Proliferative Diabetic RetinopathyNCT01568242
Changes in Vitreous Temperature During Phacoemulsification
A study testing Phacoemlsification in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen during an uneventful phaco surgery. Significant changes occur between the baseline temperature and after every step of the surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Phacoemlsification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2012to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients from the Retina department that underwent phacoemulsification and vitrectomy
Who cannot join
- Posterior capsule rupture
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
Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen during an uneventful phaco surgery. Significant changes occur between the baseline temperature and after every step of the surgery.
Read the detailed description
A 23-gauge thermometer probe inserted prior to the beginning of the cataract surgery to measure the vitreous temperature at different stages of the procedure (capsulorrhexis, hydrodissection, phacomulsification, irrigation/aspiration and intraocular lens (IOL) implantation). Room temperature also registered during every step. At the end of the surgery, oral temperature will be measured.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Phacoemlsification
- Keywords
- Cataract, Phacoemulsification, Temperature, Vitreous
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhacoemlsificationDevice
Also called Thermoprobe
Transurgical measurement of temperature
| Study group | Role | What they receive |
|---|---|---|
| Thermoprobe | Experimental | Determination of vitreous temperature with a thermoprobe Receives: Device: Phacoemlsification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitreous temperature
Temperature of the vitreous is taken every five minutes from the start of a phacoemulsification. Also Temperature is take after every step of the surgery (capsulorhexis, hydrodissection, phacoemulsification, irrigation/aspiration, IOL implantation).
Measured: Every five minutes during a phacoemulsification procedure, and at every step of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionMay 2012
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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- Investigators
- Hugo Quiroz-Mercado, MD, Study chair, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568242
- Sponsor's protocol ID
- APEC-VitTemp
- Status last verified
- May 2024
- First submitted
- 23 Feb 2012
- 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
- Changes in Vitreous Temperature During Phacoemulsification
- ClinicalTrials.gov ID
- NCT01568242
- Acronym / sponsor ID
- APEC-VitTemp
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Cataract, Phacoemulsification, Temperature, Vitreous
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Undefined
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 2 Apr 2012 (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.
Temperature in the vitreous cavity decreases during vitrectomy, and the same effect is seen during an uneventful phaco surgery. Significant changes occur between the baseline temperature and after every step of the surgery.
Detailed description
A 23-gauge thermometer probe inserted prior to the beginning of the cataract surgery to measure the vitreous temperature at different stages of the procedure (capsulorrhexis, hydrodissection, phacomulsification, irrigation/aspiration and intraocular lens (IOL) implantation). Room temperature also registered during every step. At the end of the surgery, oral temperature will be measured.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thermoprobe | Experimental | Device: PhacoemlsificationDetermination of vitreous temperature with a thermoprobe |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from the Retina department that underwent phacoemulsification and vitrectomy
Key exclusion criteria (1 listed)
- Posterior capsule rupture
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 |
|---|---|---|
| PhacoemlsificationAlso: ThermoprobeTransurgical measurement of temperature | Device | Thermoprobe |
Primary outcome
Vitreous temperature
Time frame: Every five minutes during a phacoemulsification procedure, and at every step of the surgery
Temperature of the vitreous is taken every five minutes from the start of a phacoemulsification. Also Temperature is take after every step of the surgery (capsulorhexis, hydrodissection, phacoemulsification, irrigation/aspiration, IOL implantation).
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.
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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 study chair
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 study testing Phacoemlsification 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 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: 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?
Vitreous temperature (time frame: Every five minutes during a phacoemulsification procedure, and at every step of the surgery). 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.