Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial.

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.

Effects of Myo-inositol on Type 1 Retinopathy of Prematurity Among Preterm Infants <28 Weeks' Gestational Age: A Randomized Clinical Trial.

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.

Goniotomy versus circumferential trabeculotomy with an illuminated microcatheter in congenital glaucoma.

PURPOSE: To compare circumferential trabeculotomy performed with an illuminated microcatheter with standard goniotomy for the treatment of congenital glaucoma. METHODS: The short-term results of catheter-assisted trabeculotomy with an illuminated microcatheter were retrospectively compared with those of goniotomy in patients treated for congenital glaucoma. Success with either approach was defined as an intraocular pressure (IOP) <21 mm Hg with at least a 30% reduction from preoperative pressure levels at 12-month follow-up. Complete success was defined when the target IOP levels were reached without the use of antiglaucoma medication, and qualified success was defined when antiglaucoma drops were required to meet this level of IOP. RESULTS: A total of 24 eyes of 20 patients were included. Microcatheter-assisted circumferential trabeculotomy demonstrated a 91.6% qualified and 83.3% unqualified success rate with 12-month follow-up that exceeded the 53.8% qualified and 46.2% unqualified success rate of conventional goniotomy. CONCLUSIONS: In congenital glaucoma, during the first year after surgery, trabeculotomy performed with an illuminated microcatheter appears to be more effective than ab interno goniotomy. No complications were seen in either group; however, the follow-up was relatively short.

Circumferential trabeculotomy with an illuminated microcatheter in congenital glaucomas.

PURPOSE: To determine the safety and efficacy of circumferential trabeculotomy for congenital glaucomas using an illuminated microcatheter. METHODS: This was a retrospective chart study involving 11 eyes from 7 patients with primary or secondary congenital or juvenile glaucoma who underwent circumferential trabeculotomy performed with an illuminated microcatheter over a 2-year period. Data from eyes with 6 or more months of follow-up intraocular pressure (IOP) data were included in the analysis. Mean IOP was determined along with a survival analysis. Unqualified success was defined as an IOP<21 mm Hg and at least a 30% reduction in IOP without the use of IOP-lowering agents and a qualified success when medications were needed to reach this goal. RESULTS: Mean IOP (mm Hg) was reduced from 33.8±6.3 preoperatively to 18.3±3.5 at the final postoperative visit (P-value<0.001). Length of follow-up was 8 to 12 months (mean of 11 mo). A qualified success was seen in 90.1% of eyes and an unqualified success in 81.8%. If eyes with previous angle surgery were excluded, the unqualified success was 87.5% and the qualified success was 100%. Transient hyphema was seen in all cases. No long-term surgical complications were seen. CONCLUSIONS: Circumferential trabeculotomy performed with an illuminated microcatheter provided significant IOP lowering in all patients with unqualified success in the majority of eyes and no significant complications. Further study with even longer follow-up is needed.

Masked trial of topical anesthesia for retinopathy of prematurity eye examinations.

PURPOSE: To observe the effect of a topical anesthetic on pain and corneal clarity in premature infants undergoing eye examinations for retinopathy of prematurity (ROP). METHODS: ROP examinations were performed on premature infants who were randomized to receive either proparacaine 0.5% or an artificial tear solution in the right eye. All infants received an artificial tear solution in the left eye. Assessment of discomfort was performed by use of the Premature Infant Pain Profile (PIPP) during examination of the right eye, with a painful event defined as a PIPP score≥11. The left eye was then examined and a comparison of corneal clarity was made between the 2 eyes. RESULTS: A total of 39 examinations were performed on 34 infants: artificial tear solution was administered 17 times and topical proparacaine anesthetic 22 times. The mean PIPP score for those receiving artificial tears was 10.4 compared with 8.8 for the anesthetic group (p=0.17). Of the examinations without anesthetic, 65% were painful, compared with 27% with anesthetic (p=0.04). No effect on corneal clarity was observed in any examination. CONCLUSIONS: The use of a topical anesthetic appears to marginally decrease pain and has no adverse effect on subjectively assessed corneal clarity during examination of premature infants for ROP.

Congenital osteoma cutis of the lateral canthus.

Osteoma cutis is a rare condition involving the formation of bone in skin or subcutaneous tissue. This may be a primary event or, more often, secondary to an inflammatory, traumatic, or neoplastic process. There is little evidence in the literature of this condition involving the eye or ocular adnexal structures. The authors report two remarkably similar cases involving children with congenital isolated osteoma cutis involving the left lateral canthus.

Graded unilateral supramaximal medial rectus recession for moderate angle esotropia.

BACKGROUND AND PURPOSE: Recession of a single medial rectus muscle may be appropriate for certain cases of esotropia. However, the procedure has not been widely accepted nor widely studied, and most reports have dealt with conventional recessions (3.5-6 mm) for small angle esotropia. We reviewed our patients who underwent unilateral supramaximal (6-8 mm) medial rectus recession for both small and medium angle esotropia. DESIGN: Observational case series. METHODS: The records of 56 consecutive patients, undergoing single eye muscle surgery for esotropia, ranging in age from 1 to 11 years were selected and analyzed. All patients had a constant esotropia, despite full cycloplegic refractive correction, measuring 15-40 prism diopters (mean=25.82) at distance and 18-45 prism diopters (mean=30.71) at near. Each patient underwent a graded unilateral medial rectus recession of 6-8 mm. RESULTS: 48/56 (86%) patients achieved "successful" binocular motor alignment (defined as 0-8 prism diopters residual esotropia at the most recent postoperative visit with a minimum of 5 months and an average of 32 months postoperative followup). The average unilateral medial rectus recession performed was 7.4 mm. Five patients (9%) were overcorrected, (defined as any amount of consecutive exodeviation). CONCLUSION: Unilateral supramaximal medial rectus recession appears to be a safe and effective treatment for medium angle non-accommodative esotropia, and has advantages for both patient and surgeon.

