Hyperopia Detection GCK With Glow Fixation

Astigmatism Bilateral Clinical Trial

Official title:

Detection of Hyperopia by Photoscreener GoCheckKids With Glow Fixation Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04297969
• Other study ID #: ABCD GCK Glow
• Status: Completed
• Start date: October 14, 2019
• Est. completion date: March 3, 2020

Study information

• Verified date: March 2020
• Source: Alaska Blind Child Discovery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 3, 2020
• Est. primary completion date: November 6, 2019
• Gender: All
• Age group: 1 Month to 20 Years

Eligibility

Inclusion Criteria:

• Patients having comprehensive pediatric eye examination

Exclusion Criteria:

• Patients with only one eye

Related Conditions & MeSH terms

• Accommodation Disorder
• Amblyopia
• Amblyopia Bilateral
• Astigmatism
• Astigmatism Bilateral
• Hyperopia
• Hyperopia of Both Eyes

Intervention

Diagnostic Test:
• objective pediatric vision screen "GCK glow fixation"
2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device

Locations

Country	Name	City	State
United States	Alaska Children's EYE & Strabismus	Anchorage	Alaska

Sponsors (1)

Lead Sponsor	Collaborator
Alaska Blind Child Discovery

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2003 and 2013 AAPOS Uniform Amblyopia Risk Factor (ARF) prevalence	presence of refractive risk factors (anisometropia >1.50D, hyperopia > 3.5D, Astigmatism >1.50D, myopia more than 3D	1 week
Secondary	Amblyopia	Presence of amblyopia defined by decreased visual acuity with normal anatomy plus amblyopia risk factors.	1 week