Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2014-06-30
2018-04-10
Brief Summary
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Detailed Description
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Subjects with clear explanation for a visual field defect (e.g. optic neuropathy or retinal disorder) will be excluded from the study the subjects will be randomly assigned to the study group and control group using a 1:1 allocation.
Subjects in the study group will be provided with a single tablet of methylphenidate 10 mg to be taken orally 2 hours before repeating their visual field test.
The control group will not receive any placebo Both groups will repeat their visual fields. Both groups will fill out a short questionnaire to evaluate their experience in the second visual field test.
The study group will also fill out a screening questionnaire to rule out previously undiagnosed attention deficit disorder.
Two experienced ophthalmologists will separately interpret the visual fields results and compare the first and second visual fields of each subject, while being blinded to which group he was in.
Subjects will be provided with their test results and the ophthalmologist interpretation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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methylphenidate provided
the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test
methylphenidate
a single dose of methylphenidate 10 mg to be taken orally in the morning
guidance
subjects will be given an explanation and advice about how to perform well in visual field testing
control
control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation
guidance
subjects will be given an explanation and advice about how to perform well in visual field testing
Interventions
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methylphenidate
a single dose of methylphenidate 10 mg to be taken orally in the morning
guidance
subjects will be given an explanation and advice about how to perform well in visual field testing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* must be able to swallow pills
Exclusion Criteria
* dementia
* ocular disorder which is known to cause abnormal visual fields
* prescription of psychoactive medications
* visual acuity lower than 20/100
* cardiac arrhythmia
* hypersensitivity to methylphenidate
* prescription of warfarin
18 Years
120 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Bialer
Dr. Omer Y. Bialer
Principal Investigators
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Omer Y Bialer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Rabin Medical Center - Beilinson campus
Petah Tikva, , Israel
Countries
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References
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Martin L, Aring E, Landgren M, Hellstrom A, Andersson Gronlund M. Visual fields in children with attention-deficit / hyperactivity disorder before and after treatment with stimulants. Acta Ophthalmol. 2008 May;86(3):259-64. doi: 10.1111/j.1755-3768.2008.01189.x.
Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. doi: 10.4065/75.7.711.
Dodson WW. Pharmacotherapy of adult ADHD. J Clin Psychol. 2005 May;61(5):589-606. doi: 10.1002/jclp.20122.
Sternfeld A, Bialer OY, Keidar D, Megiddo E, Budnik I, Stiebel-Kalish H, Livnat T. A Single Low-Dose of Methylphenidate Improves Abnormal Visual Field Testing. Curr Eye Res. 2021 Aug;46(8):1232-1239. doi: 10.1080/02713683.2020.1858430. Epub 2020 Dec 21.
Other Identifiers
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0105-14-RMC
Identifier Type: -
Identifier Source: org_study_id
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