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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
History of Changes
  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
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 May 16, 2013