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1.
J AAPOS ; 27(1): 10.e1-10.e8, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36681111

RESUMEN

PURPOSE: To report 2-year ocular and developmental outcomes for infants receiving low doses of intravitreal bevacizumab for type 1 retinopathy of prematurity (ROP). METHODS: A total of 120 premature infants (mean birthweight, 687 g; mean gestational age, 24.8 weeks) with type 1 ROP were enrolled in a multicenter, phase 1 dose de-escalation study. One eye per infant received 0.25 mg, 0.125 mg, 0.063 mg, 0.031 mg, 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreal bevacizumab; fellow eyes when treated received one dosage level higher. At 2 years, 70 of 120 children (58%) underwent ocular examinations; 51 (43%) were assessed using the Bayley Scale of Infant and Toddler Development. RESULTS: Correlation coefficients for the association of total dosage of bevacizumab with Bayley subscales were -0.20 for cognitive (95% CI, -0.45 to 0.08), -0.15 for motor (95% CI, -0.41 to 0.14), and -0.19 for language (95% CI, -0.44 to 0.10). Fourteen children (21%) had myopia greater than -5.00 D in one or both eyes, 7 (10%) had optic nerve atrophy and/or cupping, 20 (29%) had strabismus, 8 (11%) had manifest nystagmus, and 9 (13%) had amblyopia. CONCLUSIONS: In this study cohort, there was no statistically significant correlation between dosage of bevacizumab and Bayley scores at 2 years. However, the sample size was small and the retention rate relatively low, limiting our conclusions. Rates of high myopia and ocular abnormalities do not differ from those reported after larger bevacizumab doses.


Asunto(s)
Miopía , Retinopatía de la Prematuridad , Recién Nacido , Lactante , Humanos , Bevacizumab/uso terapéutico , Retinopatía de la Prematuridad/tratamiento farmacológico , Inhibidores de la Angiogénesis/uso terapéutico , Factor A de Crecimiento Endotelial Vascular , Edad Gestacional , Inyecciones Intravítreas , Estudios Retrospectivos
5.
J AAPOS ; 26(2): 66.e1-66.e4, 2022 04.
Artículo en Inglés | MEDLINE | ID: mdl-35158048

RESUMEN

BACKGROUND: Application of current retinopathy of prematurity (ROP) screening criteria results in many unnecessary examinations, because only 5%-10% of infants screened require treatment. Application of screening criteria established by the Postnatal Growth and Retinopathy of Prematurity Study could significantly reduce unnecessary examinations without sacrificing sensitivity to detect treatment-requiring ROP. We evaluated the performance of the G-ROP criteria in a population of high-risk, outborn infants. METHODS: The medical records of consecutive infants screened and/or treated for ROP at Children's Health Care of Atlanta Hospitals from May 1, 2013, to September 6, 2019, were reviewed retrospectively. The sensitivity of the G-ROP birthweight and gestational age screening criteria to detect treatment-requiring ROP was calculated. RESULTS: During the study period, 901 children underwent examinations for ROP; of these, 5 were excluded from the analysis because birth weight (BW) data was lacking. Of the 896 remaining patients, 120 patients were treated for ROP. Application of G-ROP birth weight and gestational age (GA) criteria alone resulted in a sensitivity of 99.2% to detect infants requiring treatment. Application of weight gain criteria was problematic, because many patients were transferred into our institutions after the specified intervals of 10-19, 20-29, and 30-39 days. CONCLUSIONS: G-ROP BW and GA screening criteria were highly sensitive in detecting treatment-requiring ROP. Applying weight gain criteria in referral centers can be problematic. Intake procedures at referral centers should include documentation of weight gain during 10-19, 20-29, and 30-39 days of life.


Asunto(s)
Retinopatía de la Prematuridad , Peso al Nacer , Niño , Edad Gestacional , Humanos , Lactante , Recién Nacido , Tamizaje Neonatal , Retinopatía de la Prematuridad/diagnóstico , Retinopatía de la Prematuridad/epidemiología , Retinopatía de la Prematuridad/terapia , Estudios Retrospectivos , Factores de Riesgo , Centros de Atención Terciaria , Aumento de Peso
6.
J AAPOS ; 26(1): 1.e1-1.e6, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-35066152

