Wide-field digital imaging based telemedicine for screening for acute retinopathy of prematurity (ROP). Six-year results of a multicentre field study.
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SUBMITTER: Lorenz B
PROVIDER: S-EPMC2720584 | biostudies-other | 2009 Sep
REPOSITORIES: biostudies-other
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Project description:PurposeTo describe the clinical characteristics of intraocular hemorrhages (IOHs) in infants in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity (e-ROP) Study and to evaluate their potential use for prediction of disease severity.DesignSecondary data analysis from a prospective study.ParticipantsPreterm infants with birth weight (BW) ≤1250 g.MethodsInfants underwent serial digital retinal imaging in both eyes starting at 32 weeks' postmenstrual age. Nonphysician trained readers (TRs) evaluated all image sets from eyes that ever had IOHs documented on image evaluation or eye examination for the presence, location, type, area, and relation of the IOH to the junction between vascularized and avascular retina. Associations of IOH with demographic and neonatal factors, and with the presence and severity of retinopathy of prematurity (ROP) were investigated by univariate and multivariate analyses. Sensitivity and specificity of the telemedicine system for detecting referral-warranted ROP (RW-ROP) were calculated with and without incorporating hemorrhage into the standardized grading protocol.Main outcome measuresRetinal and vitreous hemorrhage.ResultsAmong 1239 infants (mean [standard deviation] BW = 864 [212] g; gestational age [GA] = 27 [2.2] weeks) who underwent an average of 3.2 imaging sessions, 22% had an IOH in an eye on at least 1 of the e-ROP visits. Classification of IOH was preretinal (57%), blot (57%), dot (38%), flame-shaped (16%), and vitreous (8%); most IOHs were unilateral (70%). The IOH resolved in 35% of eyes by the next imaging session and in the majority (76%) of cases by 8 weeks after initial detection. Presence of IOH was inversely associated with BW and GA and significantly associated (P < 0.0001) with the presence and severity of ROP (BW and GA adjusted odds ratios [ORs] of 2.46 for any ROP, 2.88 for stage 3, and 3.19 for RW-ROP). Incorporating IOH into the grading protocol minimally altered the sensitivity of the system (94% vs. 95%).ConclusionsApproximately 1 in 5 preterm infants examined had IOHs, generally unilateral. The presence of hemorrhage was directly correlated with both presence and severity of ROP and inversely correlated with BW and GA, although including hemorrhage in the grading algorithm only minimally improved the sensitivity of the telemedicine system to detect RW-ROP.
| S-EPMC5319900 | biostudies-literature
Project description:ImportanceMeasurable competence derived from comprehensive and advanced training in grading digital images is critical in studies using a reading center to evaluate retinal fundus images from infants at risk for retinopathy of prematurity (ROP). Details of certification for nonphysician trained readers (TRs) have not yet been described.ObjectiveTo describe a centralized system for grading ROP digital images by TRs in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity (e-ROP) Study.Design, setting, and participantsMulticenter observational cohort study conducted from July 1, 2010, to June 30, 2014. The TRs were trained by experienced ROP specialists and certified to detect ROP morphology in digital retinal images under supervision of an ophthalmologist reading center director. An ROP reading center was developed with standard hardware, secure Internet access, and customized image viewing software with an electronic grading form. A detailed protocol for grading was developed. Based on results of TR gradings, a computerized algorithm determined whether referral-warranted ROP (RW-ROP; defined as presence of plus disease, zone I ROP, and stage 3 or worse ROP) was present in digital images from infants with birth weight less than 1251 g enrolled from May 25, 2011, through October 31, 2013. Independent double grading was done by the TRs with adjudication of discrepant fields performed by the reading center director.ExposureDigital retinal images.Main outcomes and measuresIntragrader and intergrader variability and monitoring for temporal drift.ResultsFour TRs underwent rigorous training and certification. A total of 5520 image sets were double graded, with 24.5% requiring adjudication for at least 1 component of RW-ROP. For individual RW-ROP components, the adjudication rate was 3.9% for plus disease, 12.4% for zone I ROP, and 16.9% for stage 3 or worse ROP. The weighted κ for intergrader agreement (n = 80 image sets) was 0.72 (95% CI, 0.52-0.93) for RW-ROP, 0.57 (95% CI, 0.37-0.77) for plus disease, 0.43 (95% CI, 0.24-0.63) for zone I ROP, and 0.67 (95% CI, 0.47-0.88) for stage 3 or worse ROP. The weighted κ for grade-regrade agreement was 0.77 (95% CI, 0.57-0.97) for RW-ROP, 0.87 (95% CI, 0.67-1.00) for plus disease, 0.70 (95% CI, 0.51-0.90) for zone I ROP, and 0.77 (95% CI, 0.57-0.97) for stage 3 or worse ROP.Conclusions and relevanceThese data suggest that the e-ROP system for training and certifying nonphysicians to grade ROP images under the supervision of a reading center director reliably detects potentially serious ROP with good intragrader and intergrader consistency and minimal temporal drift.
