Outcomes of Bilateral Cataract Surgery in Infants 7 to 24 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry.

PURPOSE: To evaluate outcomes of bilateral cataract surgery in children aged 7 to 24 months and compare rates of adverse events (AEs) with other Toddler Aphakia and Pseudophakia Study (TAPS) registry outcomes. DESIGN: Retrospective clinical study at 10 Infant Aphakia Treatment Study (IATS) sites. Statistical analyses comparing this cohort with previously reported TAPS registry cohorts. PARTICIPANTS: Children enrolled in the TAPS registry between 2004 and 2010. METHODS: Children underwent bilateral cataract surgery with or without intraocular lens (IOL) placement at age 7 to 24 months with 5 years of postsurgical follow-up. MAIN OUTCOME MEASURES: Visual acuity (VA), occurrence of strabismus, AEs, and reoperations. RESULTS: A total of 40 children (76 eyes) who underwent bilateral cataract surgery with primary posterior capsulectomy were identified with a median age at cataract surgery of 11 months (7-23); 68% received a primary IOL. Recurrent visual axis opacification (VAO) occurred in 7.5% and was associated only with the use of an IOL (odds ratio, 6.10; P = 0.005). Glaucoma suspect (GS) was diagnosed in 2.5%, but no child developed glaucoma. In this bilateral cohort, AEs (8/40, 20%), including glaucoma or GS and VAO, and reoperations occurred in a similar proportion to that of the published unilateral TAPS cohort. When analyzed with children aged 1 to 7 months at bilateral surgery, the incidence of AEs and glaucoma or GS correlated strongly with age at surgery (P = 0.011/0.004) and glaucoma correlated with microcornea (P = 0.040) but not with IOL insertion (P = 0.15). CONCLUSIONS: Follow-up to age 5 years after bilateral cataract surgery in children aged 7 to 24 months reveals a low rate of VAO and very rare glaucoma or GS diagnosis compared with infants with cataracts operated at < 7 months of age despite primary IOL implantation in most children in the group aged 7 to 24 months. The use of an IOL increases the risk of VAO irrespective of age at surgery.

The Myopic Shift in Aphakic Eyes in the Infant Aphakia Treatment Study After 10 Years of Follow-up.

OBJECTIVES: To report the myopic shift in the aphakic eyes of a cohort of children who underwent unilateral cataract surgery during infancy and were then followed longitudinally for 10.5 years. METHODS: One-half of the children enrolled in the Infant Aphakia Treatment Study (IATS) were randomized to aphakia and contact lens correction after unilateral cataract surgery. They then underwent ocular examinations using standardized protocols at prescribed time intervals until age 10.5 years. RESULTS: Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months. The median refractive error (RE) in the 57 eyes randomized to aphakia immediately after cataract surgery was 19.01 D (IQR: 16.98-20.49) compared to 10.38 D (IQR: 7.50-14.00) for the 30 eyes that remained aphakic at age 10.5 years. The mean change in RE in aphakic eyes was -2.11 D/year up to age 1.5 years, -0.68 D/year from 1.5 to 5.0 years, and -0.35 D/year from age 5 to 10.5 years. At age 10.5 years, 18 patients continued to wear a contact lens correction (silicone elastomer, n=6; gas permeable, n=6; hydrogel, n=5; and silicone hydrogel, n=1) (median RE, 12.50 D), 9 wore only spectacles (median RE, 4.00 D), and 4 wore no correction (median RE, 11.25 D) to correct their aphakic eye. CONCLUSIONS: The RE in aphakic eyes decreased by 44% from infancy to age 10.5 years. About two-thirds of children who remained aphakic at age 10.5 years continued to wear a contact lens.

Outcomes of Bilateral Cataracts Removed in Infants 1 to 7 Months of Age Using the Toddler Aphakia and Pseudophakia Treatment Study Registry.