RESUMEN

BACKGROUND: As instrument-based pediatric vision screening technology has evolved, the American Association for Pediatric Ophthalmology and Strabismus (AAPOS) has developed uniform guidelines (2003, updated 2013) to inform the development of devices that can detect specified target levels of amblyopia risk factors (ARFs) and visually significant refractive error. Clinical experience with the established guidelines has revealed an apparent high level of over-referral for non-amblyopic, symmetric astigmatism, prompting the current revision. METHODS: The revised guidelines reflect the expert consensus of the AAPOS Vision Screening and Research Committees. RESULTS: For studies of automated screening devices, AAPOS in 2021 recommends that the gold-standard confirmatory comprehensive examination failure levels include anisometropia >1.25 D and hyperopia >4.0 D. Astigmatism >3.0 D in any meridian and myopia < -3 D should be detected in children <48 months, whereas astigmatism >1.75 D and myopia < -2 D should be detected after 48 months. Any media opacity >1 mm and manifest strabismus of >8Δ should also be identified. Along with performance in detecting ARFs and refractive error, validation studies should also report screening instrument performance with regard to presence or absence of amblyopia. Instrument receiver operating characteristic curves and Bland-Altman analysis are suggested to improve comparability of validation studies. CONCLUSIONS: Examination failure criteria have been simplified and the threshold for symmetric astigmatism raised compared to the 2013 guidelines, whereas the threshold for amblyogenic anisometropia has been decreased. After age 4 years, lower magnitudes of symmetric astigmatism and myopia are also targeted despite a low risk of amblyopia, because they can influence school performance and may warrant consideration of myopia prevention therapy.


Asunto(s)
Ambliopía , Anisometropía , Hiperopía , Errores de Refracción , Selección Visual , Ambliopía/diagnóstico , Anisometropía/diagnóstico , Niño , Preescolar , Humanos , Hiperopía/diagnóstico , Errores de Refracción/diagnóstico
7.
Retina ; 41(11): 2269-2277, 2021 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-34190725

RESUMEN

PURPOSE: To describe characteristics and outcomes of patients with retinopathy of prematurity who failed intravitreal antivascular endothelial growth factor. METHODS: A retrospective case series of 211 eyes (112 patients) treated with antivascular endothelial growth factor as initial therapy for retinopathy of prematurity at a single academic institution between 2011 and 2019 and an additional 6 eyes (3 patients) referred to us for management of failed antivascular endothelial growth factor. RESULTS: Among the 211 eyes receiving initial treatment at our institution, 17 eyes (11%) failed. Of the 23 total eyes managed by us for failure, 3 eyes (13%) failed after 50-week postmenstrual age. Failure manifested as recurrent plus in 14 eyes (58%), recurrent Stage 3 in 13 eyes (54%) and retinal detachment in 5 eyes (21%). Treatment failures were managed with laser (13 eyes), repeat injection (4 eyes), vitrectomy (2 eyes), or a combination of modalities (4 eyes). Follow-up of ≥6 months was available for 18 of the 23 eyes. The retina was fully attached in 17 eyes, and fixation behavior was present in 10 eyes. CONCLUSION: The most common manifestations of treatment failure were recurrent plus and Stage 3. The failure rate at our institution was 11.0%. A significant proportion of failures occurred after 50-week postmenstrual age. Most failed eyes had favorable anatomical outcomes and over half demonstrated fixation behavior.


Asunto(s)
Bevacizumab/administración & dosificación , Ranibizumab/administración & dosificación , Retina/diagnóstico por imagen , Retinopatía de la Prematuridad/tratamiento farmacológico , Agudeza Visual , Inhibidores de la Angiogénesis/administración & dosificación , Femenino , Angiografía con Fluoresceína/métodos , Estudios de Seguimiento , Fondo de Ojo , Edad Gestacional , Humanos , Recién Nacido , Inyecciones Intravítreas , Masculino , Retinopatía de la Prematuridad/diagnóstico , Estudios Retrospectivos , Factores de Tiempo , Insuficiencia del Tratamiento , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
8.
J Perinatol ; 41(8): 2072-2087, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33758387

RESUMEN

OBJECTIVE: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. STUDY DESIGN: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. RESULTS: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). CONCLUSIONS: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.


