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NCT Number: NCT02162381

Methylphenidate Effect on Humphrey Visual Fields

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.

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Key information

Conditions

Visual Field Tests Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rabin Medical Center - Beilinson campus

Petah Tikva, 49100, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

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

Other names: Ritalin

guidance

Other

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

Primary outcomes

  1. improvement rate of a repeat visual field result

    Time frame: immediate

    the percentage of subjects whose second (repeat) visual field has improved compared to the first visual field - as interpreted by independent blinded ophthalmologists

Secondary outcomes

  1. Humphrey visual field Mean Deviation (MD)

    Time frame: immediate

    the MD of the Humphrey visual field in the study and control groups will be compared

  2. Humphrey visual field severity score

    Time frame: immediate

    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

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Methylphenidate Effect on Performing Humphrey Visual Fields

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2014
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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