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Changes in Vitreous Temperature During Phacoemulsification

Sponsor
Asociación para Evitar la Ceguera en México (Other)
Overall Status
Unknown status
CT.gov ID
NCT01568242
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
29
Duration (Days)
15.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Phacoemlsification
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Changes in Vitreous Temperature During Phacoemulsification
Study Start Date :
Feb 1, 2012
Anticipated Primary Completion Date :
Mar 1, 2012
Anticipated Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thermoprobe

Determination of vitreous temperature with a thermoprobe

Device: Phacoemlsification
Transurgical measurement of temperature
Other Names:
  • Thermoprobe

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vitreous temperature [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients from the Retina department that underwent phacoemulsification and vitrectomy
    Exclusion Criteria:
    • Posterior capsule rupture

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asociación Para Evitar la Ceguera en México Mexico City DF Mexico 04030

    Sponsors and Collaborators

    • Asociación para Evitar la Ceguera en México

    Investigators

    • Study Chair: Hugo Quiroz-Mercado, MD, Asociación para Evitar la Ceguera en México

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Asociación para Evitar la Ceguera en México
    ClinicalTrials.gov Identifier:
    NCT01568242
    Other Study ID Numbers:
    • APEC-VitTemp
    First Posted:
    Apr 2, 2012
    Last Update Posted:
    Apr 2, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by Asociación para Evitar la Ceguera en México
    Cataract
    Phacoemulsification
    Temperature
    Vitreous
    Additional relevant MeSH terms:
    Diabetic Retinopathy

    Study Results

    No Results Posted as of Apr 2, 2012