Asunto(s)
Parálisis Cerebral , Recien Nacido Extremadamente Prematuro , Desarrollo Infantil , Edad Gestacional , Humanos , Recién Nacido , Inositol/uso terapéutico
9.
Ophthalmology ; 127(9): 1259-1267, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32317177

RESUMEN

PURPOSE: The purpose of this assessment is to evaluate the accuracy of autorefraction compared with cycloplegic retinoscopy in children. METHODS: Literature searches were last conducted in October 2019 in the PubMed and the Cochrane Library databases for studies published in English. The combined searches yielded 118 citations, of which 53 were reviewed in full text. Of these, 31 articles were deemed appropriate for inclusion in this assessment and subsequently assigned a level of evidence rating by the panel methodologists. Four articles were rated level I, 11 were rated level II, and 16 were rated level III articles. The 16 level III articles were excluded from this review. RESULTS: Thirteen of the 15 studies comparing cycloplegic autorefraction with cycloplegic retinoscopy found a mean difference in spherical equivalent or sphere of less than 0.5 diopters (D); most were less than 0.25 D. Even lower mean differences were found when evaluating the cylindrical component of cycloplegic autorefraction versus cycloplegic retinoscopy. Despite low mean variability, there was significant individual measurement variability; the 95% limits of agreement were wide and included clinically relevant differences. Comparisons of noncycloplegic with cycloplegic autorefractions found that noncyloplegic refraction tends to over minus by 1 to 2 D. CONCLUSIONS: Cycloplegic autorefraction is appropriate to use in pediatric population-based studies. Cycloplegic retinoscopy can be valuable in individual clinical cases to confirm the accuracy of cycloplegic autorefraction, particularly when corrected visual acuity is worse than expected or the autorefraction results are not consistent with expected findings.


Asunto(s)
Oftalmología/organización & administración , Refracción Ocular/fisiología , Retinoscopía/normas , Evaluación de la Tecnología Biomédica , Academias e Institutos/organización & administración , Adolescente , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Midriáticos/administración & dosificación , Reproducibilidad de los Resultados , Estados Unidos
10.
JAMA Ophthalmol ; 138(6): 698-701, 2020 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-32324197

RESUMEN

Importance: Intravitreous bevacizumab (0.25 mg to 0.625 mg) is commonly used to treat type 1 retinopathy of prematurity (ROP), but there are concerns about systemic toxicity, particularly the risk of neurodevelopmental delay. A much lower dose may be effective for ROP while reducing systemic risk. Previously, after testing doses of 0.25 mg to 0.031 mg, doses as low as 0.031 mg were found to be effective in small cohorts of infants. Objective: To find the lowest dose of intravitreous bevacizumab effective for severe ROP. Design, Setting, and Participants: Between April 2017 and May 2019, 59 premature infants with type 1 ROP in 1 or both eyes were enrolled in a masked, multicenter, dose de-escalation study. In cohorts of 10 to 14 infants, 1 eye per infant received 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreous bevacizumab. Diluted bevacizumab was prepared by individual research pharmacies and delivered using 300-µL syringes with 5/16-inch, 30-guage fixed needles. Analysis began July 2019. Interventions: Bevacizumab intravitreous injections at 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg. Main Outcomes and Measures: Success was defined as improvement by 4 days postinjection and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks. Results: Fifty-five of 59 enrolled infants had 4-week outcomes completed; the mean (SD) birth weight was 664 (258) g, and the mean (SD) gestational age was 24.8 (1.6) weeks. A successful 4-week outcome was achieved for 13 of 13 eyes (100%) receiving 0.016 mg, 9 of 9 eyes (100%) receiving 0.008 mg, 9 of 10 eyes (90%) receiving 0.004 mg, but only 17 of 23 eyes (74%) receiving 0.002 mg. Conclusions and Relevance: These data suggest that 0.004 mg may be the lowest dose of bevacizumab effective for ROP. Further investigation is warranted to confirm effectiveness of very low-dose intravitreous bevacizumab and its effect on plasma vascular endothelial growth factor levels and peripheral retinal vascularization.


Asunto(s)
Bevacizumab/administración & dosificación , Retinopatía de la Prematuridad/tratamiento farmacológico , Inhibidores de la Angiogénesis/administración & dosificación , Relación Dosis-Respuesta a Droga , Femenino , Estudios de Seguimiento , Humanos , Lactante , Recién Nacido , Inyecciones Intravítreas , Masculino , Receptores de Factores de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Retina/patología , Retinopatía de la Prematuridad/diagnóstico , Resultado del Tratamiento
12.
J AAPOS ; 24(1): 36-37, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31733302

RESUMEN

We report a case of stretched scar syndrome in a 12-year-old girl with consecutive exotropia who had previously been treated with bilateral medial rectus muscle recessions. Stretched scar syndrome was confirmed intraoperatively, and bilateral medial rectus muscle plication was performed, successfully restoring normal alignment. Use of plication rather than resection of rectus muscles (stretched scar) can reduce the risk of a lost or slipped muscle and reduce surgical trauma and bleeding.


