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

Cataract Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621789
• Other study ID #: CEP 2146/11
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2012
• Last updated: March 15, 2016
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: March 2016
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• dye of lutein, zeaxanthin, trypan blue
dye composed of lutein, zeaxanthin, trypan blue

Locations

Country	Name	City	State
Brazil	Dept. of Ophthalmology - UNIFESP/Hospital São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Vianna LM, Cohen MJ, Muccioli C, Lima A, Sousa-Martins D, Maia M, Belfort R Jr. Efficacy of a lutein-based dye (Phacodyne™) for visualizing anterior capsulorhexis during cataract surgery by phacoemulsification. Arq Bras Oftalmol. 2014 May-Jun;77(3):173-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visibility of the anterior lens capsule after the injection of dye	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	No
Secondary	Degree of impregnation of the dye	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	No
Secondary	usefulness of the dye	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	No