Clinical trial NCT02162381: Methylphenidate Effect on Humphrey Visual Fields
Official title: Methylphenidate Effect on Performing Humphrey Visual Fields
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Field Tests
Keywords: Humphrey visual fields
methylphenidate
attention deficit disorder
MoCa questionnaire
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study will include adults with abnormal visual fields. Half of them will be given either methylphenidate 10mg 2 hours before repeating the visual field test. the rest will serve as controls. All Subjects will also have a complete eye examination, a short questionnaire and a questionnaire to screen for attention deficit disorder. The investigators will compare the visual field results between the 2 tests.

Detailed description: Healthy adults with abnormal visual fields will be offered to participate Subjects will have a complete ophthalmic examination including dilated fundus examination.

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.

Eligibility criteria: Inclusion Criteria:

* abnormal visual fields
* must be able to swallow pills

Exclusion Criteria:

* psychiatric disorder
* 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

Primary outcomes:
measure: improvement rate of a repeat visual field result
timeFrame: immediate
Secondary outcomes:
measure: Humphrey visual field Mean Deviation (MD)
timeFrame: immediate
measure: Humphrey visual field severity score
timeFrame: immediate
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center - Beilinson campus
Study officials:
affiliation: Rabin Medical Center
name: Omer Y Bialer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. doi: 10.4065/75.7.711.
citation: Dodson WW. Pharmacotherapy of adult ADHD. J Clin Psychol. 2005 May;61(5):589-606. doi: 10.1002/jclp.20122.
citation: 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.