Canaloplasty and Trabeculotomy with the OMNI System in Patients with Open-Angle Glaucoma: Two-Year Results from the ROMEO Study.

Purpose: To provide extended safety and effectiveness follow-up for eyes treated with circumferential canaloplasty and trabeculotomy (CP+TR) that were included in the 12-month ROMEO study. Setting: Seven multi-subspecialty ophthalmology practices located in 6 states (Arkansas, California, Kansas, Louisiana, Missouri, and New York). Design: Retrospective, multicenter, IRB approved. Subjects: Eligible eyes had mild-moderate glaucoma and were treated with CP+TR with cataract surgery or as a standalone intervention. Methods: Main outcome measures were mean IOP, mean number of ocular hypotensive medications, mean change in number of medications, proportion of patients with a ≥20% reduction in IOP or with IOP ≤18 mmHg, and proportion of patients medication free. Safety outcomes were adverse events and secondary surgical interventions (SSI). Results: Eight surgeons at 7 centers contributed 72 patients stratified by pre-operative intraocular pressure (IOP); >18 mmHg (Grp1), ≤18 mmHg (Grp2). Mean follow-up of 2.1 years (min 1.4, max 3.5). 2-year IOP (SD) was 15.6 mmHg (-6.1 mmHg, -28% from baseline) on 1.4 medications (-0.9, -39%) for Grp1 with cataract surgery; 14.7 mmHg (-7.4 mmHg, -33% from baseline) on 1.6 medications (-0.7, -15%) for Grp1 standalone, 13.7 mmHg (-0.6 mmHg, -4.2%) on 1.2 medications (-0.8, -35%) for Grp2 with cataract surgery, 13.3 mmHg (-2.3 mmHg, -14.7%) on 1.2 medications (-1.0, -46%) for Grp2 standalone. The proportion of patients at 2 years with either a ≥20% IOP reduction or IOP between 6 and 18 mmHg and no increase in medication or SSI was 75% (54 of 72, 95% CI 69.9%, 80.1%). One-third of patients (24 of 72) were medication free whereas 9 of 72 were pre-surgical. No device-related adverse events during extended follow-up; 6 eyes (8.3%) required additional surgical or laser intervention for IOP control after 12 months. Conclusion: CP+TR provides effective IOP control that is sustained for 2 years or more.

Canaloplasty and trabeculotomy with the OMNI® surgical system in OAG with prior trabecular microbypass stenting.

PURPOSE: Evaluate effectiveness and safety outcomes for patients treated with canaloplasty and trabeculotomy previously treated with a trabecular microbypass stent (TBS). METHODS: Retrospective, multicenter, IRB approved study. Patients treated with TBS (iStent/iStent inject, Glaukos) and subsequently with OMNI surgical system (OSS) (Sight Sciences). From 5 practices in 5 US states. Open-angle glaucoma (OAG), minimum 3 months follow-up after OSS surgery, Pre-OSS IOP ≥ 17 mmHg on ≥ 1 medication. No glaucoma procedures between TBS and OSS. ENDPOINTS: proportion with ≥ 20% reduction in IOP, IOP between 6 and 18 mmHg, mean IOP, change in IOP, mean number of medications. Adverse events and secondary surgical interventions (SSI). Mann-Whitney rank sum test compared pre-OSS IOP and medications with follow-up. RESULTS: Twenty seven patients. Average age (SD) 72.2 (10.8), 22/27 primary OAG (82%), mean MD - 6.2 (7.0) dB. Mean IOP before OSS 22.3 (4.3) mmHg on 2.2 (1.3) medications. At last follow-up (mean 11 months) IOP was 17.2 mmHg on 1.8 medications, - 5.1 mmHg (- 23%, p < .001), - 0.4 meds (- 18%, p = .193); ≥ 20% IOP reduction (41%), IOP ≤ 18 (56%). Adverse events were non-serious. Hyphema > 1 mm (3, 11%), BCVA decrease (4, 15%), IOP spike (2, 7%). SSI (4, 15%) had higher pre-OSS IOP (23.4 mmHg) and worse MD (- 9.6 dB). CONCLUSION: Patients uncontrolled by medication and a prior TBS would once have been candidates for trabeculectomy and tube shunts. OSS offered a minimally invasive option that provided IOP control and avoidance of traditional surgery for the majority over follow-up averaging 11 months and up to 42 months.

Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.

PURPOSE: To provide safety and effectiveness outcomes 12 months postsurgically for sequential canaloplasty and trabeculotomy with the OMNI system combined with cataract surgery in mild-to-moderate open-angle glaucoma (OAG). SETTING: Eleven ophthalmology practices and surgery centers located in 8 U.S. states. DESIGN: Retrospective, multicenter, single arm. METHODS: Twelve surgeons contributed 81 patients meeting eligibility criteria: OAG, 12-month follow-up, and medicated intraocular pressure (IOP) 36 mm Hg or less on 4 or less medications preoperatively. Analysis was stratified by baseline IOP: more than 18 mm Hg (Group 1) and 18 mm Hg (Group 2) or less. Success was defined as proportion with 20% reduction or greater in IOP or IOP between 6 and 18 mm Hg (inclusive) and on the same or fewer medications without secondary surgical intervention (SSI). Other endpoints included mean IOP and medications at 12 months. Safety included corrected distance visual acuity and adverse events (AEs). RESULTS: Of the 81 patients included, primary success was met by 79% in Group 1 and 81% in Group 2. The mean IOP was reduced in Group 1 (21.9 to 15.1 mm Hg, P < .0001) and remained controlled in Group 2 (14.1 to 13.4 mm Hg, P = .3177). Medications went from 2.0 ± 1.3 to 1.1 ± 1.1 in Group 1 and from 1.6 ± 1.3 to 0.9 ± 1.2 in Group 2. AEs were typical for cataract or angle surgery: mild inflammation (11%), IOP spikes (5%), and hyphema (4%). Four patients (5%) required an SSI. CONCLUSIONS: The OMNI system provided effective IOP reduction, sustained IOP control, and meaningful medication reduction for up to 12 months postoperative.

