NCT02691429

Brief Summary

Our research group tested the toxicity of different dye concentrations extracted from the acai fruit using a rabbit model. The dye extracted from the acai fruit in concentrations of 10% and 25% was found to be safe for vitreoretinal surgery. This initial research represented the landmark research for testing this alternative vital dye in a clinical research in humans. The aim of the present clinical trial in humans will be to test the applicability of the acai dye in the identification of the posterior hyaloid and ILM during vitreoretinal surgery in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

February 22, 2016

Last Update Submit

June 5, 2017

Conditions

Epiretinal MembraneMacular HoleDiabetic Retinopathy

Keywords

Vitreoretinal surgeryeuterpe oleraceachromovitrectomy

Outcome Measures

Primary Outcomes (1)

  • ocular inflammation

    signs of ocular inflammation

    up to 30 days

Secondary Outcomes (2)

  • intraocular pressure

    up to 30 days

  • complications of the posterior segment

    up to 30 days

Study Arms (2)

acai dye (Euterpe oleracea) 10%

ACTIVE COMPARATOR

Twenty-four different retina surgeons will operate one of the 24 selected patients, using the standard vitrectomy technique that employs 4 sclerotomies and a 23-gauge system with accessory illumination. All surgeries will be performed using the acai dye (Euterpe oleracea) in the following concentrations: 10% (n=12) or 25% (n=12). Immediately after the procedure, each surgeon will be given an evaluation questionnaire to fill-in

Other: Acai dye 10%

acai dye (Euterpe oleracea) 25%

ACTIVE COMPARATOR

Twenty-four different retina surgeons will operate one of the 24 selected patients, using the standard vitrectomy technique that employs 4 sclerotomies and a 23-gauge system with accessory illumination. All surgeries will be performed using the acai dye (Euterpe oleracea) in the following concentrations: 10% (n=12) or 25% (n=12). Immediately after the procedure, each surgeon will be given an evaluation questionnaire to fill-in

Other: Acai dye 10%

Interventions

Acai dye 10%OTHER

dye to be used during chromovitrectomy in humans

Also known as: euterpe oleracea dye
acai dye (Euterpe oleracea) 10%acai dye (Euterpe oleracea) 25%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with epiretinal membrane, macular hole or proliferative diabetic retinopathy (with or without vitreous hemorrhage).
  • Indicated for surgical removal of the epiretinal memebrane (with or without removal of the internal limiting membrane).

You may not qualify if:

  • \- Previous ocular pathology
  • Glaucoma
  • Any other previous ocular infection that would modify ocular anatomy.

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

Location

MeSH Terms

Conditions

Epiretinal MembraneRetinal PerforationsDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Mauricio Maia

    Federal University of São Paulo UNIFESP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

February 1, 2016

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

June 7, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)