Digital therapeutic improves visual acuity and encourages high adherence in amblyopic children in open-label pilot study.

BACKGROUND: The effectiveness of amblyopia therapy can be limited by poor adherence. Dichoptic therapies are a new approach, but recent trials have demonstrated difficulty maintaining high adherence over extended periods of at-home treatment. We evaluated the efficacy and adherence of Luminopia One-a dichoptic treatment that applies therapeutic modifications to streaming content chosen by the patient. METHODS: This single-arm, multicenter prospective pilot study enrolled children aged 4-12 with anisometropic, strabismic, or mixed amblyopia at 10 pediatric ophthalmic and optometric practices across the United States. The therapeutic was prescribed for 1 hour/day, 6 days/week for 12 weeks of at-home use. The primary endpoint was best-corrected visual acuity (BCVA) at the 12-week follow-up visit. RESULTS: In total, 90 participants (mean age, 6.7 ± 2.0 years) were enrolled, and 73/90 participants (81%) had prior treatment beyond refractive correction. For those who completed the 12-week visit, mean amblyopic eye BCVA improved from 0.50 logMAR to 0.35 logMAR (1.5 logMAR lines; 95% CI, 1.2-1.8 lines; P < 0.0001). Mean stereoacuity improved by 0.28 log arcsec (95% CI, 0.14-0.42 log arcsec; P < 0.0001). Median adherence was 86% (interquartile range, 70%-97%). CONCLUSIONS: In our study cohort, adherence over the 12-week study period was high, and participants demonstrated clinically and statistically significant improvements in visual acuity and stereoacuity.

Improved adherence and treatment outcomes with an engaging, personalized digital therapeutic in amblyopia.

Given the prevalence of poor adherence to therapy and the biases of self-reporting across healthcare, we hypothesized that an engaging, personalized therapy may improve adherence and treatment outcomes in the home. We tested this hypothesis in the initial indication of amblyopia, a neurodevelopmental disorder for which available treatments are limited by low adherence. We designed a novel digital therapeutic that modifies patient-selected cinematic content in real-time into therapeutic visual input, while objectively monitoring adherence. The therapeutic design integrated a custom-designed headset that delivers precise visual input to each eye, computational algorithms that apply real-time therapeutic modifications to source content, a cloud-based content management system that enables treatment in the home, and a broad library of licensed content. In a proof-of-concept human study on the therapeutic, we found that amblyopic eye vision improved significantly after 12 weeks of treatment, with higher adherence than that of available treatments. These initial results support the utility of personalized therapy in amblyopia and may have broader relevance for improving treatment outcomes in additional indications.

Selection of patients and results of 25 years of topical anesthesia and adjustable suture surgery.

BACKGROUND AND PURPOSE: The author has used adjustable suture techniques either in the operating room with topical anesthesia or at a later time after retrobulbar or general anesthesia for over 25 years. Careful selection of patients is essential to the success of this technique. It is the purpose of this paper to report the selection criteria used and to compare the results of the two methods utilized. PATIENTS AND METHODS: One hundred eighty-three patients were included in this study: 123 were operated upon with topical anesthesia. For comparison, sixty patients were included who had adjustment later in the day or the next day after having retrobulbar or general anesthesia. Both horizontal and vertical strabismus cases were included. RESULTS: Adjustable techniques done in the operating room or at a later time have both shown significant improvement in the strabismus angle following one operation in 86% of the cases. Diplopia was eliminated in 63% of patients with this complaint. (63% and 64.5% in the two groups, respectively). Seventeen of 123 patients having topical anesthesia (13.8%) required a second operation, and 8 of 60 (13.3%) of those having a later adjustment needed further surgery. CONCLUSION: Careful selection of patients undergoing strabismus surgery allows successful topical muscle adjustment in the operating room with results similar to adjustments done following retrobulbar or general anesthesia at a later time.

Factors associated with strabismus in spina bifida myelomeningocele.

PURPOSE: Higher prevalence of strabismus in individuals with spina bifida myelomeningocele (SBM) has previously been attributed to hydrocephalus; however, SBM is associated with many other complications. This study investigates the relation between strabismus and other factors in SBM. METHODS: Children aged 3 to 18 years with SBM (n = 112) received an eye examination including assessment of ocular alignment by cover or Hirschberg test. Gestational age, respiratory distress at birth, birth weight, maternal age at birth, number of shunt revisions, and spinal lesion level were also obtained. The relation between these factors and strabismus was analyzed. RESULTS: Forty-two participants had strabismus. Maternal age (P = .4) and respiratory distress (P = .6) were not significantly related to strabismus. Lower birth weight was suggestive of a relation with strabismus (logistic regression, P = .05) and younger gestational age was related to strabismus (logistic regression, P = .01). Participants who had at least one shunt revision were more likely to have strabismus (Fisher's exact test, P = .038). Spinal lesion level was significantly related to strabismus with increased likelihood of strabismus for spinal lesions closer to the brain (Wald chi-square, 1,100 = 4.29, P = .038). CONCLUSION: These findings indicate that several factors are associated with strabismus in SBM. Some of these factors (lower birth weight and younger gestational age) are associated with strabismus in the general population, whereas the association of strabismus and level of spinal lesion may be unique to SBM and may be related to the more severe brain dysmorphology associated with upper level spinal lesions.

