog scale after the IVT
2 secondary outcomes
patients demographic data
Time frame: 1 day, record of patients data before or after intravitreal therapy (IVT)
Baker scale
Time frame: 1 day, after the intravitreal therapy (IVT)
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 26 Jan 2016.
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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.
Christiane I Falkner-Radler, MD principal investigator
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Susanne Binder, MD study chair
The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 27-gauge and 30-gauge in people with Pain, run by The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery at 1 site in Austria.
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: finished, as of the sponsor's last update on 26 Jan 2016. 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 Austria. 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?
Visual Analoge Scale (time frame: 1 day, after the intravitreal therapy (IVT)). 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 26 Jan 2016.