Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule

Phase 3

Completed

• Conditions: Cataract
• Interventions: Other: dye of lutein, zeaxanthin, trypan blue

• Registration Number: NCT01621789
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.

Detailed Description

Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-14
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Primary Completion: 2013-07
• Study Completion: 2014-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dye of lutein, zeaxanthin, trypan blue	dye of lutein, zeaxanthin, trypan blue	during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule

Primary Outcome Measures

Name	Time	Method
Visibility of the anterior lens capsule after the injection of dye	during the cataract surgery	The visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine

Secondary Outcome Measures

Name	Time	Method
Degree of impregnation of the dye	during the surgery	The degree of impregnation of the anterior lens capsule by the dye should be graduated acording to the following scale:(0)not flushed; (1)stained weakly (light green); (2)moderately stained (medium green); (3)stained intensely (dark green)
usefulness of the dye	at the end of the cataract surgery	the physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine

Trial Locations

Locations (1)

Dept. of Ophthalmology - UNIFESP/Hospital São Paulo; 🇧🇷 São Paulo, SP, Brazil