Phacoemulsification Under Topical Anesthesia and Its Complications

Phacoemulsification Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381783
• Other study ID #: facectopica
• Status: Completed
• Phase: Phase 1
• First received: April 7, 2011
• Last updated: June 24, 2011
• Start date: January 2006
• Est. completion date: April 2011

Study information

• Verified date: March 2011
• Source: Instituto de Oftalmologia Ivo Correa-Meyer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with cataract with a visual acuity less than 0.8

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Phacoemulsification

Intervention

Procedure:
• Phacoemulsification
Phacoemulsification under topical anesthesia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmologia Ivo Correa-Meyer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Postoperative events	To describe any postoperatives events in a phacoemulsification surgery under topical anesthesia	12 months	Yes