NCT01568242

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

February 23, 2012

Last Update Submit

May 29, 2024

Conditions

Proliferative Diabetic Retinopathy

Keywords

CataractPhacoemulsificationTemperatureVitreous

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Thermoprobe

EXPERIMENTAL

Determination of vitreous temperature with a thermoprobe

Device: Phacoemlsification

Interventions

PhacoemlsificationDEVICE

Transurgical measurement of temperature

Also known as: Thermoprobe
Thermoprobe

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients from the Retina department that underwent phacoemulsification and vitrectomy

You may not qualify if:

  • Posterior capsule rupture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Para Evitar la Ceguera en México

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Hugo Quiroz-Mercado, MD

    Asociación para Evitar la Ceguera en México

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

April 2, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

May 30, 2024

Record last verified: 2024-05

Locations

ME(1)