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Completed

NCT Number: NCT01621789

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

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dept. of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, 04023-062, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dye of lutein, zeaxanthin, trypan blue

Other

dye composed of lutein, zeaxanthin, trypan blue

Other names: combination of lutein, zeaxanthin, trypan blue

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 18, 2012
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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