Methylphenidate Effect on Humphrey Visual Fields

April 10, 2018 updated by: Bialer, Rabin Medical Center

Methylphenidate Effect on Performing 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
immediate
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
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Omer Y Bialer, M.D., Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

April 10, 2018

Study Completion (Actual)

April 10, 2018

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 11, 2014

First Posted (Estimate)

June 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0105-14-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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