NCT01022879

Brief Summary

The use of topical anesthetics is a non invasive option avoiding local or general anesthesia in small gauge vitrectomy without causing intolerable pain

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for early_phase_1 pain

Timeline
Completed

Started May 2009

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

November 29, 2009

Last Update Submit

May 29, 2024

Conditions

Pain

Keywords

Pain scale of pain

Interventions

vitrectomyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pseudofaquic or faquic,
  • male or female,
  • to 80 years,
  • primary vitrectomy

You may not qualify if:

  • Combined surgery
  • Non cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Maria A Martinez-Castellanos, MD

    Asociación para Evitar la Ceguera en México

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2009

First Posted

December 1, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2009

Study Completion

May 1, 2010

Last Updated

May 30, 2024

Record last verified: 2024-05