TerminatedNot Applicable

Effects of Prismatic Spectacle Lenses on Symptoms of Dizziness, Headache and Anxiety as Caused by Vertical Heterophoria

Stopped: Unable to recruit - multiple reasons.- inclusion/exclusion criteria too strict was th emain reason.

United States13 participantsStarted 2008-11

Plain-language summary

The purpose of this study is to demonstrate whether, in patients diagnosed with Vertical Heterophoria, the symptoms of dizziness, headache and / or anxiety are reduced or eliminated when a kind of correction called vertical prism is added to the patient's normal eye glass prescription. The experiment will involve giving the patient two pairs of glasses (one pair containing the baseline prescription with vertical prism (Standard Treatment Glasses) and the other pair containing the baseline prescription but without vertical prism (Placebo Glasses)) to demonstrate which pair of glasses is most effective in reducing the symptoms of dizziness, headache and / or anxiety in these patients.

Who can participate

Age range

14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * First time appointment for a patient at designated optometry office for treatment of symptoms associated with Vertical Heterophoria * Must have symptoms of dizziness or headache or both: * Dizziness defined as one or more of these: lightheadedness,dizziness, vertigo, feeling off-balance, lack of coordination / "clumsy", unsteadiness while walking or drifting / veering to one side while walking, motion sickness * Headache defined as one or more of these: pain anywhere in the head,posterior neck / upper trapezius (upper back), face, and in and / or around the eyes * Duration of symptoms greater than 4 months * Evaluated for these symptoms previously by at least 1 other doctor (General Practice, Family Practice, Internal Medicine, Neurology, ENT, Emergency Medicine, Pediatrics, PM\&R, Ophthalmology). * Age \>14 * The patient (or their representative) must be able and willing to fill out extra paperwork * All Patients to be seen by same Optometrist for all visits * Must be willing to wear glasses. * The patient (or their representative) must be able to sign informed consent * Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated * Must have a driver for Follow Up visits where Control and Treatment Glasses are dispensed, and when Washout period is initiated * Must have previous negative Neuroimaging (HCT or MRI) that was ordered to assess for headache and / or dizziness Exclusion…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evidence of change / improvement of symptoms of headache, dizziness and anxiety as demonstrated by validated, self-administered survey tools for these symptoms

Timeframe: Survey tools administered at baseline, 5-7 days after wearing the first pair of glasses, 5-7 days after wearing the second pair of glasses, and when treatment is completed

Trial details

NCT IDNCT00785135

SponsorVision Specialists of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

View on ClinicalTrials.gov More Binocular Dysfunction trials