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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01621789
First Posted: June 18, 2012
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
  Purpose
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.

Condition Intervention Phase
Cataract Other: dye of lutein, zeaxanthin, trypan blue Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Rubens Belfort Jr., Federal University of São Paulo:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)

  • 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


Enrollment: 25
Study Start Date: June 2012
Study Completion Date: May 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: combination of lutein, zeaxanthin, trypan blue

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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621789


Locations
Brazil
Dept. of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, SP, Brazil, 04023-062
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Rubens Belfort Jr, MD, PhD Fderal University of São Paulo
  More Information

Publications:
Responsible Party: Rubens Belfort Jr., Full Professor of Ophthalmology, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01621789     History of Changes
Other Study ID Numbers: CEP 2146/11
First Submitted: June 14, 2012
First Posted: June 18, 2012
Last Update Posted: March 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Rubens Belfort Jr., Federal University of São Paulo:
lutein
zeaxanthin
trypan blue
dye

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Diminazene aceturate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Trypanocidal Agents