ROP Check Premature Infant Outcomes
Conditions: Retinopathy of Prematurity (ROP)
Sponsor: Alaska Blind Child Discovery

COVER PAGE: 
Brief Title: ROP Check Database Premature Infant Outcomes 
NCT Number: not yet assigned 
Unique Protocol ID: ROPCHECK24 
Study Protocol and Statistical Analysis Plan 
 
This study has IRB review and does NOT require consent. 
Investigator: Robert W. Arnold, MD 
 
 

 
 
 
 
 
Observation trial of de-identified data from large ongoing US clinical dataset covering 
academic and private hospitals. 
Data reviewed concerning those infants who progressed to threshold for therapy (Type 1) 
and what type of therapy delivered. 
Statistics are typical descriptive statistics from database including median, interquartile 
range and percentages. 
These are analyzed with Mann-Whitney, Kruskal-Wallis and Chi Square. 
The workflow (encounter volume) for each infant is analyzed. 
The AAP guideline ROP screening criteria are evaluated in light of other recent proposals 
and compared to the ROP Check® dataset. 
 
“ROP Check® (NeoLight, LLC, Phoenix, Arizona) is a cloud-based electronic 
medical record (EMR) with built-in decision support used for ensuring ROP exams occur 
in a timely manner assisting neonatologists conform to complex screening guidelines, and 
for ophthalmologist tracking ROP staging exams and treatment. We use a de-identified 
data set of examination results from 28 hospitals which employed the software from 2010 
through 2022. The acuity level of the neonatal intensive care units (NICUs) is as follows: 
four Level 4 NICUs, six Level 3B NICUs, twelve Level 3 NICUs, and six Level 2 NICUs 
and included both academic and non-academic centers. The American Academy of 
Pediatrics ROP guidelines recommend all infants less than 31 weeks gestational age (“a 
gestational age of 30 or less [completed weeks] (as defined by the neonatologist”) require 

ROP staging exams1. Surviving infants with birth gestational age of 21+6 weeks to 30+6 
weeks are included in the analysis. IRB exemption (45 CFR § 46.104(d)(4),) was obtained 
for using the de-identified data set from WCG IRB on 3/4/24.  The study complies with 
the Declaration of Helsinki and the Health Insurance Portability and Accountability Act 
(HIPAA).  Hospitals initiated the use of the program at different years.  The infant’s race 
is diagnosed by the neonatologist was recorded by NICU clinical staff. 
Patient demographic characteristic data, such as birthweight and gestational age, 
and details of numbers and timing of recorded encounters (either examinations or 
treatments) in ROP Check® are analyzed for non-normal distribution by Shapiro Wilk test 
before non-parametric analysis. 
Recently proposed alterations to the AAP screening guidelines have been 
published but until now, not yet compared with a North American cohort of premature 
infants with substantial numbers of infants of Pacific races that are at high risk for 
treatment-warranted ROP2-5.” 
Compared study cohorts 
  
ROP Check® from 2010 to 2022 
Study 
Years 
patients 
BW> 
GA> 
1st 
exam? 
miss
? 
  
missed
? 
Avoid
? 
Cohor
t 
Trea
t 
%Tx 
Tx GA 
%RO
P 
Pacifi
c 
E-ROP 
2004-
22 
1257 of 
6729 
750 
27 
37 wk 
1 
  
4 
2.0% 
2975 
32 
1.1
% 
33.
6 
41.
6 
80% 
15% 
First-ROP 
2017-
23 
1125 of 
2004 
800 
27 
34 wk 
0 
  
4 
8.6% 
2917 
29 
1.0
% 
33.
6 
41.
6 
80% 
47% 
Moir + 
2003-
22 
6025 of 
8364 
100
0 
29 
31-34 wk 
0 
  
4 
3.1% 
1543 
4 
0.3
% 
36.
1 
37.
9 
90% 
50% 
SCREEN-
ROP 
2016-
24 
61 of 823 
120
0 
30 
31-34 wk 
0 
  
2 
"7.6%
" 
625 
2 
0.3
% 
37.
5 
37.
7 
94% 
22% 
TWO-ROP 
2013-
23 
1095 of 
3239 
150
0 
30 
38-9 wk 
0 
  
3 
2.2% 
989 
3 
0.3
% 
37.
5 
37.
9 
91% 
21% 
ROP Check® 
5058 
387 
7.7
% 
29.
1 
47.
7 
59% 
13% 
"30+4" 
2010-
22 
287 of 5058 
any 
30+
4 
31-34 wk 
na 
  
0 
2.5% 
287 
0 
0.0
% 
na 
na 
93% 
25% 

ROP-if-P 
2010-
22 
957 of 5058 
140
0 
30 
31-34 wk 
na 
  
0 
7.90% 
957 
0 
0.0
% 
na 
na 
92% 
0% 
 
 
References: 
1. 
Fierson WM, Ophthalmology AAOPSo, American Academy Of O, American 
Association For Pediatric O, Strabismus, American Association Of Certified O. Screening 
Examination of Premature Infants for Retinopathy of Prematurity. Pediatrics. Dec 
2018;142(6)doi:10.1542/peds.2018-3061 
2. 
Jacob J, Arnold RW. The characteristics of racial disparity in retinopathy of 
prematurity outcomes. J Perinatol. jul 18 2025;45:In Press. doi:10.1038/s41372-025-02355-
5 
3. 
Jacob J, Matrix Z, Skopec D, Ticho BH, Arnold RW. Factors associated with 
retinopathy of prematurity ophthalmology workload. J Perinatology. Received: 3 April 2018 / 
Accepted: 8 August 2018 2018;38:1588-1593. doi:https://doi.org/10.1038/s41372-018-
0212-x 
4. 
Arnold RW, Jacob J, Matrix Z. Toward Achieving 100% Adherence for Retinopathy of 
Prematurity Screening Guidelines. J Pediatr Ophthalmol Strabismus. Nov 1 2017;54(6):356-
362. doi:10.3928/01913913-20170329-04 
5. 
Lang DM, Blackledge J, Arnold RW. Is Pacific race a retinopathy of prematurity risk 
factor? Arch Pediatr Adolesc Med. Aug 2005;159(8):771-3. doi:159/8/771 [pii] 
10.1001/archpedi.159.8.771