PURPOSE: To evaluate outcomes of bilateral cataract surgery in infants 1 to 7 months of age performed by Infant Aphakia Treatment Study (IATS) investigators during IATS recruitment and to compare them with IATS unilateral outcomes. DESIGN: Retrospective case series review at 10 IATS sites. PARTICIPANTS: The Toddler Aphakia and Pseudophakia Study (TAPS) is a registry of children treated by surgeons who participated in the IATS. METHODS: Children underwent bilateral cataract surgery with or without intraocular lens (IOL) placement during IATS enrollment years 2004 through 2010. MAIN OUTCOME MEASURES: Visual acuity (VA), strabismus, adverse events (AEs), and reoperations. RESULTS: One hundred seventy-eight eyes (96 children) were identified with a median age of 2.5 months (range, 1-7 months) at the time of cataract surgery. Forty-two eyes (24%) received primary IOL implantation. Median VA of the better-seeing eye at final study visit closest to 5 years of age with optotype VA testing was 0.35 logarithm of the minimum angle of resolution (logMAR; optotype equivalent, 20/45; range, 0.00-1.18 logMAR) in both aphakic and pseudophakic children. Corrected VA was excellent (<20/40) in 29% of better-seeing eyes, 15% of worse-seeing eyes. One percent showed poor acuity (≥20/200) in the better-seeing eye, 12% in the worse-seeing eye. Younger age at surgery and smaller (<9.5 mm) corneal diameter at surgery conferred an increased risk for glaucoma or glaucoma suspect designation (younger age: odds ratio [OR], 1.44; P = 0.037; and smaller cornea: OR, 3.95; P = 0.045). Adverse events also were associated with these 2 variables on multivariate analysis (younger age: OR, 1.36; P = 0.023; and smaller cornea: OR, 4.78; P = 0.057). Visual axis opacification was more common in pseudophakic (32%) than aphakic (8%) eyes (P = 0.009). Unplanned intraocular reoperation occurred in 28% of first enrolled eyes (including glaucoma surgery in 10%). CONCLUSIONS: Visual acuity after bilateral cataract surgery in infants younger than 7 months is good, despite frequent systemic and ocular comorbidities. Although aphakia management did not affect VA outcome or AE incidence, IOL placement increased the risk of visual axis opacification. Adverse events and glaucoma correlated with a younger age at surgery and glaucoma correlated with the presence of microcornea.

Outcomes of Unilateral Cataracts in Infants and Toddlers 7 to 24 Months of Age: Toddler Aphakia and Pseudophakia Study (TAPS).

PURPOSE: To evaluate outcomes of unilateral cataract surgery in children 7 to 24 months of age. DESIGN: Retrospective case series at 10 Infant Aphakia Treatment Study (IATS) sites. PARTICIPANTS: The Toddler Aphakia and Pseudophakia Study is a registry of children treated by surgeons who participated in the IATS. METHODS: Children underwent unilateral cataract surgery with or without intraocular lens (IOL) placement during the IATS enrollment years of 2004 and 2010. MAIN OUTCOME MEASURES: Intraoperative complications, adverse events (AEs), visual acuity, and strabismus. RESULTS: Fifty-six children were included with a mean postoperative follow-up of 47.6 months. Median age at cataract surgery was 13.9 months (range, 7.2-22.9). Ninety-two percent received a primary IOL. Intraoperative complications occurred in 4 patients (7%). At 5 years of age, visual acuity of treated eyes was very good (≥20/40) in 11% and poor (≤20/200) in 44%. Adverse events were identified in 24%, with a 4% incidence of glaucoma suspect. An additional unplanned intraocular surgery occurred in 14% of children. Neither AEs nor intraocular reoperations were more common for children with surgery at 7 to 12 months of age than for those who underwent surgery at 13 to 24 months of age (AE rate, 21% vs. 25% [P = 0.60]; reoperation rate, 13% vs. 16% [P = 1.00]). CONCLUSIONS: Although most children underwent IOL implantation concurrent with unilateral cataract removal, the incidence of complications, reoperations, and glaucoma was low when surgery was performed between 7 and 24 months of age and compared favorably with same-site IATS data for infants undergoing surgery before 7 months of age. Our study showed that IOL implantation is relatively safe in children older than 6 months and younger than 2 years.

Globe Axial Length Growth at Age 5 Years in the Infant Aphakia Treatment Study.

