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36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma.

To provide long-term intraocular pressure (IOP) and ocular hypotensive medication usage outcomes through 36 months for patients treated with canaloplasty and trabeculotomy (OMNI Surgical System) combined with cataract surgery as participants in the GEMINI study. Eleven ophthalmology practices in 10 US states. Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study. GEMINI patients had visually significant cataract, mild-to-moderate glaucoma (ICD-10 guidelines), medicated IOP <33 mmHg, and unmedicated mean diurnal IOP (DIOP) (after washout) 21-36 mmHg. Patients from GEMINI were eligible for inclusion. Outcome measures were reduction in mean unmedicated DIOP, reduction in mean IOP-lowering medications, percent of eyes with ≥20% reduction in unmedicated DIOP, and percent of eyes with unmedicated DIOP ≥6 and ≤18 mmHg. A total of 66 patients provided consent and were enrolled. Mean (SD) unmedicated DIOP was 23.1 (2.7) mmHg at baseline, 16.7 (4.1), 16.3 (3.3) at 24 and 36 months; mean reductions of 6.2 (4.1) and 6.9 (3.4) mmHg. Twelve-month IOP at the end of GEMINI was 15.6 mmHg. The proportion of eyes with ≥20% reduction in IOP was 77% and 78% (months 24 and 36) compared to 87% at month 12 from GEMINI. About 68% of patients had an IOP between 6 and 18 mmHg at 24 months and 71% at 36 months. Mean IOP-lowering medications was 1.7 at baseline, which was reduced to 0.4 (24 months, -1.3) and 0.3 (36 months, -1.4). About 74% of patients (46 of 62) were medication free at 36 months. GEMINI demonstrated 12-month effectiveness of canaloplasty and trabeculotomy with OMNI combined with cataract surgery for IOP and medication reduction in mild-to-moderate glaucoma. However, longer-term data is key to the decision making in the selection of a surgical treatment. This GEMINI extension demonstrates that the 12-month outcomes from GEMINI were sustained through 36 months.

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Real-World Outcomes of Canaloplasty and Trabeculotomy Combined with Cataract Surgery in Eyes with All Stages of Open-Angle Glaucoma.

To evaluate the long-term safety and efficacy of sequential canaloplasty and trabeculotomy combined with cataract surgery in patients with mild, moderate, and advanced open-angle glaucoma. Case records of 171 consecutive patients (171 eyes) who had undergone cataract surgery followed by canaloplasty (≥180°) and trabeculotomy (≥90°) for mild, moderate, or advanced open-angle glaucoma (Shaffer grade ≥3) using the OMNI Surgical System (Sight Sciences, Inc., Menlo Park, CA) were analyzed retrospectively. Efficacy endpoints included change in mean IOP and number of medications from baseline to postoperative 12- and 24-months for the overall dataset and stratified by each stage of glaucoma. Kaplan-Meier survival analysis of success (eyes that did not require secondary surgical interventions (SSI)) by postoperative 24 months was also performed. Postoperatively, there was a statistically significant reduction in IOP (baseline of 17.2 mmHg on 1.3 medicines reduced to 14.3 on 0.8 medicines (12 months) and 14.0 on 0.9 medicines (24 months), p<0.001 for both time points). Eyes with advanced glaucoma (N=63) maintained significant IOP reduction (17.8 mmHg on 1.6 medicines at baseline reduced to 13.6 mmHg on 1.3 medicines (12 months) and 13.0 on 1.5 medicines (24 months), p<0.001). Kaplan-Meier analysis showed a 93.0% survival probability for the avoidance of SSI at 2 years after surgery. Canaloplasty and trabeculotomy combined with cataract surgery provided effective IOP reduction for eyes with all stages of glaucoma at postoperative 12 and 24 months, and the procedure yielded a 93% survival rate for SSI avoidance at 2 years.

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Subtenon Triamcinolone Acetonide Injection with Topical Anesthesia in Pediatric Non-Infectious Uveitis.

