CataractPhase 3NCT01621789
Efficacy of Lutein, Zeaxanthine and Trypan Blue to Stain the Anterior Lens Capsule
A Phase 3 study testing dye of lutein, zeaxanthin, trypan blue in people with Cataract, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract
- What is being tested?
- dye of lutein, zeaxanthin, trypan blue
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 50 years
- Diagnosis of cataract (nuclear, entumecente, total)
- Absence of red reflex
- Indication of cataract surgery
Who cannot join
- Posterior subcapsular cataract
- Any history of eye disease
- Glaucoma
- Eye infection affecting any structure prior ocular
- Any previous ocular surgery
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Dept. of Ophthalmology - UNIFESP/Hospital São Paulo
São Paulo, São Paulo, 04023-062
About this study
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.
Effectiveness of lutein, zeaxanthin and trypan blue to stain the anterior lens capsule during cataract phacoemulsification.
Read the detailed description
Twenty patients with cataract (nuclear, entumecente, total) and indication for cataract surgery will be selected to participate in this study.
- Conditions
- Cataract
- Being tested
- dye of lutein, zeaxanthin, trypan blue
- Keywords
- lutein, zeaxanthin, trypan blue, dye
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dye of lutein, zeaxanthin, trypan blueOther
Also called combination of lutein, zeaxanthin, trypan blue
dye composed of lutein, zeaxanthin, trypan blue
| Study group | Role | What they receive |
|---|---|---|
| dye of lutein, zeaxanthin, trypan blue | Experimental | during the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule Receives: Other: dye of lutein, zeaxanthin, trypan blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during the cataract surgery
Secondary outcomes (2)
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)
Measured: during the surgery
usefulness of the dye
the physician should evaluate the usufelness of the dye, according to the following scale: Bad, Fair, Good, Fine
Measured: at the end of the cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rubens Belfort Jr., Federal University of São Paulo
- Investigators
- Rubens Belfort Jr, MD, PhD, Principal investigator, Fderal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621789
- Sponsor's protocol ID
- CEP 2146/11
- Status last verified
- Mar 2016
- First submitted
- 14 Jun 2012
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 25295905
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01621789
- Acronym / sponsor ID
- CEP 2146/11
- Conditions
- Cataract
- Keywords
- lutein, zeaxanthin, trypan blue, dye
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dye of lutein, zeaxanthin, trypan blue | Experimental | Other: dye of lutein, zeaxanthin, trypan blueduring the surgery will be evaluated if the dye is suitable for dyeing anterior lens capsule |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 50 years
- Diagnosis of cataract (nuclear, entumecente, total)
- Absence of red reflex
- Indication of cataract surgery
Key exclusion criteria (5 listed)
- Posterior subcapsular cataract
- Any history of eye disease
- Glaucoma
- Eye infection affecting any structure prior ocular
- Any previous ocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dye of lutein, zeaxanthin, trypan blueAlso: combination of lutein, zeaxanthin, trypan bluedye composed of lutein, zeaxanthin, trypan blue | Other | dye of lutein, zeaxanthin, trypan blue |
Primary outcome
Visibility of the anterior lens capsule after the injection of dye
Time frame: during the cataract surgery
The visibility of the anterior lens capsule after the injection of dye, should be graduated as Bad OR Fair OR Good OR Fine
2 secondary outcomes
Degree of impregnation of the dye
Time frame: during the surgery
usefulness of the dye
Time frame: at the end of the cataract surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Background: PubMed 25295905Vianna 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens Belfort Jr, MD, PhD principal investigator
Fderal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dye of lutein, zeaxanthin, trypan blue in people with Cataract, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visibility of the anterior lens capsule after the injection of dye (time frame: during the cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01621789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.