PURPOSE: To report the longitudinal change in axial length (AL) from the time of unilateral cataract surgery at age 1 to 7 months to age 5 years, and to compare AL growth of operated eyes with that of fellow unoperated eyes. DESIGN: Comparative case series. PARTICIPANTS: Infants enrolled in the Infant Aphakia Treatment Study (IATS). METHODS: The AL at baseline and age 5 years and change in AL were analyzed relative to treated versus fellow eye, visual outcome, and treatment modality (contact lens [CL] vs. intraocular lens [IOL]). Eyes with glaucoma or glaucoma suspect were excluded from primary analysis but reported separately. MAIN OUTCOME MEASURES: The AL growth from preoperative to age 5 years. RESULTS: Seventy patients were eligible; however, AL data for both eyes were available for 64 patients at baseline and 69 patients at age 5 years. The AL was significantly different between treated and fellow eyes preoperatively (18.1 vs. 18.7 mm, P < 0.0001) and at the final follow-up (21.4 vs. 22.1 mm, P = 0.0004). The difference in AL growth between treated and fellow eyes was not significant (3.3 vs. 3.5 mm, P = 0.31). The change in AL in eyes was similar with both treatments (CL 3.2 mm and IOL 3.4 mm, P = 0.53) and did not correlate with visual outcomes (P = 0.85). Eyes receiving additional surgery to clear the visual axis opacification grew significantly more compared with eyes not receiving surgery to clear the visual axis (3.8 vs. 2.7 mm, P = 0.013). Patients with glaucoma showed significantly more eye growth (5.7 mm) than those without glaucoma (3.3 mm) and glaucoma suspects (4.3 mm). CONCLUSIONS: Eyes treated for monocular cataract in infancy have axial growth similar to that of fellow eyes, despite having a shorter AL at the time of surgery. The change in AL in eyes was similar with both treatments (CL and IOL), did not correlate with visual outcomes, and was higher in eyes receiving additional surgery to clear the visual axis or eyes diagnosed with glaucoma.

Myopic Shift 5 Years after Intraocular Lens Implantation in the Infant Aphakia Treatment Study.

PURPOSE: To report the myopic shift at 5 years of age after cataract surgery with intraocular lens (IOL) implantation for infants enrolled in the Infant Aphakia Treatment Study (IATS). METHODS: Refractions were performed at 1 month and every 3 months postoperatively until age 4 years and then at ages 4.25, 4.5, and 5 years. The change in refraction over time was estimated by linear mixed model analysis. RESULTS: Intraocular lens implantation was completed in 56 eyes; 43 were analyzed (median age, 2.4 months; range, 1.0-6.8 months). Exclusions included 11 patients with glaucoma, 1 patient with Stickler syndrome, and 1 patient with an IOL exchange at 8 months postoperatively. The mean rate of change in a myopic direction from 1 month after cataract surgery to age 1.5 years was 0.35 diopters (D)/month (95% confidence interval [CI], 0.29-0.40 D/month); after age 1.5 years, the mean rate of change in a myopic direction was 0.97 D/year (95% CI, 0.66-1.28 D/year). The mean refractive change was 8.97 D (95% CI, 7.25-10.68 D) at age 5 years for children 1 month of age at surgery and 7.22 D (95% CI, 5.54-8.91 D) for children 6 months of age at surgery. The mean refractive error at age 5 years was -2.53 D (95% CI, -4.05 to -1.02). CONCLUSIONS: After IOL implantation during infancy, the rate of myopic shift occurs most rapidly during the first 1.5 years of life. Myopic shift varies substantially among patients. If the goal is emmetropia at age 5 years, then the immediate postoperative hypermetropic targets should be +10.5 D at 4 to 6 weeks and +8.50 D from 7 weeks to 6 months. However, even using these targets, it is likely that many children will require additional refractive correction given the high variability of refractive outcomes.

Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery in the infant aphakia treatment study at age 5 years.

PURPOSE: To analyze differences in the cost of treatment for infants randomized to primary intraocular lens (IOL) implantation versus optical correction with a contact lens (CL) after unilateral cataract surgery in the Infant Aphakia Treatment Study (IATS). DESIGN: Retrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid reimbursement data as well as actual costs of supplies used during the study, adjusted for inflation. PARTICIPANTS: The IATS is a multicenter (n = 12), randomized clinical trial comparing the optical treatment of aphakia with either primary IOL implantation (n = 57) or CL correction (n = 57) in 114 infants with unilateral congenital cataract. INTERVENTION: One hundred fourteen infants underwent unilateral cataract surgery and were either corrected optically by primary IOL implantation at the time of surgery or were corrected with a CL after surgery. MAIN OUTCOME MEASURES: The mean cost of cataract surgery and all additional surgeries, examinations, and supplies used up to 5 years of age. RESULTS: The 5-year treatment cost of an infant with a unilateral congenital cataract corrected optically with an IOL was $27 090 versus $25 331 for a patient treated with a CL after initial cataract surgery. The total cost of supplies was $3204 in the IOL group versus $7728 in the CL group. CONCLUSIONS: Unilateral cataract surgery in infancy coupled with primary IOL implantation is approximately 7% more expensive than aphakia and CL correction. Patient costs are more than double with CL versus IOL treatment.

