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Trial record 16 of 439 for:    Methylphenidate

Methylphenidate Effect on Humphrey Visual Fields

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ClinicalTrials.gov Identifier: NCT02162381
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Bialer, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Visual Field Tests Drug: methylphenidate Other: guidance Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Methylphenidate Effect on Performing Humphrey Visual Fields
Study Start Date : June 2014
Actual Primary Completion Date : April 10, 2018
Actual Study Completion Date : April 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: methylphenidate provided
the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test
Drug: methylphenidate
a single dose of methylphenidate 10 mg to be taken orally in the morning
Other Name: Ritalin

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

Active Comparator: control
control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation
Other: guidance
subjects will be given an explanation and advice about how to perform well in visual field testing




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162381


Locations
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Israel
Rabin Medical Center - Beilinson campus
Petah-Tikva, Israel, 49100
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Omer Y Bialer, M.D. Rabin Medical Center

Publications:
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Responsible Party: Bialer, Dr. Omer Y. Bialer, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02162381     History of Changes
Other Study ID Numbers: 0105-14-RMC
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Keywords provided by Bialer, Rabin Medical Center:
Humphrey visual fields
methylphenidate
attention deficit disorder
MoCa questionnaire
Additional relevant MeSH terms:
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Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents