- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01568242
Changes in Vitreous Temperature During Phacoemulsification
March 29, 2012 updated by: Asociación para Evitar la Ceguera en México
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guillermo Salcedo-Villanueva, MD
- Phone Number: 1172 (52) 55 10841400
- Email: salcedovilla@gmail.com
Study Locations
-
-
DF
-
Mexico City, DF, Mexico, 04030
- Recruiting
- Asociación Para Evitar la Ceguera en México
-
Contact:
- Yoko Burgoa
- Phone Number: 1172 (52) 55 10841400
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients from the Retina department that underwent phacoemulsification and vitrectomy
Exclusion Criteria:
- Posterior capsule rupture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Thermoprobe
Determination of vitreous temperature with a thermoprobe
|
Transurgical measurement of temperature
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Every five minutes during a phacoemulsification procedure, and at every step of the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hugo Quiroz-Mercado, MD, Asociación Para Evitar la Ceguera en México
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Anticipated)
March 1, 2012
Study Completion (Anticipated)
March 1, 2012
Study Registration Dates
First Submitted
February 23, 2012
First Submitted That Met QC Criteria
March 29, 2012
First Posted (Estimate)
April 2, 2012
Study Record Updates
Last Update Posted (Estimate)
April 2, 2012
Last Update Submitted That Met QC Criteria
March 29, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APEC-VitTemp
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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