Predictors of early secondary IOL implantation after pediatric cataract surgery.

BACKGROUND: Pediatric aphakia may be treated conservatively with aphakic contacts or spectacles. Many families and surgeons opt for a secondary intraocular lens (IOL) when the child is older. In certain situations, pediatric aphakic patients must undergo implantation earlier than planned. The purpose of this study was to investigate how often and why early implantation occurs. METHODS: We retrospectively reviewed the medical records of consecutive patients who were left aphakic after cataract surgery in infancy and were seen at our institute at ≥4 years of age. Early implantation was defined as occurring at <4 years of age. RESULTS: A total of 175 patients fit inclusion criteria. We found that 22 of 90 patients (24%) with unilateral cataracts had undergone early secondary IOL implantation before 4 years of age compared to 10 of 85 patients (12%) with bilateral cataracts, a statistically significant difference in the relative risk of early implantation (OR 2.43 [95% CI 1.07-5.49]). Of our patients undergoing early implantation, 15 of 31 (44%) had Medicaid as the primary insurance provider, which is representative of the practice overall. In patients requiring early implantation, failure with contact lens accounted for 26 of 32 cases (81%), with 7 of 26 (27%) of these failures attributed to nonmedical reasons. CONCLUSIONS: Of the factors we analyzed, only the presence of unilateral aphakia was associated with increased risk of early IOL implantation in our study cohort.

External Validation of a Model to Predict Postoperative Globe Axial Length in Children After Bilateral Cataract Surgery.

PURPOSE: To perform the external validation of a model to predict postoperative axial length (AL) in children over 2 years of age who were undergoing bilateral cataract surgery with primary intraocular lens (IOL) implantation. DESIGN: Validation study using a retrospective case series. METHODS: Using a population different from the one that created the model, but with the same characteristics regarding age, bilateral cataract, primary IOL implantation, and follow-up assessment, AL was estimated. The AL values estimated by the model were compared with the AL measured in the follow-ups. RESULTS: In all, 55 eyes of 30 children were selected for this study; in 5 children with bilateral cataracts, only 1 eye was included. The median age at the time of surgery was 5.01 years. Follow-up AL measurements were obtained for 179 visits. The median age at the final follow-up visit was 10.15 years. The median AL measured and estimated by the model in all visits were 22.37 mm and 22.16 mm, respectively (Pearson coefficient: 0.9534; Lin correlation: 0.9258). In the Bland-Altman analysis, the 95% limit of agreement between the 2 methods (measured and estimated AL) was 0.71 to -1.19. In 3 eyes (1.68%) with AL shorter than 21.2 mm, the difference was >0.71, and in 9 eyes with AL longer than 22.5 (5.03%), it was less than -1.19. The median AL measured and estimated at the final visit were 22.69 mm and 22.43 mm, respectively. CONCLUSION: Our previously developed prediction model for globe AL growth demonstrated good external validity by accurately predicting measured AL changes with growth in the validation cohort.

Comparison of HOTV optotypes and Lea Symbols: a systematic review and meta-analysis.

PURPOSE: To report the findings of our systematic review and meta-analysis comparing the completion time and testing time of visual acuity testing using Lea Symbols or HOTV optotypes. METHODS: A systematic search of PubMed, SCOPUS, and CINAHL was conducted according to the PRISMA guidelines. RESULTS: The completion rate for HOTV optotypes and Lea Symbols visual acuity testing was reported for 7,948 patients (average age, 3.59 years; age range, 2-17; 49.96% females). The 3-year-olds' completion rate of HOTV was 74.09% (47.93%-93.29%), compared with a Lea Symbols completion rate of 77.80% (53.93%-94.57%). The 4-year-olds' completion rate was 88.20% (63.48%-99.73%) for HOTV and 90.118% (67.42%-99.90%) for Lea Symbols. In 3-year-olds, the mean testing time was 118.33 ± 6.54 seconds for HOTV and 120.33 ± 6.53 seconds for Lea Symbols (P < 0.0001). The difference in testing times in the 4-year-old age group was also statistically significant (86.98 ± 6.12 seconds for HOTV and 94.32 ± 6.57 seconds for Lea symbols) (P < 0.0001). CONCLUSIONS: There was a statistically significant difference in the testing times between the HOTV optotypes and Lea Symbols in both the 3- and 4-year-old age groups; however, the difference of 2-7 seconds on average is unlikely to be clinically significant. Testing speed and completion rate improve with age for both tests.

