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Not enough interest/participants. Recruitment was more difficult due to pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single vision glasses | Experimental | Typical glasses prescribed for children to correct only distance refractive error and to be worn all waking hours. |
|
| Single vision glasses with anti-glare coating | Experimental | Typical glasses prescribed for children to correct only distance prescription with anti-glare coating and to be worn all waking hours. |
|
| Eyezen | Experimental | Commercially available, low-powered, progressive addition lenses glasses with anti-glare coating to be worn all waking hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glasses | Device | Glasses traditionally prescribed for refractive error |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Becky Luu, OD | University of Alabama at Birmingham | Study Director |
| Katherine Weise, OD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama School of Optometry | Birmingham | Alabama | 35233 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
It is not different from the assignment in participant flow
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Single Vision Glasses With Anti-glare Coating |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants met the criteria of the study | Posted | Mean | Standard Deviation | score on a scale | Assessed up to 12 months |
|
Each participant was enrolled for roughly 3 months and was able to keep the glasses after that period.
The definitions did not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Weise | UAB | 2059752020 | kweise@uab.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2022 | Apr 10, 2022 | Prot_003.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D015835 | Ocular Motility Disorders |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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 |
| OG002 | 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 |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | prism diopters | Assessed up to 12 months |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|