Retinal DetachmentPhase 3NCT00404209
Pressurized PPV 23GA Vitrectomy in Complicated Diabetic Tractional Retinal Detachment
A Phase 3 study testing Vitrectomy in people with Retinal Detachment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2007to Feb 2008
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Complicated retinal detachment with no more than 6months of evolution
Who cannot join
- Retinal detachments of more than 6 months of evolution No light perception
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación para Evitar la Ceguera en México, Hospital "Luis Sánchez Bulnes"
Mexico City, Mexico DF, 04030
About this study
Official title: Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment
To investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.
- Conditions
- Retinal Detachment
- Being tested
- Vitrectomy
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
pressurized 23GA vitrectomy with a 3D system
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfluorocarbon liquids consumption
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2007
- Study completionFeb 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 Retinal DetachmentStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Investigators
- Hugo Quiroz-Mercado, MD, Principal investigator, Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"Raul Velez-Montoya, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00404209
- Sponsor's protocol ID
- APEC-008
- Status last verified
- May 2024
- First submitted
- 30 Jun 2006
- Last updated
- 30 May 2024
- Results posted
- 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
- Pressurized Perfluorocarbon Perfused 23 GA Vitrectomy in Complicated Diabetic Retinal Detachment
- ClinicalTrials.gov ID
- NCT00404209
- Acronym / sponsor ID
- APEC-008
- Conditions
- Retinal Detachment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Mar 2007 (actual)
- Primary completion
- Mar 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 28 Nov 2006 (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 investigate the feasibility and advantages of using pressurized perfluorocarbon liquid (PCL) perfusion to remove vitreous during suction-cutting 23 GA vitrectomy using a dual, dynamic drive (3D)technology, in complicated retinal detachment surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Complicated retinal detachment with no more than 6months of evolution
Key exclusion criteria (1 listed)
- Retinal detachments of more than 6 months of evolution No light perception
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 |
|---|---|---|
| Vitrectomypressurized 23GA vitrectomy with a 3D system | Procedure or surgery | – |
Primary outcome
Perfluorocarbon liquids consumption
Time frame: two months
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.
Hugo Quiroz-Mercado, MD principal investigator
Asociación para Evitar la Ceguera en Mexico, Hospital "Luis Sanchez Bulnes"
Raul Velez-Montoya, 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 3 study testing Vitrectomy in people with Retinal 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 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: 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Perfluorocarbon liquids consumption (time frame: two months). 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.