Methylphenidate Effect on Humphrey Visual Fields

Visual Field Tests Clinical Trial

Official title:

Methylphenidate Effect on Performing Humphrey Visual Fields

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162381
• Other study ID #: 0105-14-RMC
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: April 10, 2018
• Start date: June 2014
• Est. completion date: April 10, 2018

Study information

• Verified date: April 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 10, 2018
• Est. primary completion date: April 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Visual Field Tests

Intervention

Drug:
• methylphenidate
a single dose of methylphenidate 10 mg to be taken orally in the morning

Other:
• guidance
subjects will be given an explanation and advice about how to perform well in visual field testing

Locations

Country	Name	City	State
Israel	Rabin Medical Center - Beilinson campus	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. Review. — View Citation

Dodson WW. Pharmacotherapy of adult ADHD. J Clin Psychol. 2005 May;61(5):589-606. Review. — View Citation

Martin L, Aring E, Landgren M, Hellström A, Andersson Grönlund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement rate of a repeat visual field result	the percentage of subjects whose second (repeat) visual field has improved compared to the first visual field - as interpreted by independent blinded ophthalmologists	immediate
Secondary	Humphrey visual field Mean Deviation (MD)	the MD of the Humphrey visual field in the study and control groups will be compared	immediate
Secondary	Humphrey visual field severity score	based on the Humphrey visual field gray scale each visual field will be given a score between 1 and 4. 1 = normal 2=enlargement of the blind spot 3=either a nasal or temporal visual field 4= diffuse visual field loss	immediate