Effectiveness of the Spot tm Vision Screener With Variations in Ocular Pigments.

PURPOSE: To evaluate Spot in detecting American Association for Pediatric Ophthalmology and Strabismus (AAPOS) Amblyopia risk factors (ARF) and for ARF myopia and hyperopia with variations in ocular pigments. DESIGN: Diagnostic screening test evaluation. METHODS: Study population: Children presented for a complete eye examination in pediatric clinic. The study population included 1040 participants, of whom 273 had darkly pigmented eyes, 303 were medium pigmented, and 464 were light pigmented. INTERVENTION: Children were screened with the Spot vision screener before the complete eye examination. A pediatric ophthalmologist then completed an eye examination, including cycloplegic refraction. The pediatric ophthalmologist was blinded to the result of the Spot vision screener. MAIN OUTCOME: The association between Spot screening recommendation and meeting one or more ARF/ARF + Amblyopia criterion, Spot measured spherical equivalent, and ARF myopia and hyperopia detection. RESULTS: The area under the receiver operative characteristic curve (AUC) for myopia was excellent for all. The AUC for hyperopia was good (darker-pigmented: 0.92, medium-pigmented: 0.81, and lighter-pigmented: 0.86 eyes). The Spot was most sensitive for ARF myopia (lighter-pigmented: 0.78, medium-pigmented: 0.52, darker-pigmented: 0.49). The reverse was found for hyperopia; however, sensitivity was relatively poor. The Spot was found most sensitive for hyperopia in the darker-pigment group (0.46), 0.27 for medium-pigment, and 0.23 for the lighter-pigment cohort. CONCLUSIONS: While the Spot was confirmed as a sensitive screening test with good specificity in our large cohort, the sensitivity of the Spot in detecting AAPOS guidelines for myopia and hyperopia differed with variations in skin pigment. Our results support the consideration of ethnic and racial diversity in future advances in photorefractor technology.

Selection of an initial contact lens power for infantile cataract surgery without primary intraocular lens implantation.

PURPOSE: To provide guidelines for the selection of an initial contact lens (CL) power based on the preoperative characteristics of the patient in eyes undergoing infantile cataract surgery without primary intraocular lens (IOL) implantation. DESIGN: Cohort study. PARTICIPANTS: Eyes were included if cataract surgery was performed without primary IOL implantation before 1 year of age, a SilSoft CL (Bausch & Lomb, Rochester, NY) was placed immediately after surgery, and postoperative refraction data were available within 1 month after surgery. METHODS: The target CL power was calculated by using the postoperative refraction at the corneal plane for each eye. A regression formula was derived using the targeted CL power and the axial length (AL). The CL power also was estimated using various formulas. An A-constant was derived to estimate CL power using IOL power calculation formula. MAIN OUTCOME MEASURES: Contact lens power. RESULTS: Fifty eyes of 50 patients were analyzed. Age at the time of cataract surgery was 2.4 ± 1.7 months. Refraction at the corneal plane was 29.6 ± 4.4 diopters (D). Regression analysis revealed that CL power=84.4 - 3.2 × AL (R(2) = 0.82; P<0.001). Contact lens power can be estimated using an A-constant of 112.176 in the IOL power calculation formula. If a CL power of 32 D had been used, 22 (44%) of 50 eyes would have needed a replacement of CL. CONCLUSIONS: We devised guidelines on selecting the initial CL power based on preoperative AL. The IOL power calculator also can help to estimate CL power. Refraction at the conclusion of surgery in infants may be difficult, and preoperative biometry can be used to estimate CL power. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Preoperative central corneal thickness in eyes with pediatric cataract versus normal fellow eyes.

