Changes in Vitreous Temperature During Phacoemulsification | NCT01568242

Studies
Changes in Vitreous Temperature During Phacoemulsification

NCT01568242

Sponsor

Asociación para Evitar la Ceguera en México

Status

Withdrawn

Last Update Posted

May 30, 2024Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Proliferative Diabetic Retinopathy

Interventions

Phacoemlsification

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Undefined

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Apr 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 23, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Apr 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 29, 2024

Last Update Posted Date

May 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thermoprobe	Experimental	Determination of vitreous temperature with a thermoprobe	Device: Phacoemlsification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Phacoemlsification	Device	Transurgical measurement of temperature	Thermoprobe

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients from the Retina department that underwent phacoemulsification and vitrectomy

Exclusion Criteria:

Posterior capsule rupture

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hugo Quiroz-Mercado, MD	Asociación para Evitar la Ceguera en México	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asociación Para Evitar la Ceguera en México		Mexico City	Mexico City	04030	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided