Hyperopia Detection GCK With Glow Fixation

NCT ID: NCT04297969

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-14

Study Completion Date

2020-03-03

Brief Summary

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"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

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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.

Conditions

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Amblyopia Bilateral Hyperopia of Both Eyes Astigmatism Bilateral Accommodation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GCK Glow fixation

Patients screened with GoCheck Kids flash concentrated iPhone 7+

objective pediatric vision screen "GCK glow fixation"

Intervention Type DIAGNOSTIC_TEST

2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device

Interventions

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objective pediatric vision screen "GCK glow fixation"

2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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objective pediatric vision screening GCK glow fixation

Eligibility Criteria

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Inclusion Criteria

* Patients having comprehensive pediatric eye examination

Exclusion Criteria

* Patients with only one eye
Minimum Eligible Age

1 Month

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alaska Blind Child Discovery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alaska Children's EYE & Strabismus

Anchorage, Alaska, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31539614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31077668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29305313 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30197499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30160295 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32982148 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33505178 (View on PubMed)

Other Identifiers

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ABCD GCK Glow

Identifier Type: -

Identifier Source: org_study_id

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