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

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01621789
Enrollment
25
Registered
2012-06-18
Start date
2012-06-30
Completion date
2014-05-31
Last updated
2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

lutein, zeaxanthin, trypan blue, dye

Brief summary

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

Detailed description

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

Interventions

OTHERdye of lutein, zeaxanthin, trypan blue

dye composed of lutein, zeaxanthin, trypan blue

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visibility of the anterior lens capsule after the injection of dyeduring the cataract surgeryThe visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine

Secondary

MeasureTime frameDescription
Degree of impregnation of the dyeduring the surgeryThe 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 dyeat the end of the cataract surgerythe physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026