Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000111279
Ethics application status
Approved
Date submitted
15/01/2009
Date registered
18/02/2009
Date last updated
18/02/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of memantine versus placebo on visual functions after scleral buckling for regmatogenous retinal detachment (RRD)
Scientific title
The effects of memantine versus placebo on visual acuity , optical coherence tomogapy (OCT) , contrast sensitivity , multifocal electroretinography (mERG) after scleral buckling for regmatogenous retinal detachment (RRD)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
patients with rhegmatogenus retinal detachment undergoing scleral buckeling surgery 4200 0
Condition category
Condition code
Eye 4410 4410 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention: Memantine tablets for treatment group for 3 weeks orally(5mg/day for the first week and 10 mg/ day for the next two weeks)
Intervention code [1] 3915 0
Treatment: Drugs
Comparator / control treatment
Placebo (550 miligram of lactose powder) for control group, daily for three weeks
Control group
Placebo

Outcomes
Primary outcome [1] 5294 0
Any change in visual acuity, testing by Early Treatment Diabetic Retinopathy Study (ETDRS) chart in LogMAR (Logarithmic value for Minimum Angle of Resolution)
Timepoint [1] 5294 0
Baseline, then on months 1, months 3
Secondary outcome [1] 8910 0
Any change in central macular thickness measured by optical coherence tomography (OCT)
Timepoint [1] 8910 0
Baseline, 3 months
Secondary outcome [2] 9176 0
Amplitudes of P waves in central macula measured by performing multifocal electroretinography (mERG) developed by Metrovision
Timepoint [2] 9176 0
3 months after operation
Secondary outcome [3] 9177 0
Contast sensitivity measurement in 4.8, 7.5, 12, & 15 cycle per degree measured by B-VATII Mentor
Timepoint [3] 9177 0
Baseline, 3 months

Eligibility
Key inclusion criteria
Macula off rhegmatogenus retinal detachment (RRD)
Duration<4 weeks
Proliferative vitreoretinopathy (PVR) A ;B
Visual acuity (V/A) < 20/200
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Usage of digoxin and dextrometorphan (interacting with memantine)
Pregnancy an nursing
Renal disease
Failure of surgery
Longstanding retinal detachment (RD)
Other macular pathology

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)
sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation depending on 1:duration of RD (<2 weeks and >2 weeks) and 2: patient lens status(phakic versus pseudophakic or aphakic) randomised by permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects, therapist or clinician, assessor, and data analyst were all masked
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 1528 0
Iran, Islamic Republic Of
State/province [1] 1528 0

Funding & Sponsors
Funding source category [1] 4384 0
University
Name [1] 4384 0
Ophthalmology department/ school of medicine/ Medical Sciences/ Tehran University
Country [1] 4384 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Tehran University of Medical sciences
Address
Tehran university, Enghelab Square, Tehran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3943 0
None
Name [1] 3943 0
Address [1] 3943 0
Country [1] 3943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6432 0
The investigational review board and ethics committees of Tehran University of Medical Sciences
Ethics committee address [1] 6432 0
Ethics committee country [1] 6432 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 6432 0
Approval date [1] 6432 0
Ethics approval number [1] 6432 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35091 0
Address 35091 0
Country 35091 0
Phone 35091 0
Fax 35091 0
Email 35091 0
Contact person for public queries
Name 12438 0
Mohammad Riazi-Esfahani MD
Address 12438 0
Farabi Eye Hospital, Qazvin Square, Tehran
Country 12438 0
Iran, Islamic Republic Of
Phone 12438 0
+98 9121446987
Fax 12438 0
+98 21 22678090
Email 12438 0
[email protected]
Contact person for scientific queries
Name 3366 0
Mohammad Riazi-Esfahani MD
Address 3366 0
Farabi Eye Hospital, Qazvin Square, Tehran
Country 3366 0
Iran, Islamic Republic Of
Phone 3366 0
+98 9121446987
Fax 3366 0
+98 21 22678090
Email 3366 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.