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Changes in Vitreous Temperature During Phacoemulsification

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Unknown status

Phase

Not Applicable

Locations

Mexico

Study Type

Interventional

Intervention

Phacoemlsification

About this trial

This is an interventional basic science trial for Proliferative Diabetic Retinopathy focused on measuring Cataract, Phacoemulsification, Temperature, Vitreous

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients from the Retina department that underwent phacoemulsification and vitrectomy

Exclusion Criteria:

Posterior capsule rupture

Sites / Locations

Asociación Para Evitar la Ceguera en MéxicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Thermoprobe

Arm Description

Determination of vitreous temperature with a thermoprobe

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT01568242

First Posted

February 23, 2012

Last Updated

March 29, 2012

Sponsor

Asociación para Evitar la Ceguera en México

1. Study Identification

Unique Protocol Identification Number

NCT01568242

Brief Title

Changes in Vitreous Temperature During Phacoemulsification

Official Title

Changes in Vitreous Temperature During Phacoemulsification

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2012 (Anticipated)

Study Completion Date

March 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

Keywords

Cataract, Phacoemulsification, Temperature, Vitreous

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Thermoprobe

Arm Type

Experimental

Arm Description

Determination of vitreous temperature with a thermoprobe

Intervention Type

Device

Intervention Name(s)

Phacoemlsification

Other Intervention Name(s)

Thermoprobe

Intervention Description

Transurgical measurement of temperature

Primary Outcome Measure Information:

Title

Vitreous temperature

Description

Time Frame

Every five minutes during a phacoemulsification procedure, and at every step of the surgery

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients from the Retina department that underwent phacoemulsification and vitrectomy Exclusion Criteria: Posterior capsule rupture

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guillermo Salcedo-Villanueva, MD

Phone

(52) 55 10841400

Ext

1172

salcedovilla@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz-Mercado, MD

Organizational Affiliation

Asociación para Evitar la Ceguera en México

Official's Role

Study Chair

Facility Information:

Facility Name

Asociación Para Evitar la Ceguera en México

City

Mexico City

State/Province

ZIP/Postal Code

04030

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yoko Burgoa

Phone

(52) 55 10841400

Ext

1172

12. IPD Sharing Statement

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Changes in Vitreous Temperature During Phacoemulsification

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