Restrictive horizontal strabismus following blepharoplasty.

PURPOSE: To report a case of horizontal diplopia after a four-lid blepharoplasty. DESIGN: Observational and interventional case report. METHODS: Analysis of the history and management of a 64-year-old man who underwent a four-lid blepharoplasty, after which he developed horizontal diplopia. RESULTS: The patient was found to have a restrictive esotropia. He underwent a recession of the left medial rectus on an adjustable suture, with recurrence of the same pattern of diplopia one month after surgery. CONCLUSIONS: The involvement of the extraocular muscles as a complication of blepharoplasty is uncommon, but when it is present, it may be very difficult to treat.

A prospective study of alternating occlusion before surgical alignment for infantile esotropia: one-year postoperative motor results.

INTRODUCTION: Alternating occlusion before surgical alignment has been suggested by some strabismologists as a possible method to enhance the treatment of infantile esotropia. PURPOSE: This report presents 1-year outcome results of a prospective trial of patients with infantile esotropia who were assigned randomly to alternating occlusion or control groups. METHODS AND MATERIALS: Forty-four patients with infantile esotropia were measured at entry into the study, at the time of surgery, at 6 weeks, and 1 year postoperatively. Alternating occlusion was full time and symmetric for those with no amblyopia but asymmetric for those with amblyopia. The control group that did not receive alternating occlusion had occlusion for amblyopia only. Initial surgeries were performed when the patients were between the ages of 6 and 13 months. RESULTS: Overall, the patients showed an increase of 9.14 prism diopters (PD) during a mean preoperative follow-up of 4.2 months. Seventy-five percent of all patients were aligned by the initial surgery. Ninety-one percent of those patients aligned within 10 PD at 6 weeks also were aligned 1 year postoperatively. The results were similar for the alternate occlusion group and the control group. CONCLUSION: In our sample of patients, alternating occlusion does not detectably alter the increase in angle of deviation between the dates of entry and the date of the initial surgical alignment procedure, nor does it influence the postoperative alignment at 6 weeks or at 1 year.

Reasons for delay of surgical intervention in adult strabismus.

BACKGROUND: It has been our impression that adult patients with strabismus frequently delay surgical intervention. OBJECTIVES: To determine the length of time adult patients waited before undergoing strabismus surgery and to determine the reasons why these delays occurred. DESIGN, SETTING, AND PARTICIPANTS: Prospective survey of consecutive patients who delayed strabismus surgery for more than 1 year. INTERVENTION: Preoperative survey. MAIN OUTCOME MEASURES: The primary outcome measure was time between the onset of strabismus and surgery and the reason why surgery had not been previously sought. RESULTS: The mean age among 128 study participants was 45.7 years (age range, 18-86 years). The mean time between the onset of current strabismus and surgery was 19.9 years (range, 1-72 years). The major reasons for delay in seeking surgical treatment included the following: surgery was never offered by eye care specialist (35 patients [27%]), surgery was offered but declined by the patient (29 patients [23%]), the patient had received prior satisfactory nonsurgical care (17 patients [13%]), the patient had never sought care (14 patients [11%]), the patient had a previous poor surgical experience (8 patients [6%]), and the patient had been told by their eye specialist that nothing could be done or that surgery could make them worse (8 patients [6%]). CONCLUSIONS: Strabismus surgery is often delayed for many years in adult patients who could potentially benefit from it. Almost half of such delays could be avoided by better education of the lay public and the medical community.

A prospective study of alternating occlusion prior to surgical alignment for infantile esotropia: one-year postoperative motor results.

PURPOSE: Alternating occlusion prior to surgical alignment has been suggested by some strabismologists to possibly enhance the treatment of infantile esotropia. This report presents the data for 44 patients prospectively enrolled by random assignment to an alternating occlusion or no occlusion subgroup followed for 1 year postoperatively. METHODS: All patients were measured at entry into the study, at the time of surgery, and at 6 weeks and 1 year postoperatively. Alternating occlusion was full-time and symmetric for those with no amblyopia but asymmetric for those with amblyopia. The subgroup that did not receive alternating occlusion had occlusion for amblyopia only. Initial surgeries were performed between the ages of 6 and 13 months. RESULTS: The patients, as a whole, showed a significant increase of 9.14 prism diopters when followed for a mean of 4.2 months prior to initial surgery (P < .00027). Seventy-five percent of all patients were aligned by the initial surgery. Ninety-one percent of those patients aligned at 6 weeks were also aligned at the 1-year postoperative date. The results were similar for both the control group and the patients treated with alternating occlusion. CONCLUSION: In our sample of patients, alternating occlusion does not detectably alter the increase in angle of deviation between the dates of entry and the date of the initial surgical alignment procedure, nor does it influence the postoperative alignment at 6 weeks or at 1 year.