Concussion, Mild, Convergence Insufficiency, Accommodation; Insufficiency
Conditions
Brief summary
We will be looking at 3 treatment arms in the form of different type of glasses to see if one is superior to helping kids have sustained a concussion and are symptomatic.
Detailed description
Recent studies have shown children who sustain a concussion are susceptible to having chronic symptoms (post-concussion syndrome). This chronicity can lead to delays in returning to learn and returning to play. Blurry vision, double vision, eye strain and eye tracking problems are some of the reported chronic symptoms that can affect patients' daily activities. Concussion awareness has increased recently and there is a surge of interest to better understand and treat the symptoms of post-concussion syndrome. Currently, ocular treatment for patients are often empirically determined. Common treatments are vision therapy and/or bifocal glasses. There has yet to be any standardization or prospective studies looking into treatment for these concussed patients with ocular symptoms and findings. The objective of this protocol is to compare three different types of glasses (typical prescription glasses for kids, typical glasses for kids with anti-glare coating, and progressive addition lenses with anti-glare coating) as treatment options for participants who are still symptomatic four weeks out from their concussion. The main outcome is the effectiveness of these three different options in reducing patients' symptoms and improving the participants' visual findings.
Interventions
DEVICEGlasses
Glasses traditionally prescribed for refractive error
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Sustained a concussion \> 6 weeks \< 16 weeks from date of initial visit * Criteria for concussion: formally diagnosed by physician * Minimum best corrected visual acuity: 20/25 in right and left eyes at distance and 20/30 both eyes at near * Minimum Stereopsis: 500 global * CISS score \> 16 * Refractive error at least + 0.50D sphere or cylinder * Ability to clear \> 0.50 cycles per minute in monocular accommodative flipper of and binocular accommodative flipper of +/-1.50
Exclusion criteria
* Diplopia from nerve palsies * Retinal pathology * Previous treatment of any amount of bifocal lenses and base in prism since concussion. * Vision therapy \> 6 weeks since concussion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Convergence Insufficiency Symptom Survey | Assessed up to 12 months | This survey quantifies convergence insufficiency symptoms on a scale. The scale measures the severity of symptoms from the condition, convergence insufficiency. Score on a scale can range from 0 (least) to 60 (worst). This survey has been proven to be an effective and accurate gauge by previous research and study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Convergence Breaking Point at Near (Base Out Prism) | Assessed up to 12 months | This outcome measurement was the maximum base out prism diopters when the patient first reported diplopia of a near target or started suppressing one of the eyes as determined by the examiner. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Vision Glasses Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours.
Glasses: Glasses traditionally prescribed for refractive error | 1 |
| Single Vision Glasses With Anti-glare Coating Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours.
Glasses: Glasses traditionally prescribed for refractive error | 1 |
| Eyezen Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours
Glasses: Glasses traditionally prescribed for refractive error | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Single Vision Glasses | Single Vision Glasses With Anti-glare Coating | Eyezen | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 17 years | 14 years | 16 years | 16 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 | 0 / 3 |
| other Total, other adverse events | 0 / 1 | 0 / 1 | 0 / 3 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 3 |
Outcome results
Primary
Convergence Insufficiency Symptom Survey
This survey quantifies convergence insufficiency symptoms on a scale. The scale measures the severity of symptoms from the condition, convergence insufficiency. Score on a scale can range from 0 (least) to 60 (worst). This survey has been proven to be an effective and accurate gauge by previous research and study groups.
Time frame: Assessed up to 12 months
Population: All participants met the criteria of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Vision Glasses | Convergence Insufficiency Symptom Survey | 29 score on a scale | Standard Deviation 0 |
| Single Vision Glasses With Anti-glare Coating | Convergence Insufficiency Symptom Survey | 22 score on a scale | Standard Deviation 0 |
| Eyezen | Convergence Insufficiency Symptom Survey | 14 score on a scale | Standard Deviation 0 |
Secondary
Convergence Breaking Point at Near (Base Out Prism)
This outcome measurement was the maximum base out prism diopters when the patient first reported diplopia of a near target or started suppressing one of the eyes as determined by the examiner.
Time frame: Assessed up to 12 months
Population: All participants meet inclusion criteria. However, 2 of the 5 participants did not return for the follow up visit and therefore do not have outcome measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Vision Glasses | Convergence Breaking Point at Near (Base Out Prism) | 16 prism diopters | Standard Deviation 0 |
| Single Vision Glasses With Anti-glare Coating | Convergence Breaking Point at Near (Base Out Prism) | 40 prism diopters | Standard Deviation 0 |
| Eyezen | Convergence Breaking Point at Near (Base Out Prism) | 12 prism diopters | Standard Deviation 0 |