PURPOSE: To compare the preoperative central corneal thickness (CCT) in eyes with unilateral cataract with their normal fellow eyes in the pediatric population. METHODS: A retrospective chart review was conducted using the STORM Kids cataract database. Eyes with traumatic cataract, previous surgery or therapeutic manipulation, or age >18 years were excluded. Only eyes with a normal fellow eye were included. The intraocular pressure, age at time of surgery, race, sex, and type of cataract were also extracted from the record. RESULTS: A total of 70 eyes with unilateral cataract and 70 fellow normal eyes met inclusion criteria. The mean age at the time of surgery was 3.35 years (range, 0.08-15.05). The mean preoperative CCT in the operated eyes was 577 ± 58 µm (range, 464-898 µm). The mean preoperative CCT in fellow eyes was 570 ± 35 µm (range, 485-643 µm). There was no statistically significant difference between the preoperative CCT in cataract eyes versus unaffected fellow eyes (P = 0.183). When stratified by age, the difference in the CCT between cataract and fellow eyes was greatest in the <1 year age group, but was not statistically significant (P = 0.236). The mean preoperative corneal diameter of operative eyes was 11.0 mm (range, 5.5-12.5 mm [n = 68]). The mean preoperative IOP was 15.1 mm Hg (n = 66). CONCLUSIONS: In our study cohort, there was no significant difference in mean preoperative CCT between unilateral pediatric cataract eyes and unaffected fellow eyes.

Intraoperative discovery of lens dislocation in a child with Knobloch syndrome.

We present the case of a 14-year-old boy with a known diagnosis of Knobloch syndrome (KS) referred for bilateral cataract evaluation and possible cataract surgery. At time of initial presentation, no lens subluxation was appreciated, and no phacodonesis was detected on slit lamp biomicroscopy. However, 7-weeks later, on the day of surgery, his right eye was found to have a complete lens dislocation into the vitreous cavity, with no zonule attachment. The left eye did not have subluxated lens; however, intraoperatively, after irrigation into the eye, near complete zonular dialysis was observed. This case highlights the importance of regular follow-up of children with KS.

Congenital Fibrosis of Extraocular Muscles: A Systematic Review and Meta-Analysis.

PURPOSE: To quantify typical disease characteristics for patients with congenital fibrosis of the extraocular muscles (CFEOM) including pre-and post-surgical ocular alignment and head positioning as well as average improvement with surgical intervention. PATIENTS AND METHODS: This investigation is a systematic review and meta-analysis. All studies detailing surgical intervention in cohorts of individuals with CFEOM were included. Ocular alignment and head positioning before and after surgery was recorded. Meta-analyses were performed to quantify these findings along with other patient characteristics across all included studies. RESULTS: The estimated average improvement in vertical alignment for patients with unilateral and bilateral CFEOM was 34.8 pd (prism diopters) and 21.27 pd, respectively. For horizontal alignment, patients with unilateral and bilateral CFEOM improved an average of 25.39 pd and 10.99 pd after surgery, respectively. There was no significant difference between the two most common surgeries used to address hypotropia and blepharoptosis in this patient population. The estimated proportion of patients with post-surgical head alignment within 5-9° was 60.64% and was 28.25% for patients with<5° of alignment. CONCLUSION: This study was able to illuminate many characteristic features of patients with CFEOM. Surgical intervention for the ocular alignment and head positioning of these patients demonstrates promising utility.

Effectiveness of the Spot Vision Screener using updated 2021 AAPOS guidelines.

PURPOSE: To evaluate the Spot Vision Screener according to updated 2021 AAPOS Vision Screening Committee guidelines for instrument-based pediatric vision screen validation. METHODS: As part of an IRB-approved ongoing prospective study, children were screened with the Spot prior to a complete examination. RESULTS: Spot screening was successful in 1,036 of 1,090 children (95%). Forty-eight percent of participants were referred for further screening using the Spot manufacturer guidelines, and 40% of all children were found to have a 2021 amblyopia risk factor or visually significant refractive error by gold standard examination. The Spot recommendation compared reasonably well to the 2021 criteria, with an overall sensitivity of 0.88 and a specificity of 0.78. Applying updated guidelines to the Spot for hyperopia, anisometropia, and astigmatism yielded moderate-to-poor sensitivity (0.27-0.77) but excellent specificity (>0.9). The area under the curve of the receiver operating characteristic analysis demonstrates overall good prediction performance for the Spot for each diagnosis-myopia, hyperopia, astigmatism, anisometropia (range, 0.87-0.97). Results of our study suggest increasing the instrument referral criterion for astigmatism from 1.5 D (manufacturer thresholds of the screener used in this study) to 2 D in older children. Decreasing the anisometropia cut-off from 1 D to 0.75 D would improve sensitivity from 0.59 to >0.8. CONCLUSIONS: In our study population, the overall predictive ability of the Spot is good, with a sensitivity of 0.88 and a specificity of 0.78. We recommend specific device refractive referral criteria to maximize screening effectiveness using the updated AAPOS guidelines.