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

NCT ID: NCT01621789

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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

Conditions

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Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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dye of lutein, zeaxanthin, trypan blue

during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule

Group Type EXPERIMENTAL

dye of lutein, zeaxanthin, trypan blue

Intervention Type OTHER

dye composed of lutein, zeaxanthin, trypan blue

Interventions

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dye of lutein, zeaxanthin, trypan blue

dye composed of lutein, zeaxanthin, trypan blue

Intervention Type OTHER

Other Intervention Names

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combination of lutein, zeaxanthin, trypan blue

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rubens Belfort Jr.

Full Professor of Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rubens Belfort Jr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fderal University of São Paulo

Locations

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Dept. of Ophthalmology - UNIFESP/Hospital São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 25295905 (View on PubMed)

Other Identifiers

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CEP 2146/11

Identifier Type: -

Identifier Source: org_study_id

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