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.
1 other identifier
interventional
25
1 country
1
Brief Summary
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 14, 2012
CompletedFirst Posted
Study publicly available on registry
June 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 16, 2016
March 1, 2016
1.1 years
June 14, 2012
March 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Degree of impregnation of the dye
during the surgery
usefulness of the dye
at the end of the cataract surgery
Study Arms (1)
dye of lutein, zeaxanthin, trypan blue
EXPERIMENTALduring the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule
Interventions
dye composed of lutein, zeaxanthin, trypan blue
Eligibility Criteria
You may qualify if:
- Patients over 50 years
- Diagnosis of cataract (nuclear, entumecente, total)
- Absence of red reflex
- Indication of cataract surgery
You may not qualify if:
- Posterior subcapsular cataract
- Any history of eye disease
- Glaucoma
- Eye infection affecting any structure prior ocular
- Any previous ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, 04023-062, Brazil
Related 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. doi: 10.5935/0004-2749.20140044.
PMID: 25295905BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubens Belfort Jr, MD, PhD
Fderal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor of Ophthalmology
Study Record Dates
First Submitted
June 14, 2012
First Posted
June 18, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2013
Study Completion
May 1, 2014
Last Updated
March 16, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will share