Methylphenidate Effect on Humphrey Visual Fields

NCT ID: NCT02162381

Last Updated: 2018-04-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-04-10

Brief Summary

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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

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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.

Conditions

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Visual Field Tests

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

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

Group Type EXPERIMENTAL

methylphenidate

Intervention Type DRUG

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

guidance

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

guidance

Intervention Type OTHER

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

Intervention Type DRUG

guidance

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

Intervention Type OTHER

Other Intervention Names

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Ritalin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Bialer

Dr. Omer Y. Bialer

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Israel

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.

Reference Type BACKGROUND
PMID: 18494726 (View on PubMed)

Challman TD, Lipsky JJ. Methylphenidate: its pharmacology and uses. Mayo Clin Proc. 2000 Jul;75(7):711-21. doi: 10.4065/75.7.711.

Reference Type BACKGROUND
PMID: 10907387 (View on PubMed)

Dodson WW. Pharmacotherapy of adult ADHD. J Clin Psychol. 2005 May;61(5):589-606. doi: 10.1002/jclp.20122.

Reference Type BACKGROUND
PMID: 15723384 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33342320 (View on PubMed)

Other Identifiers

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0105-14-RMC

Identifier Type: -

Identifier Source: org_study_id

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