Asunto(s)
Cicatriz/cirugía , Exotropía/cirugía , Músculos Oculomotores/cirugía , Procedimientos Quirúrgicos Oftalmológicos/métodos , Visión Binocular/fisiología , Niño , Cicatriz/complicaciones , Exotropía/etiología , Exotropía/fisiopatología , Femenino , Humanos , Síndrome
13.
Ophthalmology ; 127(2): 261-272, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31619356

RESUMEN

PURPOSE: To review the published literature assessing the efficacy of binocular therapy for the treatment of amblyopia compared with standard treatments. METHODS: Literature searches with no date restrictions and limited to the English language were conducted in January 2018 and updated in April 2019 in the PubMed database and the Cochrane Library database with no restrictions. The search yielded 286 citations, and the full text of 50 articles was reviewed. Twenty articles met the inclusion criteria for this assessment and were assigned a level of evidence rating by the panel methodologist. Six studies were rated level I, 1 study was rated level II, and 13 studies were rated level III because of the impact on the development and popularization of this technology. RESULTS: Two of the level I and II studies reviewed described a significant improvement in visual acuity in the binocular group versus standard patching standard treatment (the total number of patients in these 2 studies was 147). However, the 5 studies that failed to show a visual improvement from binocular therapy compared with standard treatments were larger and more rigorously designed (the total number of patients in these 5 studies was 813). Level I and II studies also failed to show a significant improvement over baseline in sensory status, including depth of suppression and stereopsis of those treated with binocular therapy. Several smaller level III case series (total number of patients in these 13 studies was 163) revealed more promising results than the binocular treatments studied in the level I and II studies, especially using treatments that are more engaging and are associated with better compliance. CONCLUSIONS: There is no level I evidence to support the use of binocular treatment as a substitute for current therapies for amblyopia (including patching and optical treatment). Furthermore, 2 large randomized controlled trials showed inferior performance compared with standard patching treatment. On the basis of this review of the published literature, binocular therapy cannot be recommended as a replacement for standard amblyopia therapy. However, more research is needed to determine the potential benefits of proposed binocular treatments in the future.


Asunto(s)
Ambliopía/terapia , Evaluación de la Tecnología Biomédica , Visión Binocular/fisiología , Agudeza Visual/fisiología , Academias e Institutos , Ambliopía/fisiopatología , Bases de Datos Factuales , Humanos , Oftalmología/organización & administración , Estados Unidos
14.
Ophthalmology ; 126(10): 1454-1461, 2019 10.
Artículo en Inglés | MEDLINE | ID: mdl-31230794

RESUMEN

PURPOSE: To compare the visual outcomes and adverse events associated with optical correction using an intraocular lens (IOL), contact lenses, or spectacles after cataract surgery in children 2 years of age or younger. METHODS: Literature searches were conducted in PubMed, the Cochrane Library, and the databases of clinical trials in February 2019, without date or language restrictions. The search resulted in 194 potentially relevant citations, and 34 were selected for full-text review. Fourteen studies were determined to be relevant to the assessment criteria and were selected for inclusion in this assessment. The panel methodologist then assigned a level of evidence rating to these studies. RESULTS: Intraocular lenses were associated with visual outcomes similar to outcomes for contact lenses or spectacles for children who had both bilateral and unilateral cataracts. Intraocular lenses were also associated with an increased risk of visual axis opacities. All treatments were associated with a similar incidence of glaucoma. Although ocular growth was similar for all treatments, infants younger than 6 months who underwent IOL implantation had large myopic shifts that often resulted in high myopia or severe anisometropia later in childhood. Corneal endothelial cell counts were lower in eyes that underwent IOL implantation. The incidence of strabismus was similar with all treatments. CONCLUSIONS: Intraocular lens implantation is not recommended for children 6 months of age or younger because there is a higher incidence of visual axis opacities with this treatment compared with aphakia. The best available evidence suggests that IOL implantation can be done safely with acceptable side effects in children older than 6 months of age. However, the unpredictability of ocular growth means that these children will often have large refractive errors later in childhood that may necessitate an IOL exchange or wearing spectacles or contact lenses with a large refractive correction. In addition, the training and experience of the surgeon as well as ocular and systemic comorbidities should be taken into consideration when deciding whether IOL implantation would be appropriate.