| S-EPMC4910817 | biostudies-literature
Project description:PurposeTo develop a risk score for predicting treatment-requiring retinopathy of prematurity (TR-ROP) in the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity (e-ROP) study.DesignSecond analyses of an observational cohort study.ParticipantsInfants with birth weight (BW) <1251 g who had ≥1 imaging session by 34 weeks of postmenstrual age (PMA) and ≥1 subsequent retinopathy of prematurity (ROP) examination for determining TR-ROP by study-certified ophthalmologists.MethodsNonphysician trained readers evaluated wide-field retinal image sets for characteristics of ROP, pre-plus/plus disease, and retinal hemorrhage. Risk score points for predicting TR-ROP were derived from the regression coefficients of significant predictors in a multivariate logistic regression model.Main outcome measuresTR-ROP.ResultsEighty-five of 771 infants (11.0%) developed TR-ROP. In a multivariate model, significant predictors for TR-ROP were gestational age (GA) (odds ratio [OR], 5.7; 95% confidence interval [CI], 1.7-18.9 for ≤25 vs. ≥28 weeks), need for respiratory support (OR, 7.0; 95% CI, 1.3-37.1 for high-frequency oscillatory ventilation vs. no respiratory support), slow weight gain (OR, 2.4; 95% CI, 1.2-4.6 for weight gain ≤12 g/day vs. >15 g/day), and image findings at the first image session including number of quadrants with pre-plus (OR, 3.8; 95% CI, 1.5-9.7 for 4 pre-plus quadrants vs. no pre-plus), stage and zone of ROP (OR, 4.7; 95% CI, 2.1-11.8 for stage 1-2 zone I, OR, 5.9; 95% CI, 2.1-16.6 for stage 3 zone I vs. no ROP), and presence of blot hemorrhage (OR, 3.1; 95% CI, 1.4-6.7). Image findings predicted TR-ROP better than GA (area under receiver operating characteristic curve [AUC] = 0.82 vs. 0.75, P = 0.03). The risk of TR-ROP steadily increased with higher risk score and predicted TR-ROP well (AUC = 0.88; 95% CI, 0.85-0.92). Risk score ≥3 points for predicting TR-ROP had a sensitivity of 98.8%, specificity of 40.1%, and positive and negative predictive values of 17.0% and 99.6%, respectively.ConclusionsImage characteristics at 34 PMA weeks or earlier independently predict TR-ROP. If externally validated in other infants, risk score, calculated from image findings, GA, weight gain, and respiratory support, enables early identification of infants in need of increased surveillance for TR-ROP.
