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Changes in Vitreous Temperature During Phacoemulsification

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01568242
First Posted: April 2, 2012
Last Update Posted: April 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Asociación para Evitar la Ceguera en México
  Purpose
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.

Condition Intervention
Proliferative Diabetic Retinopathy Device: Phacoemlsification

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Changes in Vitreous Temperature During Phacoemulsification

Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 15
Study Start Date: February 2012
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thermoprobe
Determination of vitreous temperature with a thermoprobe
Device: Phacoemlsification
Transurgical measurement of temperature
Other Name: Thermoprobe

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients from the Retina department that underwent phacoemulsification and vitrectomy

Exclusion Criteria:

  • Posterior capsule rupture
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01568242


Contacts
Contact: Guillermo Salcedo-Villanueva, MD (52) 55 10841400 ext 1172 salcedovilla@gmail.com

Locations
Mexico
Asociación Para Evitar la Ceguera en México Recruiting
Mexico City, DF, Mexico, 04030
Contact: Yoko Burgoa    (52) 55 10841400 ext 1172      
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Study Chair: Hugo Quiroz-Mercado, MD APEC
  More Information

Responsible Party: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT01568242     History of Changes
Other Study ID Numbers: APEC-VitTemp
First Submitted: February 23, 2012
First Posted: April 2, 2012
Last Update Posted: April 2, 2012
Last Verified: March 2012

Keywords provided by Asociación para Evitar la Ceguera en México:
Cataract
Phacoemulsification
Temperature
Vitreous

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases