CataractNCT01800708
Cataract Surgery With Intracameral Triamcinolone in Infants
A study testing Triamcinolone acetonide and Prednisolone syrup in people with Cataract, run by Fundação Altino Ventura at 1 site in Brazil.
Trial summary
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone. This is a prospective, randomized clinical trial. Read more about this study
- Who is it for?
- Ages 6 weeks to 2 years
- Conditions the study is for
- Cataract
- What is being tested?
- Triamcinolone acetonide and Prednisolone syrup
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Mar 2013
- Phase
- Interventional
- 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 6 weeks to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients younger than 2 years of age
- Unilateral or bilateral congenital cataracts compromising the red reflex
Who cannot join
- Corneal opacity
- Glaucoma
- Aniridia
- Subluxated cataract
- Traumatic cataract
- Complex microphthalmia
Show all 9Show fewer
- Persistant hyperplastic primary vitreous
- Retinal detachment
- Patients with intraoperative complications, such as IOL implanted in the sulcus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.
This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.
- Conditions
- Cataract
- Being tested
- Triamcinolone acetonide, Prednisolone syrup
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone acetonideDrug
Also called Triancinolona Ophthalmos
Prednisolone syrupDrug
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone acetonide | Active comparator | The study group will receive an intraoperative intracameral injection of triamcinolone acetonide Receives: Drug: Triamcinolone acetonide |
| Prednisolone syrup | Active comparator | The control group will receive prednisolone syrup postoperatively Receives: Drug: Prednisolone syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual axis obscuration
Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.
Measured: 1 year after surgery
Intraocular pressure
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2013 (estimated)
- Study startJan 2010
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundação Altino Ventura
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcelo Ventura, MD, Principal investigator, Fundação Altino Ventura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800708
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2013
- First submitted
- 25 Feb 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
- ClinicalTrials.gov ID
- NCT01800708
- Acronym / sponsor ID
- 1
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundação Altino VenturaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2013 (actual)
- First posted
- 28 Feb 2013 (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.
The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone.
This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone acetonide | Active comparator | Drug: Triamcinolone acetonideThe study group will receive an intraoperative intracameral injection of triamcinolone acetonide |
| Prednisolone syrup | Active comparator | Drug: Prednisolone syrupThe control group will receive prednisolone syrup postoperatively |
Who may qualify
- Ages
- 6 weeks to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients younger than 2 years of age
- Unilateral or bilateral congenital cataracts compromising the red reflex
Key exclusion criteria (9 listed)
- Corneal opacity
- Glaucoma
- Aniridia
- Subluxated cataract
- Traumatic cataract
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 |
|---|---|---|
| Triamcinolone acetonideAlso: Triancinolona Ophthalmos | Drug | Triamcinolone acetonide |
| Prednisolone syrup | Drug | Prednisolone syrup |
Primary outcome
Visual axis obscuration
Time frame: 1 year after surgery
Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.
Intraocular pressure
Time frame: 1 year after 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 14 Aug 2013.
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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.
Marcelo Ventura, MD principal investigator
Fundação Altino Ventura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone acetonide and Prednisolone syrup in people with Cataract, run by Fundação Altino Ventura 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 2 inclusion and 9 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 14 Aug 2013. 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.
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?
Visual axis obscuration (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2013.