Laser Therapy, Low-LevelPhase 4NCT01033968
Pain Perception at Laser Treatment
A Phase 4 study testing retina photocoagulation in people with Laser Therapy, Low-Level, run by University of Campinas, Brazil.
Trial summary
The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laser Therapy, Low-Level
- What is being tested?
- retina photocoagulation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to May 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease
Who cannot join
- severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.
About this study
Official title: Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths
The purpose of this study is to compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.
Read the detailed description
Purpose: To compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.
Methods: Thirty patients (60 eyes) were enrolled in the study. Each patient had one eye treated with infrared laser (diode, 810nm) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm). The laser treatment was performed following a standardized protocol. Immediately after photocoagulation, the patient was asked to grading pain perception according an 11-point (i.e. 0-10) numerical rating scale (NRS) 2,3, accompanied by the instructions "Please rate your pain by indicating the number that best describes it". This NRS is represented as a straight line (10 cm in length). The numbers between 0 and 10 are spaced at regular intervals along the line, at either end of the line are two poles that are defined as the extreme limits of the response to be measure, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'.
- Conditions
- Laser Therapy, Low-Level
- Being tested
- retina photocoagulation
- Keywords
- lasers, pain measurement, photocoagulation, retina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retina photocoagulationProcedure or surgery
Each patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength
What is being measured
The primary outcome is the main question the study is designed to answer.
Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laser Therapy, Low-LevelStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033968
- Sponsor's protocol ID
- Lira-001
- Status last verified
- May 2010
- First submitted
- 16 Dec 2009
- Last updated
- 20 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lira RP, Nascimento MA, Arieta CE, de Carvalho KM, Silva VB. Pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Am J Ophthalmol. 2010 Nov;150(5):726-730.e1. doi: 10.1016/j.ajo.2010.05.027. Epub 2010 Aug 5.
PubMed 20691418
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Perception at Laser Treatment of Peripheral Retinal Degenerations With Green and Infrared Wavelengths
- ClinicalTrials.gov ID
- NCT01033968
- Acronym / sponsor ID
- Lira-001
- Conditions
- Laser Therapy, Low-Level
- Keywords
- lasers, pain measurement, photocoagulation, retina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Dec 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 pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.
Detailed description
Purpose: To compare the pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths.
Methods: Thirty patients (60 eyes) were enrolled in the study. Each patient had one eye treated with infrared laser (diode, 810nm) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm). The laser treatment was performed following a standardized protocol. Immediately after photocoagulation, the patient was asked to grading pain perception according an 11-point (i.e. 0-10) numerical rating scale (NRS) 2,3, accompanied by the instructions "Please rate your pain by indicating the number that best describes it". This NRS is represented as a straight line (10 cm in length). The numbers between 0 and 10 are spaced at regular intervals along the line, at either end of the line are two poles that are defined as the extreme limits of the response to be measure, with '0' meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine'.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- horseshoe tears and dialyses, besides operculated holes and lattice degeneration in symptomatic patients (photopsias) or with history of retinal disease
Key exclusion criteria (1 listed)
- severe liver disease, pregnancy, patients on regular analgesics, previous laser photocoagulation, and age less than 18 years old.
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 |
|---|---|---|
| retina photocoagulationEach patient had one eye treated with infrared laser (diode, 810nm wavelength) and the other eye treated with green laser (frequency-doubled solid state laser, diode-pumped, with 532-nm wavelength | Procedure or surgery | – |
Primary outcome
Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.
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 20 May 2010.
- Derived from this study: PubMed 20691418Lira RP, Nascimento MA, Arieta CE, de Carvalho KM, Silva VB. Pain perception at laser treatment of peripheral retinal degenerations with green and infrared wavelengths. Am J Ophthalmol. 2010 Nov;150(5):726-730.e1. doi: 10.1016/j.ajo.2010.05.027. Epub 2010 Aug 5.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing retina photocoagulation in people with Laser Therapy, Low-Level, run by University of Campinas, Brazil.
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 1 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 20 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Although the treatment of peripheral retinal degenerations with infrared laser to be well tolerated by the majority of the patients, it is more painful than with green wavelength.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01033968, which also lists 1 linked publication.
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 20 May 2010.