| S-EPMC5035617 | biostudies-literature
Project description:IMPORTANCE:Detection of treatment-requiring retinopathy of prematurity (ROP) involves serial eye examinations. An ROP prediction model using predictive factors could identify high-risk infants and reduce required eye examinations. OBJECTIVE:To determine predictive factors for the development of referral-warranted (RW) ROP. DESIGN, SETTING, AND PARTICIPANTS:This multicenter observational cohort study included secondary analysis of data from the Telemedicine Approaches to Evaluating Acute-Phase Retinopathy of Prematurity Study. Infants included in the study had a birth weight (BW) of less than 1251 g. EXPOSURES:Serial ROP examinations of premature infants who had 2 or more ROP examinations. MAIN OUTCOMES AND MEASURES:Incidence of RW-ROP (defined as the presence of plus disease, zone I ROP, or ROP stage 3 or greater in either eye) and associations with predictive factors. RESULTS:Among 979 infants without RW-ROP at first study-related eye examination (median postmenstrual age, 33 weeks; range, 29-40 weeks) who underwent at least 2 eye examinations, 149 (15.2%) developed RW-ROP. In a multivariate model, significant predictors for RW-ROP were male sex (odds ratio [OR], 1.80; 95% CI, 1.13-2.86 vs female), nonblack race (OR, 2.76; 95% CI, 1.50-5.08 for white vs black race and OR, 4.81; 95% CI, 2.19-10.6 for other vs black race), low BW (OR, 5.16; 95% CI, 1.12-7.20 for ?500 g vs >1100 g), younger gestational age (OR, 9.79; 95% CI, 3.49-27.5 for ?24 weeks vs ?28 weeks), number of quadrants with preplus disease (OR, 7.12; 95% CI, 2.53-20.1 for 1-2 quadrants and OR, 18.4; 95% CI, 4.28-79.4 for 3-4 quadrants vs no preplus disease), stage 2 ROP (OR, 4.13; 95% CI, 2.13-8.00 vs no ROP), the presence of retinal hemorrhage (OR, 4.36; 95% CI, 1.57-12.1 vs absence), the need for respiratory support (OR, 4.99; 95% CI, 1.89-13.2 for the need for controlled mechanical ventilator; OR, 11.0; 95% CI, 2.26-53.8 for the need for high-frequency oscillatory ventilation vs no respiratory support), and slow weight gain (OR, 2.44; 95% CI, 1.22-4.89 for weight gain ?12 g/d vs >18 g/d). These characteristics predicted the development of RW-ROP significantly better than BW and gestational age (area under receiver operating characteristic curve, 0.88 vs 0.78; P?<?.001). CONCLUSIONS AND RELEVANCE:When controlling for very low BW and prematurity, the presence of preplus disease, stage 2 ROP, retinal hemorrhage, and the need for ventilation at time of first study-related eye examination were strong independent predictors for RW-ROP. These predictors may help identify infants in need of timely eye examinations.
| S-EPMC4416963 | biostudies-literature
Project description:PurposeTo suggest a low cost, non-contact smartphone-based screening system in retinopathy of prematurity (ROP), and to illustrate its potential clinical application as a potential future tool for teleophthalmology.MethodsNeonatal intensive care unit (NICU)-based bedside ROP screening done between January 2018 and May 2018. Documentation of ROP was done by using a smartphone and +40D, +28D, or +20D indirect non-contact condensing lenses. By using the coaxial light source of the phone, this system works as an indirect ophthalmoscope that creates a digital image of the fundus. With smartphone-based camera we extracted high-quality still images extracted from the video clip.ResultsTotal of 228 eyes of 114 infants screened for ROP between January 2018 and May 2018. Incidence of total ROP was 23.68%, out of which incidence of type 1 ROP was 8.77%. After initial screening with indirect ophthalmoscope, we uesd smartphone imaging to document ROP in 28 eyes out of 55 eyes having ROP. Image quality was good in 89.28% eyes. Field of view vary from 46°, 53°, and 90° with +20D, +28D, and +40D indirect condensing lenses, respectively, which gives excellent images for bedside ROP documentation.ConclusionThe described technique of smartphone fundus photography is a light weight, cost-effective, user friendly, high-quality wide-field fundus photographs for bedside documentation of ROP in NICUs using readily available instruments that are handy and portable with simple power sources. Smartphones has the potential to be operated with only one hand. It can also be used as a future telescreening device.