Asunto(s)
Afaquia Poscatarata/cirugía , Extracción de Catarata , Lentes de Contacto , Anteojos , Implantación de Lentes Intraoculares , Afaquia Poscatarata/rehabilitación , Preescolar , Femenino , Humanos , Lactante , Implantación de Lentes Intraoculares/efectos adversos , Lentes Intraoculares , Masculino
15.
Ophthalmol Retina ; 3(5): 436-443, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-31044736

RESUMEN

OBJECTIVE: Medium- and long-term sequelae of intravitreal bevacizumab (IVB) for type 1 retinopathy of prematurity (ROP) are uncertain. Our aim was to describe the fluorescein angiography (FA) findings in patients who received IVB as primary treatment for type 1 ROP and compare them to findings in patients with ROP that spontaneously regressed. DESIGN: Retrospective cohort. PARTICIPANTS: Twenty-eight patients with a history of ROP who underwent fluorescein angiography between December 1, 2013, and July 31, 2018. Patients were divided into 2 groups based on whether they had received IVB or had ROP that spontaneously regressed. METHODS: We reviewed the angiograms in the 2 groups for neovascularization (NV) and other abnormal vascular patterns in both the periphery and the posterior pole. MAIN OUTCOME MEASURES: Fluorescein angiography findings, including NV, peripheral, and macular vascular abnormalities. RESULTS: Forty eyes of 20 infants were included in the IVB group and 16 eyes of 8 infants in the untreated group. Median gestational age at birth was similar in the 2 groups (24.5 and 24.7 weeks, respectively; P = 0.44), as was the median birth weight (648.5 and 560.0 g, respectively; P = 0.26). Median postmenstrual age at the time of FA was 65.1 and 83.9 weeks, respectively (P = 0.0002). Review of angiograms demonstrated NV in 30.0% and 37.5% in the IVB and untreated cohorts, respectively (P = 0.75). Abnormal vascular patterns in the periphery were similar in both groups (100.0%), whereas posterior pole findings of vessels encroaching onto the fovea were more prevalent in the IVB cohort (65.0% vs. 25.0%; P = 0.009). CONCLUSIONS: Fluorescein angiography after bevacizumab for ROP reveals abnormal vascular patterns in all eyes and NV in approximately one-third. Similar abnormal vascular patterns on FA are seen at a similar prevalence after spontaneous regression of ROP. These findings suggest that the abnormal vascular patterns identified by FA in patients with ROP result from the disease process itself rather than as a result of exposure to anti-vascular endothelial growth factor medications.


Asunto(s)
Inhibidores de la Angiogénesis/uso terapéutico , Bevacizumab/uso terapéutico , Retinopatía de la Prematuridad/tratamiento farmacológico , Femenino , Angiografía con Fluoresceína , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Inyecciones Intravítreas , Masculino , Remisión Espontánea , Retinopatía de la Prematuridad/patología , Estudios Retrospectivos
16.
Ophthalmology ; 126(1): 146-155, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30075202

RESUMEN

PURPOSE: To review the published literature assessing the efficacy of ß-blockers for the treatment of periocular hemangioma in infants. METHODS: Literature searches were conducted in May 2018 in PubMed with no date restrictions and limited to studies published in English and in the Cochrane Library database without any restrictions. The combined searches yielded 437 citations. Of these,16 articles were deemed appropriate for inclusion in this assessment and assigned a level of evidence rating by the panel methodologist. RESULTS: None of the 16 studies included in this assessment were rated level I, 3 were rated level II, and 13 were rated level III. The most common treatment regimen was 2 mg/kg daily oral propranolol, but intralesional and topical ß-blockers were also used. Treatment effect was most often measured in terms of reduction in the size of the lesions, which occurred in the majority of patients. ß-Blockers were consistently shown to reduce astigmatism, but this reduction was shown to be statistically significant in only 2 series. The effect of ß-blockers on amblyopia was not adequately documented. ß-Blockers were generally well tolerated and had mild side effects (fatigue, gastrointestinal upset/diarrhea, restlessness/sleep disturbances, minor wheezing, and cold extremities). Complications severe enough to require cessation of treatment occurred in only 2 patients out of a total of 229 who received ß-blockers. CONCLUSIONS: There is limited evidence to support the safety and efficacy of both topical and systemic ß-blockers to promote regression of periocular hemangiomas. Additional research may confirm the best dosage and route of administration to maximize efficacy in reducing induced astigmatism and amblyopia associated with periocular hemangiomas while minimizing side effects.


