Robert Jackson Hardy died on April 11, 2021, after a brief illness. He was born in 1940 in Alexandria, Louisiana. He is survived by his wife of 57 years, Lydia Waguespack Hardy. Robert and Lydia, lately of San Antonio, Texas, resided for almost 40 years in Missouri City, Texas. He is also survived by his daughters and their families and a large, extended family to whom he was extremely devoted.

AMD and this variant in other ethnic groups, and thus the possibility for systemic errors in other groups, remains largely unexplored. As our results highlight, predictive genetic testing for complex diseases faces many challenges. Until we fully understand how a particular genetic variant acts on disease susceptibility, great care must be taken when translating genetic tests from one race-ethnicity to another.

OBJECTIVE To compare monocular visual field extent at 6 years of age in eyes with high-risk prethreshold retinopathy of prematurity (ROP) randomized to early treatment (ET) with eyes that underwent conventional management (CM) and were treated at threshold or regressed without treatment. METHODS Subjects were 370 surviving study participants who developed high-risk prethreshold ROP and were enrolled in the Early Treatment for Retinopathy of Prematurity Study between October 1, 2000, and September 30, 2002. When the participants were 6 years of age, vision testers unaware of ROP status used white-sphere kinetic perimetry to measure visual field extent along the superotemporal, inferotemporal, inferonasal, and superonasal meridians. RESULTS The extent of the visual field was 0.1° to 3.7° larger in ET eyes when blind eyes were assigned a score of 0°. When data were examined from eyes of participants with 1 sighted ET eye and 1 sighted CM eye, ET eyes showed a small (1.3°-3.1°) reduction, which was statistically significant only along the superonasal meridian (P = .005). In bilaterally sighted children, visual field extent was not significantly reduced for high-risk type 1 ET eyes (-0.9° to 1.8°). However, in ET eyes with high-risk type 2 disease, visual field extent was significantly smaller compared with that of CM eyes (3.6°-8.7° superonasal field [P = .003]; inferonasal field [P < .001]). CONCLUSION Early treatment preserves peripheral vision, with only a small reduction of visual field extent. APPLICATION TO CLINICAL PRACTICE Early treatment for high-risk prethreshold ROP does not adversely affect visual field extent clinically.

Purpose: To describe patient characteristics, classification, and onset of prethreshold retinopathy of prematurity (ROP), and ocular findings at 6 months corrected age in infants with birth weights <500 g who were enrolled in the Early Treatment for Retinopathy of Prematurity (ETROP) Study.Design: Multicenter randomized clinical trial.Participants: Sixty-three infants with birth weights <500 g who developed ROP and were enrolled in the ETROP Study.Methods: Infants <1251 g at birth were logged at 26 study centers from October 1, 2000, to September 30, 2002, and underwent examinations for ROP. Infants who developed ROP and whose parents/legal guardians consented were enrolled in the ETROP Study. Infants who developed high-risk prethreshold ROP were randomized; 1 eye was treated early with peripheral retinal ablation and the other eye was managed conventionally, or, in asymmetric cases, the high-risk eye was randomized to early peripheral retinal ablation or conventional management. All eyes reaching prethreshold ROP were examined when infants reached 6 months corrected age.Main Outcome Measures: Retinopathy of prematurity incidence, characteristics, and ocular findings among participants.Results: Thirty-four infants reached prethreshold or worse severity in 1 or both eyes. Retinopathy of prematurity was located in zone I in 43.3% of all prethreshold eyes, and plus disease was present in 46.7%. Median postmenstrual age for diagnosis of all prethreshold ROP was 36.1 weeks, but earlier (35.1 weeks) for eyes that developed high-risk prethreshold ROP. In the 27 surviving infants with prethreshold ROP, ophthalmic examination at 6 months corrected age showed a normal posterior pole in 22 (81.5%), a favorable structural outcome with posterior pole abnormalities in 4 (14.8%), and an unfavorable structural outcome (stage 4B) in 1 (3.7%). One infant developed amblyopia, 4 infants developed nystagmus, 4 infants developed strabismus, and 8 infants developed myopia >-5.00 diopters.Conclusions: This is the first report on characteristics of prethreshold ROP in infants with birth weights <500 g. These infants are at high risk for developing prethreshold ROP, although many initially achieve a favorable structural outcome. They are at risk of developing strabismus, nystagmus, high myopia, and abnormal retinal structure and should therefore receive continued long-term follow-up.Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2011; 118: 1145-1151 (C) 2011 by the American Academy of Ophthalmology.