| S-EPMC6552601 | biostudies-literature
Project description:To determine the symmetry on retinal image grading of fellow eyes for retinopathy of prematurity (ROP) features (stage, zone and plus disease) and severity, to provide the basis for the within subject comparison for ROP trials.Secondary analyses of data from the Telemedicine Approaches to Evaluating of Acute-Phase ROP (e-ROP) Study.Infants with birth weight less than 1251g.Infants underwent serial retinal imaging sessions in both eyes by certified imagers starting at 32-weeks postmenstrual age (PMA). Two trained non-physician readers graded each eye independently for ROP features in a 5 retinal-image set from each session. Discrepancies were adjudicated by a reading center supervisor. Readers were masked to all eye examination results, previous gradings of both eyes, current grading of the fellow eye, and demographic data.The inter-eye agreement assessed using percent exact agreement and weighted kappa (Kw ) for stage, zone, plus, referral-warranted ROP (RW-ROP, defined as presence of stage 3 or above, plus disease, or zone I ROP), and severity of ROP.Among 3918 image sessions in 1235 infants, the percent agreement (Kw ) between paired eyes was 75.3% (0.65) for stage of ROP, 82.3% (0.68) for zone of ROP, 78.7% (0.51) for plus disease, 84.7% (0.56) for RW-ROP, and 72.7% (0.63) for severity of ROP. Similar inter-eye agreements were found when considering ROP features at the first image session, at the last image session, at any image session. Based on image evaluations from all sessions, 412 (33.4%) infants had ROP stage 3 or above, 148 (12.0%) had zone I ROP, 70 (5.7%) had plus disease, and 419 (33.9%) had RW-ROP in one or both eyes; symmetrical findings were present in 71.4% for ROP stage 3 or above, 56.8% for zone I ROP, 50.0% for plus disease, and 73.7% for RW-ROP.Masked image evaluations by trained readers showed good inter-eye agreement in ROP characteristics, consistent with the high inter-eye agreement in ROP from clinical examinations by ophthalmologists in other studies. These data confirm that acute ROP is typically symmetrical and supports within subject comparison in ROP trials.
| S-EPMC5607452 | biostudies-literature
Project description:To report the training/certification process of nonphysician imagers, image quality, and factors that affected image quality in the National Eye Institute sponsored multicentered e-ROP study.Nonphysician imagers underwent rigorous training and certification in obtaining retinal images, with attention to clarity, focus, and optic disk placement. Image readers measured pupil size in pupil image and graded posterior pole, temporal, nasal, superior, and inferior retinal images and classified them as good, adequate, poor, or missing. Good and adequate images were deemed acceptable.In 4,003 image sessions of 1,257 infants, 3,453 (86.8%) were complete. Of 39,550 retinal images, 91.7% had acceptable quality, 5.6% poor, and 2.7% were missing. Inadequate pupil dilation negatively affected acceptable image quality: 54% acceptable images for pupil <5 mm versus 93% for >6 mm (P < 0.0001). When ventilatory equipment obstructed access to imaged infant, the percent of acceptable image quality decreased: 94% for no support versus 66.6% for oscillatory ventilation (P < 0.0001). Acceptable image quality rates improved from 87% to 90% (P = 0.03) from first 6 months to last 6 months at low patient volume centers, while high patient volume centers remained stable at 95%.Nonphysicians successfully obtained acceptable quality images for ROP evaluation. Skills improved with experience. Image quality was negatively affected by inadequate pupil dilation and the presence of obstructive ventilatory equipment.
| S-EPMC4936410 | biostudies-other
Project description:ImportanceThe current guidelines for retinopathy of prematurity (ROP) detection programs in the United States include a range of birth weights (BWs) and gestational ages and likely require examinations of many premature infants who are at low risk for developing serious retinopathy.ObjectiveTo determine the incidence, onset, and early course of ROP in what to our knowledge is the largest cohort to date that is representative of infants who are undergoing ROP screening.Design, setting, and participantsThis secondary analysis of data from the Postnatal Growth and Retinopathy of Prematurity (G-ROP) retrospective cohort study was conducted in 29 hospitals in the United States and Canada between January 2006 and December 2011 and included 7483 infants who underwent serial ROP examinations.Main outcomes and measuresMost severe ROP in either eye, classified as no ROP, mild ROP, type 2 ROP, or type 1 ROP (per Early Treatment for ROP Study criteria). Onset at postmenstrual age for zone I disease and stage of ROP, plus disease, and treatment.ResultsThis study included 7483 infants with a mean (SD) BW of 1099 (259) g and a mean (SD) gestational age of 28 (3) weeks who underwent ROP examinations. Of these, 3224 infants (43.1%) developed ROP, 459 (6.1%) developed type 1 and 472 (6.3%) type 2 ROP, 514 (6.9%) underwent treatment in 1 or both eyes, and 147 (2%) had zone I disease. Additionally, 98.1% of type 1 or 2 ROP cases occurred in infants with a BW of less than 1251 g. Only about half of the eyes (49.4%) were vascularized into zone III by 37 weeks postmenstrual age.Conclusions and relevanceThese findings add to our knowledge of ROP screening as they include all eligible infants, not just high-risk infants as in previous studies. More than 40% of at-risk premature infants develop some stage of ROP, and most retinopathy regresses without treatment. However, approximately 12.5% develop severe ROP, which occurs almost exclusively among infants with a BW of less than 1251 g.
