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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01621789
First received: June 14, 2012
Last updated: March 15, 2016
Last verified: March 2016
  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: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 14, 2012
Last Updated: March 15, 2016
Health Authority: Brazil: National Health Surveillance Agency
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by 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

ClinicalTrials.gov processed this record on August 25, 2016