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

March 15, 2016 updated by: Rubens Belfort Jr., Federal University of São Paulo

A Descriptive Study to Evaluate the Efficacy of the Dye Compound of the Combination of Lutein, Zeaxanthin and Trypan Blue to Stain the Anterior Lens Capsule During Cataract Phacoemulsification.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04023-062
        • Dept. of Ophthalmology - UNIFESP/Hospital São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients over 50 years
  • Diagnosis of cataract (nuclear, entumecente, total)
  • Absence of red reflex
  • Indication of cataract surgery

Exclusion Criteria

  • Posterior subcapsular cataract
  • Any history of eye disease
  • Glaucoma
  • Eye infection affecting any structure prior ocular
  • Any previous ocular surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dye of lutein, zeaxanthin, trypan blue
during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule
Other: dye of lutein, zeaxanthin, trypan blue
dye composed of lutein, zeaxanthin, trypan blue
Other Names:
  • combination of lutein, zeaxanthin, trypan blue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visibility of the anterior lens capsule after the injection of dye
Time Frame: 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
during the cataract surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of impregnation of the dye
Time Frame: 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)
during the surgery
usefulness of the dye
Time Frame: 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
at the end of the cataract surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Rubens Belfort Jr, MD, PhD, Fderal University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 14, 2012

First Submitted That Met QC Criteria

June 15, 2012

First Posted (Estimate)

June 18, 2012

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 2146/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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