Aqueous humor outflow facility by tonography does not change with body position.

PURPOSE: Intraocular pressure (IOP) varies with body position and previous research has indicated that most, but not all, of the variation in IOP is due to changes in episcleral venous pressure (EVP). Positional changes in other aqueous humor dynamic parameters may contribute to the change in IOP. The purpose of this study was to investigate the variation of aqueous humor outflow facility with body position changes. METHODS: Healthy volunteers, aged 24 to 45 years old, were recruited for this study. Constant weight tonography was performed using a modified electronic Schiotz tonometer in two positions: seated position, 70 degrees from horizontal with neck extended until the cornea was level with floor; and supine position. A minimum of 30 minutes was allowed between the two measurements. Tonography data were fitted to second order polynomials and values for the initial steady state IOP and the outflow facility were determined using standard tables and normograms. IOP was measured using pneumatonometry. RESULTS: Forty-two eyes from 21 subjects were studied. IOP in the sitting and supine positions were 17.8 +/- 1.7 mm Hg and 19.9 +/- 1.6 mm Hg, respectively, and were significantly different (P < 0.001). The mean outflow facility in the sitting and supine positions were 0.30 +/- 0.31 microL/mL/mm Hg and 0.28 +/- 0.09 microL/mL/mm Hg, respectively, and were not significantly different (P = 0.37). CONCLUSIONS: Aqueous humor outflow facility measured with electronic Schiotz tonography does not vary significantly between the supine and sitting positions.

American Joint Committee on Cancer classification predicts outcome of patients with lacrimal gland adenoid cystic carcinoma.

PURPOSE: To investigate whether American Joint Committee on Cancer (AJCC) classification at initial diagnosis of lacrimal gland adenoid cystic carcinoma predicts outcome of treatment on local recurrence. DESIGN: Retrospective chart review. PARTICIPANTS: Consecutive patients with adenoid cystic carcinoma of the lacrimal gland treated at 8 institutions between January 1986 and December 2007. METHODS: Clinical records, including pathology reports and imaging studies, were reviewed. MAIN OUTCOME MEASURES: AJCC classification, histologic subtype, local recurrence rate, and survival. RESULTS: AJCC classification at initial diagnosis was assessable for 53 patients and was as follows: T1N0M0, 7 patients; T2N0M0, 8 patients; T3aN0M0, 14 patients; T3aNxM0, 1 patient; T3aN0M1, 1 patient; T3bN0M0, 13 patients; T3bN0M1, 1 patient; T4aN0M0, 2 patients; T4bN0M0, 4 patients; T4bN0M1, 1 patient; and T4bNXM0, 1 patient. Thirty-eight (72%) of the 53 patients had >T3 tumors at presentation. Of the 38 patients with >T3 tumors, 20 were treated with orbital exenteration and postoperative adjuvant radiotherapy (RT), 6 were treated with orbital exenteration without RT, and 12 were treated with globe-preserving surgery (10 with RT and 2 without RT). Of the 15 patients with T3 tumors, the risk of local recurrence (in the orbit or skull base) was higher in patients treated with conservative surgery as opposed to orbital exenteration and RT. Only 4 (20%) of the 20 patients treated with orbital exenteration and RT had local recurrence, compared with 3 (50%) of the 6 patients treated with orbital exenteration without RT and 8 (67%) of the 12 patients treated with globe-preserving surgery. Overall, 17 (45%) of the 38 patients with >T3 tumors and only 1 (7%) of the 15 patients with T3 disease at initial diagnosis correlates with worse outcomes than does AJCC

Corneal abnormalities in incontinentia pigmenti: histopathological and confocal correlations.

PURPOSE: To describe the clinical presentation and histopathologic and confocal correlations in a case of incontinentia pigmenti (IP)-associated whorllike corneal epitheliopathy. METHODS: We describe the case report of a 22-year-old woman with IP and bilateral whorllike corneal epitheliopathy, with symptomatic dry eye complaints. Slit-lamp and confocal microscopic imaging confirmed that the pathology was restricted entirely within the epithelial layer. The cornea was debrided with the hopes of alleviating symptomatic eye complaints. The excised tissue was analyzed by standard light microscopy and transmission electron microscopy. RESULTS: In vivo confocal microscopic imaging (ConfoScan 3; Nidek, Fremont, CA) of both eyes showed the presence of multiple bright, round objects approximately 7-20 microm in diameter and located entirely within the epithelial layer. Hematoxylin-eosin-stained sections of the debrided tissue showed a mild disorganization of the overall epithelial architecture. Transmission electron microscopy noted various degrees of degenerating nuclei. The corneal epithelial defect of the patient's left eye healed by the fourth postoperative day. The new epithelium appeared normal, but at the 1-month examination, there was recurrence. CONCLUSIONS: Histomorphologic evaluation of the surgical specimen showed abnormal changes restricted to the epithelium in our patient. The observed changes are suggestive of a primary abnormality of cell maturation, which results in degeneration, and apoptosis as the epithelial cells migrate upward. The rapid recurrence of keratopathy clearly indicates that supportive treatment of blurred vision and secondary superficial punctate keratopathy with artificial tears, punctal plugs, and bandage contact lens are more likely to be beneficial.