Asunto(s)
Antagonistas Adrenérgicos beta/uso terapéutico , Neoplasias de los Párpados/tratamiento farmacológico , Hemangioma Capilar/tratamiento farmacológico , Neoplasias Orbitales/tratamiento farmacológico , Propranolol/uso terapéutico , Academias e Institutos/organización & administración , Antagonistas Adrenérgicos beta/efectos adversos , Preescolar , Neoplasias de los Párpados/patología , Hemangioma Capilar/patología , Humanos , Lactante , Recién Nacido , Oftalmología/organización & administración , Neoplasias Orbitales/patología , Propranolol/efectos adversos , Evaluación de la Tecnología Biomédica , Resultado del Tratamiento
17.
Ophthalmology ; 126(4): 623-636, 2019 04.
Artículo en Inglés | MEDLINE | ID: mdl-30476518

RESUMEN

PURPOSE: To review the published evidence to evaluate the ability of orthokeratology (Ortho-K) treatment to reduce myopic progression in children and adolescents compared with the use of spectacles or daytime contact lenses for standard refractive correction. METHODS: Literature searches of the PubMed database, the Cochrane Library, and the databases of clinical trials were last conducted on August 21, 2018, with no date restrictions but limited to articles published in English. These searches yielded 162 citations, of which 13 were deemed clinically relevant for full-text review and inclusion in this assessment. The panel methodologist then assigned a level of evidence rating to the selected studies. RESULTS: The 13 articles selected for inclusion include 3 prospective, randomized clinical trials; 7 nonrandomized, prospective comparative studies; and 3 retrospective case series. One study provided level I evidence, 11 studies provided level II evidence, and 1 study provided level III evidence. Most studies were performed in populations of Asian ethnicity. Change in axial length was the primary outcome for 10 of 13 studies and change in refraction was the primary outcome for 3 of 13 studies. In these studies, Ortho-K typically reduced axial elongation by approximately 50% over a 2-year study period. This corresponds to average axial length change values of approximately 0.3 mm for Ortho-K patients compared with 0.6 mm for control patients, which corresponds to a typical difference in refraction of approximately 0.5 diopters (D). Younger age groups and individuals with larger than average pupil size may have a greater effect with Ortho-K. Rebound can occur after discontinuation or change to alternative refractive treatment. CONCLUSIONS: Orthokeratology may be effective in slowing myopic progression for children and adolescents, with a potentially greater effect when initiated at an early age (6-8 years). Safety remains a concern because of the risk of potentially blinding microbial keratitis from contact lens wear.


Asunto(s)
Miopía/prevención & control , Procedimientos de Ortoqueratología , Academias e Institutos/organización & administración , Niño , Bases de Datos Factuales , Progresión de la Enfermedad , Humanos , Miopía/diagnóstico , Evaluación de la Tecnología Biomédica , Resultado del Tratamiento , Estados Unidos
18.
JAMA ; 320(16): 1649-1658, 2018 10 23.
Artículo en Inglés | MEDLINE | ID: mdl-30357297