Elimination of paradoxical diplopia following treatment with botulinum toxin and prism.

BACKGROUND: Paradoxical diplopia occurs when binocular visual cerebral cortex projection of diplopic images (the "subjective angle") is not commensurate and identical with angle or direction of strabismus (the "objective angle"). Its presence infers anomalous retinal correspondence and is manifest as heteronymous or crossed diplopia in esotropia and homonymous or uncrossed diplopia in exotropia. When treated, the prognosis for achieving fusion is poor, while the risk for intractable diplopia is reputedly high. We report a patient with paradoxical diplopia that resolved (and some binocular fusion developed) following botulinum toxin injections and prism therapy. RESEARCH DESIGN: Case report. CASE REPORT: A 25 year old man was evaluated for an exotropia. At age 4 years, he had acquired an esotropia due to a traumatic lateral rectus palsy. The esotropia resolved over 3 years. At age 14 years, he developed a consecutive exotropia. The exotropia was eventually treated surgically. There remained a residual exotropia following surgery, and he experienced paradoxical diplopia and projected it homonymously on all sensory tests as if he was esotropic. Treatment with botulinum toxin injections to both lateral rectus muscles along with a small prismatic correction in spectacles eliminated the exotropia and paradoxical diplopia, permitting some binocular fusion. CONCLUSION: Botulinum toxin injection and prism therapy can be effective in eradicating paradoxical diplopia.

Combined superior oblique tuck and adjustable suture recession of the ipsilateral superior rectus for long-standing superior oblique palsy.

PURPOSE: Unilateral long-standing superior oblique palsy may lead to superior rectus overaction/contracture requiring surgery of multiple extraocular muscles to correct the hypertropia. We review our technique of tucking the superior oblique combined with immediate postoperative adjustable suture recession of the ipsilateral superior rectus. METHODS: Twelve patients during the course of 2.5 years with longstanding vertical diplopia unrelated to closed head trauma or systemic disease who underwent our surgical technique were identified. The hypertropia in all patients was largest across the lower field (Knapp class 5) or nasal and lower fields (Knapp class 4). Outcome measures were primary-position hypertropia and vertical diplopia. RESULTS: The mean preoperative hypertropia in primary gaze measured 17.8 PD (range, 4 to 30). The mean 2-week postoperative vertical deviation was 1.3 PD (range, 4 PD hypotropic to 6 PD hypertrophic). The mean 6-week postoperative vertical deviation was 1.9 PD (range, 2 PD hypotropic to 12 PD hypertrophic). Diplopia in primary and down gaze, which was universally present before surgery, resolved in 11 of the 12 patients (92%). CONCLUSIONS: This combination of procedures appears to be a highly successful choice for treatment of unilateral long-standing superior oblique palsy. Advantages for both patient and surgeon include adequate exposure through a single conjunctival incision, elimination of risks to the contralateral eye, and immediate intraoperative suture adjustment of the ipsilateral superior rectus.

The immediate postoperative adjustment of sutures in strabismus surgery with comaintenance of anesthesia using propofol and midazolam.

PURPOSE: Adjustable suture techniques are used to reduce the reoperation rate in strabismus surgery, but traditionally require that final adjustments be made between 1 to 24 hours after surgery. The purpose of this study was to evaluate a new anesthetic technique that would allow immediate postoperative adjustment of sutures in strabismus surgery, thereby improving patient convenience and comfort. METHODS: This was a prospective study of strabismus patients who were judged to be appropriate candidates for adjustable sutures. Comaintenance of anesthesia was accomplished using a stepped-down infusion of propofol with midazolam. Final suture adjustments were performed in the operating room immediately upon completion of strabismus surgery. Patient satisfaction was assessed 24 hours later. Patients were followed for 6 weeks postoperatively. RESULTS: A total of 16 patients were studied, with 8 patients having horizontal muscle surgery, 7 patients with vertical muscle surgery, and 1 patient undergoing both horizontal and vertical muscle surgery. The change in deviation after 6 weeks of follow-up was 8 PD or less horizontally in all patients and 4 PD or less vertically in 87% of patients when compared with the alignment in the operating room. Diplopia, if present, resolved in 85% of patients. One patient (6.7%) required a second surgery. The mean drift at 2 weeks horizontally was 1.87 PD esotropic (range, -6 PD exophoric to 18 PD esotropic) and vertically 0.94 PD (range, -4 PD hypotropic to 4 PD hypertropic). The mean drift at 6 weeks horizontally was -0.27 PD exotropic (range, -8 PD exophoric to 8 PD esotropic) and vertically 0.6 PD (range, -6 PD hypotropic to 10 PD hypertropic). CONCLUSION: The immediate postoperative adjustment of sutures in strabismus surgery may be accurately performed using this new anesthetic technique.