Proliferative Diabetic RetinopathyPhase 4NCT00802269
Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
A Phase 4 study testing Retinal laser photocoagulation in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Retinal laser photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2008to Nov 2008
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older, that signed informed consent
- Proliferative diabetic retinopathy with indication for panretinal photocoagulation
Who cannot join
- Previous retinal photocoagulation
- Previous ocular surgical procedures
- Ocular media opacities
- History of trigeminal neuralgia
- Chronic ocular pain
- Depression under conductual or medical treatment
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociacion para Evitar la Ceguera en Mexico
Mexico City, Mexico City, 04030
About this study
The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Retinal laser photocoagulation
- Keywords
- Proliferative diabetic retinopathy, Laser photocoagulation, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retinal laser photocoagulationProcedure or surgery
Also called Alcon Eyelite 532 (doubled frequency Nd:Yag)
Retinal laser photocoagulation using a 532 nm laser
| Study group | Role | What they receive |
|---|---|---|
| Reduced Fluence Parameters | Experimental | Eyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW) Receives: Procedure: Retinal laser photocoagulation |
| Traditional parameters | Active comparator | Eyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW) Receives: Procedure: Retinal laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (NRS-11 scale)
Measured: Immediately post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar Alvarez-Verduzco, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802269
- Sponsor's protocol ID
- APEC-032
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Using Reduced Fluence Parameters in Photocoagulation for Diabetic Retinopathy.
- ClinicalTrials.gov ID
- NCT00802269
- Acronym / sponsor ID
- APEC-032
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative diabetic retinopathy, Laser photocoagulation, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 4 Dec 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.
The used of reduced fluence parameters for panretinal photocoagulation decreases pain as perceived by the patient, compared to traditional parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Fluence Parameters | Experimental | Procedure: Retinal laser photocoagulationEyes receiving retinal photocoagulation with reduced fluence parameters (time 20-50 msec, power 400-700 mW) |
| Traditional parameters | Active comparator | Procedure: Retinal laser photocoagulationEyes receiving retinal photocoagulation with traditional parameters (time 100-200 msec, power 200-400 mW) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older, that signed informed consent
- Proliferative diabetic retinopathy with indication for panretinal photocoagulation
Key exclusion criteria (6 listed)
- Previous retinal photocoagulation
- Previous ocular surgical procedures
- Ocular media opacities
- History of trigeminal neuralgia
- Chronic ocular pain
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 |
|---|---|---|
| Retinal laser photocoagulationAlso: Alcon Eyelite 532 (doubled frequency Nd:Yag)Retinal laser photocoagulation using a 532 nm laser | Procedure or surgery | Reduced Fluence Parameters, Traditional parameters |
Primary outcome
Pain (NRS-11 scale)
Time frame: Immediately post-treatment
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Oscar Alvarez-Verduzco, MD principal investigator
Asociación para Evitar la Ceguera en México
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 Retinal laser photocoagulation in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 2 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: stopped early, as of the sponsor's last update on 30 May 2024. 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 Mexico. 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 was stopped early (reason given: Undefined). Results are not available in the source record.
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?
Pain (NRS-11 scale) (time frame: Immediately post-treatment). 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 30 May 2024.