Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
This study is currently recruiting participants.
Verified November 2012 by Federal University of São Paulo
Sponsor:
Federal University of São Paulo
Information provided by (Responsible Party):
Rubens Belfort Jr., Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01627977
First received: June 22, 2012
Last updated: November 1, 2012
Last verified: November 2012
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Purpose
The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin and brilliant blue to stain the internal limiting membrane as well as the epiretinal membranes during the Vitrectomy surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Epiretinal Membrane Macular Hole Proliferative Diabetic Retinopathy |
Other: Dye of Lutein, Zeaxanthin and Brilliant Blue |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Descriptive Study to Evaluate the Effectiveness of the Dye Compound of the Combination of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy |
Resource links provided by NLM:
Further study details as provided by Federal University of São Paulo:
Primary Outcome Measures:
- Visibility of the membrane after injection of the dye [ Time Frame: during the surgery ] [ Designated as safety issue: No ]The visibility of the membrane after injection of the dye should be graduated by the physician as Bad, OR Fair, OR Good, OR Very Good
Secondary Outcome Measures:
- Degree of impregnation of the dye [ Time Frame: during the surgery ] [ Designated as safety issue: No ]The degree of impregnation of the membrane by the dye should be graduated according 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 [ Time Frame: at the end of surgery ] [ Designated as safety issue: No ]the physician should evaluate the usefulness of the dye, according to the following scale: Bad, Fair, Good, Very Good
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dye of Lutein/Zeaxanthin/Brilliant Blue
during the surgery will be evaluated if the dye is suitable for dyeing the internal limiting membrane as well as the epiretinal membrane
|
Other: Dye of Lutein, Zeaxanthin and Brilliant Blue
dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes
Other Name: lutein, zeaxanthin, brilliant blue
|
Detailed Description:
Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic retinopathy and indication of vitrectomy surgery will be selected to participate in this study.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients over 18 years, both gender
- Diagnosis of epiretinal membrane OR macular hole OR proliferative diabetic retinopathy
- Indication of surgical treatment for removal of the epiretinal membrane
Exclusion Criteria:
- Any history of eye disease
- glaucoma
- Eye infection affecting any structure provided eye
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627977
Contacts
| Contact: Mauricio Maia, MD | 55-18-91137727 | retina@femanet.com.br |
| Contact: Cristina Muccioli, MD | 55-11-5572-6443 | crissmucci@gmail.com |
Locations
| Brazil | |
| Depto. of Ophthalmology - Hospital São Paulo - UNIFESP | Recruiting |
| São Paulo, SP, Brazil, 04023-062 | |
| Contact: Mauricio Maia, MD 55-18-91137727 retina@femanet.com.br | |
| Contact: Cristina Muccioli, MD 55-11-5572-6443 crissmucci@gmail.com | |
| Principal Investigator: Rubens Belfort, MD | |
Sponsors and Collaborators
Federal University of São Paulo
Investigators
| Principal Investigator: | Rubens Belfort, MD | Federal University of São Paulo |
More Information
No publications provided
| Responsible Party: | Rubens Belfort Jr., Head Professor of the Departament of Ophthalmology, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT01627977 History of Changes |
| Other Study ID Numbers: | LUT-RET |
| Study First Received: | June 22, 2012 |
| Last Updated: | November 1, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Federal University of São Paulo:
|
chromovitrectomy epiretinal membrane |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Perforations Retinal Diseases Epiretinal Membrane Eye Diseases Diabetic Angiopathies |
Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013