Spectacles Lens in Concussed Kids

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.

• Glasses (Device): Glasses traditionally prescribed for refractive error

Primary outcomes

• 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 outcomes

• 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.

Sex: All, ages: 9 Years to 17 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Convergence Insufficiency Symptom Survey (Primary), Mean, score on a scale: Single Vision Glasses 29 +/- 0; Single Vision Glasses With Anti-glare Coating 22 +/- 0; Eyezen 14 +/- 0
• Convergence Breaking Point at Near (Base Out Prism) (Secondary), Mean, prism diopters: Single Vision Glasses 16 +/- 0; Single Vision Glasses With Anti-glare Coating 40 +/- 0; Eyezen 12 +/- 0

Adverse events

Time frame: Each participant was enrolled for roughly 3 months and was able to keep the glasses after that period.

• Study Protocol (PDF, 2022-04-02)

• Becky Luu, OD, Study director, University of Alabama at Birmingham
• Katherine Weise, OD, Principal investigator, University of Alabama at Birmingham