Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000265572
Ethics application status
Not yet submitted
Date submitted
26/06/2006
Date registered
29/06/2006
Date last updated
29/06/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Cystoid Macular Edema Associated With Topical Latanoprost in Patients that Underwent Uncomplicated Cataract Surgery
Scientific title
Cystoid Macular Edema Associated With Topical Latanoprost in Patients that Underwent Uncomplicated Cataract Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystoid Macular Edema 1242 0
Condition category
Condition code
Eye 1327 1327 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients that underwent uncomplicated cataract surgery will be randomized to use topical latanoprost 0.005% eye-drop q.d. (n=10) for 1 month.
They will be submitted to optical coherence tomography (OCT) evaluation at baseline and after 15 days and 1 month of treatment.
Intervention code [1] 1164 0
Other interventions
Comparator / control treatment
Patients that underwent uncomplicated cataract surgery will be randomized to use topical placebo eye-drop q.d. containing benzalkonium chloride 0.01% (n=10) for 1 month.
Control group
Placebo

Outcomes
Primary outcome [1] 1813 0
Macular thickness changes
Timepoint [1] 1813 0
15 days and 1 month
Secondary outcome [1] 3179 0
Is benzalkonium chloride associated with development of cystoid macular edema after 1 month of use in patients that underwent uncomplicated cataract surgery.
Timepoint [1] 3179 0

Eligibility
Key inclusion criteria
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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 362 0
Brazil
State/province [1] 362 0

Funding & Sponsors
Funding source category [1] 1454 0
University
Name [1] 1454 0
Federal University of Uberlândia
Country [1] 1454 0
Brazil
Primary sponsor type
University
Name
Federal University of Uberlândia
Address
Country
Brazil
Secondary sponsor category [1] 1283 0
None
Name [1] 1283 0
none
Address [1] 1283 0
Country [1] 1283 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 2831 0
Ethics Committee of the Federal University of Uberlândia
Ethics committee address [1] 2831 0
Ethics committee country [1] 2831 0
Brazil
Date submitted for ethics approval [1] 2831 0
Approval date [1] 2831 0
Ethics approval number [1] 2831 0

Summary
Brief summary
The primary purpose of the protocol is to study prospectively using optical coherence tomography (OCT) whether topical latanoprost induces retinal disorders, such as cystoid macular edema, in patients that underwent uncomplicated cataract surgery.
The use of topical latanoprost eye-drop may be associated or not with changes in macular thickness.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35510 0
Address 35510 0
Country 35510 0
Phone 35510 0
Fax 35510 0
Email 35510 0
Contact person for public queries
Name 10353 0
Enyr Saran Arcieri
Address 10353 0
Rua Corcovado, n 155 - ap 402
Uberlândia - Minas Gerais
CEP 38411-092
Country 10353 0
Brazil
Phone 10353 0
55-34-32559090
Fax 10353 0
55-34-32559090
Email 10353 0
[email protected]
Contact person for scientific queries
Name 1281 0
Enyr Saran Arcieri
Address 1281 0
Rua Corcovado, n 155 - ap 402
Uberlândia - Minas Gerais - Brasil
CEP 38411-092
Country 1281 0
Brazil
Phone 1281 0
55-34-32559090
Fax 1281 0
55-34-32559090
Email 1281 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.