Trial Outcomes & Findings for Spectacles Lens in Concussed Kids (NCT NCT03123822)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Assessed up to 12 months

Results posted on

2022-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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
Overall Study STARTED	1	1	3
Overall Study COMPLETED	1	1	3
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Vision Glasses n=1 Participants 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	Single Vision Glasses With Anti-glare Coating n=1 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	Eyezen n=3 Participants 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	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=1 Participants	1 Participants n=1 Participants	3 Participants n=3 Participants	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=3 Participants	0 Participants n=5 Participants
Age, Continuous	17 years n=1 Participants	14 years n=1 Participants	16 years n=3 Participants	16 years n=5 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=3 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants n=1 Participants	1 Participants n=3 Participants	1 Participants n=5 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Assessed up to 12 months

Population: All participants met the criteria of the study

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.

Outcome measures

Outcome measures
Measure	Single Vision Glasses n=1 Participants 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	Single Vision Glasses With Anti-glare Coating n=1 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	Eyezen n=1 Participants 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
Convergence Insufficiency Symptom Survey	29 score on a scale Standard Deviation 0	22 score on a scale Standard Deviation 0	14 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Single Vision Glasses n=1 Participants 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	Single Vision Glasses With Anti-glare Coating n=1 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	Eyezen n=1 Participants 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
Convergence Breaking Point at Near (Base Out Prism)	16 prism diopters Standard Deviation 0	40 prism diopters Standard Deviation 0	12 prism diopters Standard Deviation 0

Adverse Events

Single Vision Glasses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Vision Glasses With Anti-glare Coating

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Eyezen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Katherine Weise

UAB

Phone: 2059752020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place