NCT02162381

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

3.9 years

First QC Date

June 10, 2014

Last Update Submit

April 10, 2018

Conditions

Visual Field Tests

Keywords

Humphrey visual fieldsmethylphenidateattention deficit disorderMoCa questionnaire

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Humphrey visual field Mean Deviation (MD)

    immediate

  • Humphrey visual field severity score

    immediate

Study Arms (2)

methylphenidate provided

EXPERIMENTAL

the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test

Drug: methylphenidateOther: guidance

control

ACTIVE COMPARATOR

control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation

Other: guidance

Interventions

methylphenidateDRUG

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

Also known as: Ritalin
methylphenidate provided
guidanceOTHER

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

controlmethylphenidate provided

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • abnormal visual fields
  • must be able to swallow pills

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center - Beilinson campus

Petah Tikva, 49100, Israel

Location

Related Publications (4)

  • 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.

    PMID: 18494726BACKGROUND

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

    PMID: 10907387BACKGROUND

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

    PMID: 15723384BACKGROUND

  • 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.

    PMID: 33342320DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MethylphenidateCounseling

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Omer Y Bialer, M.D.

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Omer Y. Bialer

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 12, 2014

Study Start

June 1, 2014

Primary Completion

April 10, 2018

Study Completion

April 10, 2018

Last Updated

April 11, 2018

Record last verified: 2018-04

Locations

IL(1)