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NCT01568242 Clinical Trial

Changes in Vitreous Temperature During Phacoemulsification

Proliferative Diabetic Retinopathy Clinical Trial

Official title:
Changes in Vitreous Temperature During Phacoemulsification

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01568242
Other study ID # APEC-VitTemp
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date May 2012

Study information
Verified date May 2024
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients from the Retina department that underwent phacoemulsification and vitrectomy Exclusion Criteria: - Posterior capsule rupture

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Phacoemlsification
Transurgical measurement of temperature

Locations
Country Name City State
Mexico Asociación Para Evitar la Ceguera en México Mexico City DF

Sponsors (1)
Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). Every five minutes during a phacoemulsification procedure, and at every step of the surgery
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