Methylphenidate Effect on Humphrey Visual Fields
- Conditions
- Visual Field Tests
- Interventions
- Other: guidance
- Registration Number
- NCT02162381
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- abnormal visual fields
- must be able to swallow pills
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description methylphenidate provided methylphenidate the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test methylphenidate provided guidance the study group will be given a single pill containing methylphenidate 10mg to be taken 2 hours before their visual field test control guidance control group will not be given any placebo and will perform a repeat visual field testing without any prior preparation
- Primary Outcome Measures
Name Time Method improvement rate of a repeat visual field result 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
Name Time Method Humphrey visual field Mean Deviation (MD) immediate the MD of the Humphrey visual field in the study and control groups will be compared
Humphrey visual field severity score 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
Trial Locations
- Locations (1)
Rabin Medical Center - Beilinson campus
🇮🇱Petah-Tikva, Israel