Bruch RuptureNCT00803153
PASCAL: Safety and Complications, Experience After 1301 Consecutive Cases
An observational study of Bruch Rupture and Choroidal Detachment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To report the safety and incidence of adverse effects, during and after a successful photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its modified settings Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Bruch Rupture, Choroidal Detachment
- What is being tested?
- Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2008to Dec 2008
- Phase
- Observational
- 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 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients which has been treated with the pattern scan laser system between november 2007 to july 2008.
Who may be able to join
- Patients treated with PASCAL system
Who cannot join
- Uncompleted file.
- Loss of follow-up.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
Official title: Pattern Scan Laser Photocoagulation: Safety and Complications, Experience After 1301 Consecutive Cases.
To report the safety and incidence of adverse effects, during and after a successful photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its modified settings
- Conditions
- Bruch Rupture, Choroidal Detachment
- Being tested
- Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]
- Keywords
- Panretinal photocoagulation, Bruch rupture, Choroidal detachment, complication rates
- Medical subject headings
- Choroidal Effusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system]Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rates
Measured: during treatment and follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2008
- Study completionDec 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 Bruch RuptureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803153
- Sponsor's protocol ID
- APEC-038
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
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
- Pattern Scan Laser Photocoagulation: Safety and Complications, Experience After 1301 Consecutive Cases.
- ClinicalTrials.gov ID
- NCT00803153
- Acronym / sponsor ID
- APEC-038
- Conditions
- Bruch Rupture, Choroidal Detachment
- Keywords
- Panretinal photocoagulation, Bruch rupture, Choroidal detachment, complication rates
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: undefined
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Dec 2008 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 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.
To report the safety and incidence of adverse effects, during and after a successful photocoagulation for different pathologies using a Pattern Scan Laser (PASCAL) system and its modified settings
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients which has been treated with the pattern scan laser system between november 2007 to july 2008.
Key inclusion criteria (1 listed)
- Patients treated with PASCAL system
Key exclusion criteria (2 listed)
- Uncompleted file.
- Loss of follow-up.
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 |
|---|---|---|
| Panretinal Photocoagulation [Pattern Scan Laser (PASCAL) system] | Procedure or surgery | – |
Primary outcome
Complication rates
Time frame: during treatment and follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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?
An observational study of Bruch Rupture and Choroidal Detachment, 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 1 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: withdrawn, 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complication rates (time frame: during treatment and follow-up). 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.