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Changes in Vitreous Temperature During Phacoemulsification

This study is currently recruiting participants.
Verified March 2012 by Asociación para Evitar la Ceguera en México
Sponsor:
Information provided by (Responsible Party):
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT01568242
First received: February 23, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  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: Open Label
Primary Purpose: Basic Science
Official Title: Changes in Vitreous Temperature During Phacoemulsification

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier: NCT01568242     History of Changes
Other Study ID Numbers: APEC-VitTemp
Study First Received: February 23, 2012
Last Updated: March 29, 2012
Health Authority: Mexico: Federal Commission for Sanitary Risks Protection

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

ClinicalTrials.gov processed this record on June 13, 2013