PURPOSE To present strabismus data for children who participated in the Early Treatment for Retinopathy of Prematurity (ETROP) randomized trial.METHODS The prevalence of strabismus, categorized as present or absent, was tabulated for all children with history of high-risk prethreshold retinopathy of prematurity (ROP) who participated in the ETROP randomized trial and were examined at 9 months to 6 years of age. Relationships among strabismus and demographic measures, eye characteristics, and neurodevelopmental factors were analyzed.RESULTS Among the 342 children evaluated at 6 years, the prevalence of strabismus was 42.2%. Even with favorable acuity scores in both eyes, the prevalence of strabismus was 25.4%, and with favorable structural outcomes in both eyes the prevalence of strabismus was 34.2%. Of children categorized as visually impaired as the result of either ocular or cerebral causes, 80% were strabismic at the 6-year examination. Of 103 study participants who were strabismic at 9 months, 77 (74.8%) remained so at 6 years. Most strabismus was constant at both the 9-month (62.7%) and the 6-year examination (72.3%). After multiple logistic regression analysis, risk factors for strabismus were abnormal fixation behavior in one or both eyes (P < 0.001), history of amblyopia (P < 0.003), unfavorable structural outcome in one or both eyes (P = 0.025), and history of anisometropia (P = 0.04). Strabismus surgery was performed for 53 children. By 6 years, the cumulative prevalence of strabismus was 59.4%.CONCLUSIONS Most children with a history of high-risk prethreshold ROP develop strabismus at some time during the first 6 years of life. (J AAPOS 2011;15:536-540)

In this workshop, the findings from the Early Treatment for Retinopathy of Prematurity Study (ETROP) will be reviewed, explained, and discussed. Dr. Good will begin with an overview of the study, factors that were considered at the study's inception, and major findings of the study. Dr. Hardy will review statistical methods used to determine findings. Drs. Davitt and Quinn will discuss refractive error changes noted in the ETROP Study, and how these compare with the CRYO-ROP Study. Dr. Quinn will review ICROP findings that are relevant to the ETROP Study. Dr. Phelps will discuss the neonatologist's perspective, and also compare the ETROP Study to other ROP clinical trials. Dr. Palmer will discuss significant findings from the CRYO-ROP Study and how these compare with the ETROP Study. At the conclusion, the panel will look forward to discuss further analyses underway in the ETROP Study. We expect a vigorous debate on the subject of plus disease and the future of photoscreening, as it may pertain to findings from the ETROP Study. The audience will have the opportunity to interact with the panel to review study methodology and findings.

OBJECTIVETo compare grating (resolution) visual acuity at 6 years of age in eyes that received early treatment (ET) for high-risk prethreshold retinopathy of prematurity (ROP) with that in eyes that underwent conventional management (CM).METHODSIn a randomized clinical trial, infants with bilateral, high-risk prethreshold ROP (n = 317) had one eye undergo ET and the other eye undergo CM, with treatment only if ROP progressed to threshold severity. For asymmetric cases (n = 84), the high-risk prethreshold eye was randomized to ET or CM.MAIN OUTCOME MEASUREGrating visual acuity measured at 6 years of age by masked testers using Teller acuity cards.RESULTSMonocular grating acuity results were obtained from 317 of 370 surviving children (85.6%). Analysis of grating acuity results for all study participants with high-risk prethreshold ROP showed no statistically significant overall benefit of ET (18.1% vs 22.8% unfavorable outcomes; P = .08). When the 6-year grating acuity results were analyzed according to a clinical algorithm (high-risk types 1 and 2 prethreshold ROP), a benefit was seen in type 1 eyes (16.4% vs 25.2%; P = .004) undergoing ET, but not in type 2 eyes (21.3% vs 15.9%; P = .29).CONCLUSIONEarly treatment of eyes with type 1 ROP improves grating acuity outcomes, but ET for eyes with type 2 ROP does not. APPLICATION TO CLINICAL MEDICINE: Type 1 eyes should be treated early; however, based on acuity results at 6 years of age, type 2 eyes should be cautiously monitored for progression to type 1 ROP. Trial Registration clinicaltrials.gov Identifier: NCT00027222.

