Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000266561
Ethics application status
Not yet submitted
Date submitted
27/06/2006
Date registered
29/06/2006
Date last updated
29/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
MACULAR THICKNESS CHANGES FOLLOWING THE USE OF PROSTAGLANDIN ANALOGUES IN PSEUDOPHAKIC PATIENTS
Scientific title
MACULAR THICKNESS CHANGES FOLLOWING THE USE OF PROSTAGLANDIN ANALOGUES IN PSEUDOPHAKIC PATIENTS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular thickness will be evaluated accurately using optical coherence tomography (OCT) in pseudophakic patients using prostaglandin analogues 1243 0
Condition category
Condition code
Eye 1328 1328 0 0
Normal eye development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients that underwent uncomplicated cataract surgery will be randomized to use topical bimatoprost 0.03% eye-drop q.d. (n=10), topical latanoprost 0.005% eye-drop q.d. (n=10), or topical travoprost 0.004% eye-drop q.d. (n=10) for 1 month.
Macular thickness will be evaluate using OCT at baseline, 15 days and 1 month.

The baseline will be used as control.
Intervention code [1] 1169 0
Treatment: Drugs
Comparator / control treatment
No control intervention.
Control group
Active

Outcomes
Primary outcome [1] 1814 0
Macular thickness changes after use of prostaglandin analogues in pseudophakic eyes.
Timepoint [1] 1814 0
At baseline, 15 days and 1 month.
Secondary outcome [1] 3180 0
None
Timepoint [1] 3180 0

Eligibility
Key inclusion criteria
Patients in the study will be subjects that underwent uneventful cataract surgery with intraocular lens implantation and that have follow-up visits at Ophthalmology Service – Federal University of Uberlândia.Patients were eligible for participation if they met the following inclusion criteria: pseudophakia, uneventful cataract surgery, and visual acuity better than 20/40.
Minimum age
40 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they had a prior history of uveitis or CME, substantial ocular irritation at baseline, or history of intraocular surgery or laser procedure within 4 months before baseline. We also excluded patients who had been treated with PG analogues in the past, and patients who had undergone other ocular surgery except for cataract. Finally, the presence of systemic disorders that could be associated with either uveitis or CME (i.e. diabetes, rheumatologic diseases), pregnancy, lactation or inadequate contraception (in females) were also exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be submitted to optical coherence tomography (OCT) evaluation at baseline and after 15 days and 1 month of treatment. A designated unmasked coordinator – who did not perform any study evaluation or assessment – will receive randomization codes, dispense the medications and instruct the patients on how to use and store the containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The web program Research Randomizer v3.0 (www.randomizer.org) will be use for random assignment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 368 0
Brazil
State/province [1] 368 0

Funding & Sponsors
Funding source category [1] 1455 0
University
Name [1] 1455 0
Federal University of Uberlândia
Country [1] 1455 0
Brazil
Primary sponsor type
University
Name
Federal University of Uberlândia
Address
Country
Brazil
Secondary sponsor category [1] 1284 0
None
Name [1] 1284 0
none
Address [1] 1284 0
Country [1] 1284 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2832 0
Ethics Committee of the Federal University of Uberlândia
Ethics committee address [1] 2832 0
Ethics committee country [1] 2832 0
Brazil
Date submitted for ethics approval [1] 2832 0
Approval date [1] 2832 0
Ethics approval number [1] 2832 0

Summary
Brief summary
The primary purpose of the protocol is to investigate the effects of prostaglandin analogues on the macular thickness in pseudophakic patients.
Hypothesis: 1) The use of prostaglandin analogues in pseudophakic patients changes the macular thickness / 2) The use of prostaglandin analogues in pseudophakic patients does not change the macular thickness
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35159 0
Address 35159 0
Country 35159 0
Phone 35159 0
Fax 35159 0
Email 35159 0
Contact person for public queries
Name 10358 0
Enyr Saran Arcieri
Address 10358 0
Rua Corcovado, n 155 - apto 402
Bairro Patrimônio
Uberlândia - Minas Gerais
CEP 38411-092
Country 10358 0
Brazil
Phone 10358 0
55-34-32559090
Fax 10358 0
55-34-32559090
Email 10358 0
[email protected]
Contact person for scientific queries
Name 1286 0
Enyr Saran Arcieri
Address 1286 0
Rua Corcovado, n 155 - apto 402
Bairro Patrimônio
Uberlândia - Minas Gerais - Brasil
CEP 38411-092
Country 1286 0
Brazil
Phone 1286 0
55-34-32559090
Fax 1286 0
55-34-32559090
Email 1286 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.