Clinical trial NCT04297969: Hyperopia Detection GCK With Glow Fixation
Official title: Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia Bilateral
Hyperopia of Both Eyes
Astigmatism Bilateral
Accommodation Disorder
Lead sponsor: Alaska Blind Child Discovery
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 133
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a range of refractive errors including high hyperopia and astigmatism in a pediatric ophthalmology referral practice.

Brief summary: "GoCheck Kids" has added to its iPhone 7+ smart phone with flash concentrator a non-accommodating glow box fixation target. In pediatric eye patients, the "GCK" with glow box is compared to cycloplegic refraction as well as School Bus Accommodation-relaxing skiascopy, "2WIN" photoscreener and "Retinomax."

Detailed description: Patients undergoing comprehensive pediatric eye exam were screened with "GoCheck Kids" iPhone 7+ flash concentrated photoscreener with new, non-accommodating glow fixation target are well as "Adaptica 2WIN" photoscreener and "Retinomax" auto refraction all without drops before cycloplegia examination.

Reason for examination, visual acuity, ocular alignment and degree of amblyopia were specifically noted.

Refractive amblyopia risk factors utilizing "AAPOS 2003" and "AAPOS 2013" uniform guidelines were used to validate each screening method.

Patients for whom cycloplegia exam yielded at least 0.5 diopters hyperopia were compared to determine the ability of each screening tool to detect hyperopia.

Eligibility criteria: Inclusion Criteria:

* Patients having comprehensive pediatric eye examination

Exclusion Criteria:

* Patients with only one eye

Primary outcomes:
measure: 2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence
timeFrame: 1 week
Secondary outcomes:
measure: Amblyopia
timeFrame: 1 week
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's EYE & Strabismus
state: Alaska
Study officials:
References:
citation: Racano E, Alessi S, Pertile R. Comparison of 2Win and plusoptiX A12R refractometers with Retinomax handheld autorefractor keratometer. J AAPOS. 2019 Oct;23(5):276.e1-276.e5. doi: 10.1016/j.jaapos.2019.05.017. Epub 2019 Sep 17.
citation: Arnold SL, Arnold AW, Sprano JH, Arnold RW. Performance of the 2WIN Photoscreener With "CR" Strabismus Estimation in High-Risk Patients. Am J Ophthalmol. 2019 Nov;207:195-203. doi: 10.1016/j.ajo.2019.04.016. Epub 2019 May 9.
citation: Peterseim MMW, Rhodes RS, Patel RN, Wilson ME, Edmondson LE, Logan SA, Cheeseman EW, Shortridge E, Trivedi RH. Effectiveness of the GoCheck Kids Vision Screener in Detecting Amblyopia Risk Factors. Am J Ophthalmol. 2018 Mar;187:87-91. doi: 10.1016/j.ajo.2017.12.020. Epub 2018 Jan 2.
citation: Arnold RW, O'Neil JW, Cooper KL, Silbert DI, Donahue SP. Evaluation of a smartphone photoscreening app to detect refractive amblyopia risk factors in children aged 1-6 years. Clin Ophthalmol. 2018 Aug 23;12:1533-1537. doi: 10.2147/OPTH.S171935. eCollection 2018.
citation: Arnold RW, Arnold AW, Hunt-Smith TT, Grendahl RL, Winkle RK. The Positive Predictive Value of Smartphone Photoscreening in Pediatric Practices. J Pediatr Ophthalmol Strabismus. 2018 Nov 19;55(6):393-396. doi: 10.3928/01913913-20180710-01. Epub 2018 Aug 29.
citation: Levitt AH, Martin SJ, Arnold RW. Performance of Glow Fixation GoCheck Kids and 2WIN Photoscreeners and Retinomax to Uncover Hyperopia. Clin Ophthalmol. 2020 Aug 10;14:2237-2244. doi: 10.2147/OPTH.S256991. eCollection 2020.
citation: Arnold RW, Beveridge JS, Martin SJ, Beveridge NR, Metzger EJ, Smith KA. Grading Sphero-Cylinder Spectacle Similarity. Clin Optom (Auckl). 2021 Jan 20;13:23-32. doi: 10.2147/OPTO.S289770. eCollection 2021.