Most ophthalmologists examining infants with retinopathy of prematurity (ROP) are familiar with the International Classification of ROP and its revision, the usual appearance of the disease, and standard treatment recommendations. However, examiners sometimes encounter cases in which the morphology varies from its typical appearance. In these cases, it can be difficult to determine the significance of these findings and to decide when treatment is indicated. In this fast-paced workshop, each moderator will present several cases representing dilemmas in ROP diagnosis and/or management, such as the presence or absence of plus disease and preplus disease, the optimal timing of laser treatment and retreatment, subtle signs of early disease regression, and appropriate follow-up intervals. Video clips captured during indirect ophthalmoscopy or Retcam images will be used to illustrate cases. An expert panel, including Earl Palmer, MD, Graham Quinn, MD, and Richard Saunders, MD, will comment on pertinent findings and their significance. Controversy surrounding recent changes in recommended screening criteria will also be addressed. Audience participation through questions and discussion will be encouraged. After viewing many examples of disease morphology, the attendants of the workshop will be more prepared to make treatment and follow-up recommendations for infants with ROP.

PURPOSE:To describe clinical features of patients from the Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) trial who, after developing severe ROP in infancy, had minimal or moderate retinal residua in at least one eye but a visual acuity of worse than 20/200 in both eyes at the 10 year examination. METHODS:Data from the 10 year CRYO-ROP Trial follow-up exams were evaluated to identify all patients with retinal outcomes of no retinopathy of prematurity (ROP) residua, straightened temporal vessels, or macular heterotopia in at least one eye, but visual acuity less than 20/200 in both eyes. Presence of optic atrophy, nystagmus, and optic disk cupping and developmental survey results were examined. RESULTS:Of 247 patients examined at 10 years, 16 met our inclusion criteria. At the last age at which the following data were recorded, seven had optic atrophy at the 10 year examination, one had optic disk cupping >0.5 at the 5(1/2) year examination, and eight had nystagmus under binocular conditions at the 24 month examination. Nine patients had a below-normal developmental test score on the Functional Independence Measure for Children (WeeFIM). After clinical data interpretation, we concluded that the predominant cause of visual impairment was postgeniculate disease in five patients, ROP in six patients, and combined anterior and posterior visual pathway disease in two patients; in three patients data were insufficient to make a determination. CONCLUSIONS:Poor visual function with mild to moderate retinal residua of severe ROP in at least one eye is relatively rare. In such patients, anterior, posterior, or combined visual pathway disease can occur.

OBJECTIVE:To report the ocular structure and visual acuity outcomes at age 15 years, and the incidence of retinal detachment between 10 and 15 years of age, for patients in the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP).METHODS:Subjects were 254 survivors from 291 preterm children with birth weights less than 1251 g and severe (threshold) retinopathy of prematurity (ROP) in one or both eyes, who participated in the CRYO-ROP trial. At age 15 years, unfavorable ocular structure was posterior retinal fold or worse judged by study-certified ophthalmologists. Unfavorable distance visual acuity was 20/200 or worse measured by study-certified testers using Early Treatment of Diabetic Retinopathy Study recognition acuity charts.RESULTS:Thirty percent of treated eyes and 51.9% of control eyes (P<.001) had unfavorable structural outcomes. Between 10 and 15 years of age, new retinal folds, detachments, or obscuring of the view of the posterior pole occurred in 4.5% of treated and 7.7% of control eyes. Unfavorable visual acuity outcomes were found in 44.7% of treated and 64.3% of control eyes (P<.001).CONCLUSION:The benefit of cryotherapy for treatment of threshold ROP, for both structure and visual function, was maintained across 15 years of follow-up. New retinal detachments, even in eyes with relatively good structural findings at age 10 years, suggest value in long-term, regular follow-up of eyes that experience threshold ROP.

OBJECTIVE:To determine whether earlier treatment of high-risk, prethreshold retinopathy of prematurity (ROP) improves retinal structural outcome at 2 years of age.METHODS:Infants with bilateral high-risk prethreshold ROP had one eye randomly assigned to treatment with peripheral retinal ablation. The fellow eye was managed conventionally, and either treated at threshold ROP or observed if threshold was never reached. In patients with asymmetrical disease, the high-risk, prethreshold eye was randomised to earlier treatment or to conventional management. At 2 years of age, children were examined comprehensively by certified ophthalmologists to determine structural outcomes for their eyes. For the purposes of this study, an unfavourable structural outcome was defined as (1) a posterior retinal fold involving the macula, (2) a retinal detachment involving the macula or (3) retrolental tissue or "mass" obscuring the view of the posterior pole. Results of the 2-year examination were compared with those from the 9 months examination.RESULTS:Data were available on 339 of 374 (90.6%) surviving children. Unfavourable structural outcomes were reduced from 15.4% in conventionally managed eyes to 9.1% in earlier-treated eyes (p = 0.002) at 2 years of age. Ophthalmic side effects (excluding retinal structure) from the ROP or its treatment were similar in the earlier-treated eyes and the conventionally managed eyes.CONCLUSION:The benefit of earlier treatment of high-risk prethreshold ROP on retinal structure endures to 2 years of age, and is not counterbalanced by any known side effect caused by earlier intervention. Earlier treatment improves the chance for long-term favourable retinal structural outcome in eyes with high-risk prethreshold ROP. Long-term follow-up is planned to determine structural and functional outcomes at 6 years of age.