RESUMEN

Importance: Previous studies of myo-inositol in preterm infants with respiratory distress found reduced severity of retinopathy of prematurity (ROP) and less frequent ROP, death, and intraventricular hemorrhage. However, no large trials have tested its efficacy or safety. Objective: To test the adverse events and efficacy of myo-inositol to reduce type 1 ROP among infants younger than 28 weeks' gestational age. Design, Setting, and Participants: Randomized clinical trial included 638 infants younger than 28 weeks' gestational age enrolled from 18 neonatal intensive care centers throughout the United States from April 17, 2014, to September 4, 2015; final date of follow-up was February 12, 2016. The planned enrollment of 1760 participants would permit detection of an absolute reduction in death or type 1 ROP of 7% with 90% power. The trial was terminated early due to a statistically significantly higher mortality rate in the myo-inositol group. Interventions: A 40-mg/kg dose of myo-inositol was given every 12 hours (initially intravenously, then enterally when feeding; n = 317) or placebo (n = 321) for up to 10 weeks. Main Outcomes and Measures: Type 1 ROP or death before determination of ROP outcome was designated as unfavorable. The designated favorable outcome was survival without type 1 ROP. Results: Among 638 infants (mean, 26 weeks' gestational age; 50% male), 632 (99%) received the trial drug or placebo and 589 (92%) had a study outcome. Death or type 1 ROP occurred more often in the myo-inositol group vs the placebo group (29% vs 21%, respectively; adjusted risk difference, 7% [95% CI, 0%-13%]; adjusted relative risk, 1.41 [95% CI, 1.08-1.83], P = .01). All-cause death before 55 weeks' postmenstrual age occurred in 18% of the myo-inositol group and in 11% of the placebo group (adjusted risk difference, 6% [95% CI, 0%-11%]; adjusted relative risk, 1.66 [95% CI, 1.14-2.43], P = .007). The most common serious adverse events up to 7 days of receiving the ending dose were necrotizing enterocolitis (6% for myo-inositol vs 4% for placebo), poor perfusion or hypotension (7% vs 4%, respectively), intraventricular hemorrhage (10% vs 9%), systemic infection (16% vs 11%), and respiratory distress (15% vs 13%). Conclusions and Relevance: Among premature infants younger than 28 weeks' gestational age, treatment with myo-inositol for up to 10 weeks did not reduce the risk of type 1 ROP or death vs placebo. These findings do not support the use of myo-inositol among premature infants; however, the early termination of the trial limits definitive conclusions.


Asunto(s)
Recien Nacido Extremadamente Prematuro , Enfermedades del Recién Nacido/mortalidad , Inositol/uso terapéutico , Retinopatía de la Prematuridad/prevención & control , Hemorragia Cerebral Intraventricular/prevención & control , Método Doble Ciego , Femenino , Estudios de Seguimiento , Edad Gestacional , Humanos , Recién Nacido , Inositol/efectos adversos , Cuidado Intensivo Neonatal , Masculino , Retinopatía de la Prematuridad/mortalidad , Insuficiencia del Tratamiento
19.
JAMA Ophthalmol ; 136(12): 1389-1390, 2018 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-30326055
20.
Ophthalmol Retina ; 2(8): 864-871, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-30175314

RESUMEN

PURPOSE: To evaluate (1) the feasibility of non-ophthalmologist healthcare workers (HCWs) to obtain images of sufficient quality for retinopathy of prematurity (ROP) screening using a FDA-approved portable, non-contact, narrow-field fundus camera (i.e., Pictor™), and (2) the accuracy of grading these images to identify infants who developed treatment-warranted (type 1) ROP. DESIGN: Prospective cohort study. SUBJECTS: Infants undergoing routine ROP screening examinations (i.e. birth weight ≤1500 grams and/or gestational age ≤30 weeks or selected infants with a birth weight of 1500-2000g or gestational age >30 weeks and an unstable clinical course). METHODS: We prospectively recruited infants undergoing ROP screening examinations at a community hospital. On the same day an ophthalmologist examined them, a trained HCW imaged their retinas using the non-contact camera. Two masked ROP experts graded these images remotely. We calculated both the percentage of gradable images (i.e. having at least 3 quadrants with sufficient image quality), as well as the accuracy of identifying infants who developed type 1 ROP. MAIN OUTCOME MEASURES: Percentage of gradable images and the sensitivity and specificity of each grader for identifying infants with type 1 ROP by grading for the presence of pre-plus or plus disease. RESULTS: Ninety-nine infants were included. Overall, 92.4% and 94.2% of all infant imaging sessions were considered gradable by graders 1 and 2, respectively. Amongst gradable images, the sensitivity of both graders for identifying type 1 ROP by grading for the presence of pre-plus or plus disease was 100% (95% confidence interval (CI): 95-100%) and the specificity 91% (95% CI: 83-95%) for grader 1 and 93% (95% CI: 86-96%) for grader 2. CONCLUSIONS: It was highly feasible for trained HCWs to obtain digital retinal images of sufficient quality for ROP screening using a non-contact fundus camera. By grading for the presence of pre-plus or plus disease, graders identified infants who developed type 1 ROP with high sensitivity and specificity. The use of portable, non-contact retinal cameras by trained HCWs could increase our workforce in ROP screening and identify infants needing an indirect ophthalmoscopy examination by an ophthalmologist.

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