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

Primary Purpose

Cataract

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

dye of lutein, zeaxanthin, trypan blue

About this trial

This is an interventional supportive care trial for Cataract focused on measuring lutein, zeaxanthin, trypan blue, dye

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dept. of Ophthalmology - UNIFESP/Hospital São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dye of lutein, zeaxanthin, trypan blue

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

usefulness of the dye

the physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine

Full Information

NCT ID

NCT01621789

First Posted

June 14, 2012

Last Updated

March 15, 2016

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT01621789

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

lutein, zeaxanthin, trypan blue, dye

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dye of lutein, zeaxanthin, trypan blue

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

dye of lutein, zeaxanthin, trypan blue

Other Intervention Name(s)

combination of lutein, zeaxanthin, trypan blue

Intervention Description

dye composed of lutein, zeaxanthin, trypan blue

Primary Outcome Measure Information:

Title

Visibility of the anterior lens capsule after the injection of dye

Description

The visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine

Time Frame

during the cataract surgery

Secondary Outcome Measure Information:

Title

Degree of impregnation of the dye

Description

Time Frame

during the surgery

Title

usefulness of the dye

Description

the physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine

Time Frame

at the end of the cataract surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rubens Belfort Jr, MD, PhD

Organizational Affiliation

Fderal University of São Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Ophthalmology - UNIFESP/Hospital São Paulo

City

São Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

25295905

Citation

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.

Results Reference

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

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