PURPOSE:To analyze and discuss the relationship between the factor of time and our understanding of retinopathy of prematurity (ROP).METHODS:The author calls upon 30 years of experience in clinical investigations of ROP to critically synthesize selected literature on ROP, with attention to the broad theme of time. Future opportunities for clinical research are also considered.RESULTS:Although retinopathy of prematurity (ROP) ultimately is self-limited in its course, it is highly variable in its severity and outcome. Both the CRYO-ROP and the ETROP studies paid close attention to the chronology of ROP events; however, they approached the question of when to randomize eyes for treatment not simply according to a time definition, but rather according to disease severity characteristics. Still, results of both these studies can be reviewed from a time perspective, and indeed the pace of progression was one of the risk variables considered for ETROP randomization. The optimal schedule under which to perform eye examinations for active ROP is changing, as our understanding of this disease continues to improve.DISCUSSION:The factor of time is interwoven throughout the clinical course of ROP. Randomized clinical trials have proven to be an extremely efficient scientific method of comparing alternative treatment strategies. In looking toward the future, further randomized clinical trials are needed to investigate rational clinical management of cases in which retinal ablative therapy fails to arrest ROP's progression.

Objective: To present strabismus data for premature infants with prethreshold retinopathy of prematurity (ROP) enrolled in the Early Treatment for Retinopathy of Prematurity study.Design: The prevalence of strabismus was tabulated for all of the infants with high-risk prethreshold disease who participated in the randomized trial of the Early Treatment for Retinopathy of Prematurity study and were examined at 6 and/or 9 months' corrected age as well as for all of the infants with low-risk prethreshold disease who were examined at 6 months' corrected age.Main Outcome Measures: Presence or absence of strabismus at 6 and 9 months' corrected age.Results: The prevalence of strabismus at 6 months was higher for infants with high-risk prethreshold ROP than for those with low-risk prethreshold ROP (20.3% vs 9.6%, respectively; P < .001). Risk factors associated with the development of strabismus at 9 months include abnormal fixation behavior, presence of amblyopia, and outborn birth status (ie, born outside of a study-affiliated hospital). At 9 months, 30% of infants with high-risk prethreshold ROP had strabismus, although only 42% showed strabismus at 6 months. Thirty percent of infants with strabismus at 6 months showed normal alignment at 9 months.Conclusions: Infants with high-risk prethreshold ROP show significant variability in the presence vs absence of strabismus in the first year of life; thus, conservative management is recommended.Application to Clinical Practice: Ophthalmologists managing strabismus in infants who have high-risk prethreshold ROP should be aware of the significant variability in ocular alignment during the first year of life.

PURPOSE To analyze and discuss the relationship between the factor of time and our understanding of retinopathy of prematurity (ROP).METHODS The author calls upon 30 years of experience in clinical investigations of ROP to critically synthesize selected literature on ROP, with attention to the broad theme of time. Future opportunities for clinical research are also considered.RESULTS Although retinopathy of prematurity (ROP) ultimately is self-limited in its course, it is highly variable in its severity and outcome. Both the CRYO-ROP and the ETROP studies paid close attention to the chronology of ROP events; however, they approached the question of when to randomize eyes for treatment not simply according to a time definition, but rather according to disease severity characteristics. Still, results of both these studies can be reviewed from a time perspective, and indeed the pace of progression was one of the risk variables considered for ETROP randomization. The optimal schedule under which to perform eye examinations for active ROP is changing, as our understanding of this disease continues to improve.DISCUSSION The factor of time is interwoven throughout the clinical course of ROP. Randomized clinical trials have proven to be an extremely efficient scientific method of comparing alternative treatment strategies. In looking toward the future, further randomized clinical trials are needed to investigate rational clinical management of cases in which retinal ablative therapy fails to arrest ROP's progression.

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