| S-EPMC6583045 | biostudies-literature
Project description:To examine the feasibility of a retinopathy of prematurity (ROP) telemedicine evaluation system of providing timely feedback to a neonatal intensive care unit (NICU) with at-risk premature infants.This was a prospective observational study of premature infants with birth weights of <1251 g in five NICUs in the United States. Infants scheduled for clinically indicated ROP evaluations underwent indirect ophthalmoscopic examinations and digital imaging on the same day. Imaging was performed by nonphysician retinal imagers. Times required were determined from obtaining digital images of both eyes to submission via web-based system to a secure server for grading by trained readers at a central reading center to sending back grading results to the clinical center.A total of 1,642 image sets of eyes of 292 infants were obtained, from 823 imaging sessions. The mean turnaround time from submission of image sets of both eyes to return of the grading results to the clinical center was 10.1 ± 11.3 hours (standard deviation), with a median of 12.0 hours (1st quartile, 0.9 hours; 3rd quartile, 16 hours). Overall, 95.5% of gradings (95% CI, 93.9%-96.7%) were returned within 24 hours. Subgroup analyses found, for image sets submitted to the reading center before 2 p.m. Eastern Standard Time, median time to report was 1.7 hours (1st quartile, 0.7 hours; 3rd quartile, 15.5 hours) compared with those submitted after 2pm (median, 14.1 hours; 1st quartile, 11.2, hours; 3rd quartile, 16.3 hours).An ROP telemedicine approach can provide timely feedback to the NICU regarding the detection of potentially serious ROP and thus referral to an ophthalmologist for examination and consideration of treatment.
| S-EPMC5086263 | biostudies-literature
Project description:PurposeTo determine the incidence of and timing and predictors for progression from pre-plus to plus disease, based on evaluation of images.MethodsTwo trained readers independently evaluated posterior pole images of infants from 13 North American centers for pre-plus/plus disease, stage, and zone of retinopathy of prematurity (ROP). Discrepancies between readers were adjudicated. To be eligible for analysis, eyes had to have at least two imaging sessions, the earlier one with pre-plus disease.ResultsOf 681 eyes of 444 infants with pre-plus first detected at mean postmenstrual age (PMA) of 35.5 ± 2.1 weeks, 54 (7.9%) progressed to plus disease at a mean PMA of 37.6 ± 2.4 weeks with the mean interval for progression of 2.7 weeks (range, 0.4-8.9 weeks). Progression rate was higher for eyes with larger number of quadrants of pre-plus (44% for eyes with four quadrants vs 4% with one quadrant [P < 0.0001]), earlier PMA with pre-plus (18% for 32 weeks' PMA vs 3% for PMA of >37 weeks [P = 0.02]), higher ROP stage (12% for stage 3, 2.5% for no ROP [P < 0.0001]), lower ROP zone (24% for zone I, 6% for zone II or no ROP [P < 0.0001]) at the time of first pre-plus detection.ConclusionsBased on image evaluation, 8% of eyes progressed from pre-plus to plus disease at a mean interval of 3 weeks. Pre-plus in multiple quadrants, higher stages of ROP, and lower zones of ROP were associated with higher risk of progression. Image evaluation for pre-plus may help in the identification of high-risk eyes for developing plus disease.
| S-EPMC8005407 | biostudies-literature