Phacoemulsification Under Topical Anesthesia and Its Complications

This study has been completed.
Sponsor:
Information provided by:
Instituto de Oftalmologia Ivo Correa-Meyer
ClinicalTrials.gov Identifier:
NCT01381783
First received: April 7, 2011
Last updated: June 24, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to determine if topical anesthesia is safe for phacoemulsification in eyes with comorbidities.


Condition Intervention Phase
Phacoemulsification
Procedure: Phacoemulsification
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Instituto de Oftalmologia Ivo Correa-Meyer:

Primary Outcome Measures:
  • Number of Postoperative events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    To describe any postoperatives events in a phacoemulsification surgery under topical anesthesia


Estimated Enrollment: 111
Study Start Date: January 2006
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Topical anesthesia Procedure: Phacoemulsification
Phacoemulsification under topical anesthesia

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with cataract with a visual acuity less than 0.8

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Manuel Augusto Pereira Vilela, Instituto de Oftalmologia Ivo Correa-Meyer
ClinicalTrials.gov Identifier: NCT01381783     History of Changes
Other Study ID Numbers: facectopica
Study First Received: April 7, 2011
Last Updated: June 24, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Instituto de Oftalmologia Ivo Correa-Meyer:
topical anaesthesia
Phacoemulsification

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014