IntroductionSubtenon triamcinolone acetonide (Kenalog®; Bristol Myers Squibb) (STA) injections are commonly used in the treatment of adults in an outpatient setting. However, publications on detailing its outpatient use, safety, and efficacy in the pediatric population are scarce.MethodsWe reviewed STA injections performed in children in the outpatient clinics at two tertiary centers from 2014 to 2020. All children were aged ≤ 18 years and had a diagnosis of non-infectious uveitis. STA injections were done using 0.5 cc (20 mg) triamcinolone injected superotemporally with only topical anesthesia. Data on the efficacy and safety of STA in treating inflammation and compiled data on visual acuity improvement and incidence of ocular complications were evaluated.ResultsForty-eight eyes in 30 patients were included. The mean age of patients was 13.1 (range 7–18) years. There were no immediate complications observed in all injections performed. At the 3-month follow-up, inflammation had improved in 85.4% of eyes, macular edema had resolved in 77.8% of eyes, and there was significant vision improvement after STA. At 6 months after STA, the incidence of ocular hypertension was 12.5% and no new cataracts had developed.ConclusionSTA injection with topical anesthesia was a well-tolerated, reasonable alternative for short-term treatment of uveitis among this pediatric population.

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The Stability of the Red Reflex Produced by Different Surgical Ophthalmic Microscopes.

The red reflex is produced when coaxial light from the retina is reflected from patient to observer, and acts as an important tool in ophthalmic surgery owing to its application in screening various ocular abnormalities associated with the cornea and iris. Visualization of these intraocular structures could improve surgeons’ ability to perform ophthalmic procedures safely. The aim of this podcast, featuring Dr. Laurence Woodard (Medical Director of Omni Eye Services, Atlanta), is to highlight the clinical utility of red reflex stability and intensity provided by nearly collimated and focused beam microscope illumination systems used in ophthalmic surgery. Quantifying red reflex intensity can be challenging due to its subjective nature. Other factors such as phacoemulsification and individual characteristics of the eye, such as pupil size or iris pigment, may affect red reflex intensity. Red reflex stability and intensity may also be altered during the procedure because of excessive eye movement, lack of centering, or if the eye is not perpendicular to the light beam. In addition, differences in nearly collimated and focused illumination systems may affect surgeon fatigue and surgery success. The intensity of the red reflex dictates surgeons’ ability to maintain adequate visualization during surgery as well as identify ocular abnormalities. In conclusion, the more intense the red reflex, the more likely a surgeon will be able to maintain adequate visualization during surgery as well as identify corneal and anterior segment abnormalities. The podcast and transcript can be viewed below the abstract of the online version of the manuscript. Alternatively, the podcast can be downloaded here: https://doi.org/10.6084/m9.figshare.14779212. The Stability of the Red Reflex Produced by Different Surgical Ophthalmic Microscopes (MP4 24363 kb)Supplementary InformationThe online version contains supplementary material available at 10.1007/s40123-021-00367-w.

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Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.

The prevalence of myopia is high and increasing. Approximately 5 billion people around the world are expected to be myopic by the year 2050. Methods to slow the progression of myopia and therefore potentially decrease the associated sight-threatening complications have been the subject of a number of investigations. A workshop, sponsored by the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists, Inc, convened myopia experts from around the world to discuss principles to consider in the design of clinical trials investigating the effectiveness and safety of myopia control devices. Experts discussed parameters such as study endpoints, duration, enrollment criteria, patient-reported outcomes, recruitment, and retention. The discussions among the experts, FDA, and audience members should help to facilitate the development and evaluation of reasonably safe and effective myopia control devices.

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A randomised controlled trial of alcohol delamination and phototherapeutic keratectomy for the treatment of recurrent corneal erosion syndrome

AimTo compare the efficacy of alcohol delamination (ALD) and phototherapeutic keratectomy (PTK) for the treatment of recurrent corneal erosion syndrome (RCES) in a prospective, randomised, controlled trial.MethodsPatients with RCES not responding to conservative treatment were recruited and randomised to undergo ALD or PTK. Patients were masked to their treatment group. The primary outcome measure was the intensity of pain on waking, using a numerical rating scale between 0 and 10 to record a subjective pain score.Results17 eyes were treated with ALD and 16 eyes were treated with PTK. The mean follow-up period was 16.25 and 17.25 months, respectively. There were no differences in baseline parameters or pain scores at 3, 6, 12 and 24 months between the groups. The pain score improved from baseline at 3 months (ALD, p=0.022; PTK, p=0.014) and 6 months (ALD, p=0.033; PTK, p=0.036) in both groups, but only in the ALD group at 24 months (ALD, p=0.035; PTK, p=0.500). Overall, there was complete or partial resolution of symptoms in 11 (65%) eyes in the ALD group and 10 (63%) eyes in the PTK group. Recurrence of symptoms was observed in five eyes in the ALD group and six eyes in the PTK group. There was one treatment failure in the ALD group. There were no long-term complications.ConclusionsALD should be considered as an alternative treatment for the management of RCES with promising results compared with PTK.

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