Three-year findings of the HORIZON trial: a Schlemm canal microstent for pressure reduction in primary open angle glaucoma and cataract

OBJECTIVE: To report 3-year outcomes of the HORIZON study comparing cataract surgery with Hydrus Microstent versus cataract surgery alone. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Five hundred fifty-six eyes from 556 patients with cataract and POAG treated with ≥ 1 glaucoma medication, washed out diurnal intraocular pressure (DIOP) 22-34 mmHg and no prior incisional glaucoma surgery. METHODS: Following phacoemulsification, eyes were randomized 2:1 to receive a Hydrus® Microstent (Ivantis, Inc.) or no stent. Follow-up included comprehensive eye examinations through 3 years postoperatively. MAIN OUTCOME MEASURES: Outcome measures included IOP, medical therapy, reoperation rates, visual acuity, adverse events, and changes in corneal endothelial cell counts. RESULTS: 369 eyes were randomized to microstent treatment (HMS) and 187 to cataract surgery only (CS). Preoperative IOP, medication usage, washed out DIOP, and glaucoma severity did not differ between the two treatment groups. At 3 years, IOP was 16.7 ± 3.1 in the HMS group and 17.0 ± 3.4 in the CS group (p=0.85). The number of glaucoma medications was 0.4 ± 0.8 in the HMS group and 0.8 ± 1.0 in the CS group (p<0.001), and 73% of eyes in the HMS group were medication free compared to 48% in the CS group (p<0.001). The HMS group had a higher proportion of eyes with IOP ≤18 mmHg without medications compared to CS (56.2% vs. 34.6%, p<0.001) as well as IOP reduction of at least 20, 30 or 40 percent compared to CS alone. The cumulative probability of incisional glaucoma surgery was lower in the HMS group (0.6% vs. 3.9%, hazard ratio = 0.156, 95% CI 0.031 to 0.773, p=0.020). There was no difference in postoperative corneal endothelial cell loss between groups. There were no procedure or device related serious adverse events resulting in vision loss in either group. CONCLUSIONS: Combined cataract surgery and microstent placement for mild to moderate POAG is safe, more effective in lowering IOP with fewer medications, and less likely to result in further incisional glaucoma filtrations surgery than cataract surgery alone at 3 years

Controversies in the Use of MIGS

Abstract Minimally invasive glaucoma surgery (MIGS) has fulfilled an unmet need in the management of glaucoma. This chapter highlights some controversial issues regarding the use of MIGS in clinical practice, including (1) whether there is sufficient evidence to advocate combining MIGS with cataract surgery over cataract surgery alone, (2) the merits and drawbacks of different approaches to trabecular bypass and canal-based MIGS procedures, (3) the effect of MIGS on endothelial cell loss, (4) suprachoroidal MIGS devices and whether there is still a role for these procedures, and (5) a comparison between subconjunctival MIGS and trabeculectomy. Several questions are still left unanswered and hopefully, further research and more clinical experience with these new technologies will help improve surgical outcomes for patients

Surgical Augmentation of the Suprachoroidal Space: A Novel Material and Implant

Ticiana De Francesco,1– 3 Iqbal Ike K Ahmed3,4 1Clinica de Olhos De Francesco, Fortaleza, Brazil; 2Hospital de Olhos Leiria de Andrade (HOLA), Fortaleza, Brazil; 3John A. Moran Eye Center, University of Utah, Salt Lake City, UT, USA; 4Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, CanadaCorrespondence: Ticiana De Francesco, 499 Barao de Aracati, Fortaleza, Brazil, Tel +55 85 3219-24-25, Email [email protected]: Microinvasive glaucoma surgery (MIGS) has emerged as a safer method to lower IOP with minimal impact on patient quality of life compared to traditional glaucoma surgeries. With the advent of MIGS, there has been a renewed interest in exploring the suprachoroidal route. MIGS targeting the suprachoroidal space allow for a safe reduction in IOP while sparing conjunctiva and allowing “blebless” surgery, thus avoiding bleb-related complications. This article aims to review the rationale behind the suprachoroidal MIGS procedures and the literature surrounding the efficacy and safety of a novel suprachoroidal device, the MINIject. The available literature has shown promising IOP lowering results with the MINIject implant with a potentially safer and less invasive approach than traditional glaucoma surgeries.Keywords: suprachoroidal space, microinvasive glaucoma surgery, glaucom

Viscodilation of Schlemm&rsquo;s canal for the reduction of IOP via an ab-interno approach

Mark J Gallardo,1,2 Richard A Supnet,1 Iqbal Ike K Ahmed3 1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2University of Texas Health Sciences Center, San Antonio, TX, USA; 3Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada Purpose: The aim of this study was to compare the 1-year efficacy and safety profile of ab-interno canaloplasty (ABiC) when performed as a stand-alone procedure or as an adjunct to cataract extraction in reducing IOP and glaucoma medication dependence.Patients and methods: This retrospective, comparative, consecutive case series included patients with uncontrolled primary open-angle glaucoma (POAG) who underwent ABiC as a stand-alone procedure or in conjunction with cataract extraction. Data were collected over a 12-month period. Primary outcome measures were mean lower IOP and mean number of glaucoma medications. Secondary endpoints included surgical and postsurgical complications and secondary interventions.Results: The study included 75 eyes of 68 patients (mean age: 73.7&plusmn;9.9&nbsp;years) with a mean baseline IOP of 20.4&plusmn;4.7&nbsp;mmHg on 2.8&plusmn;0.9 medications, which reduced to 13.3&plusmn;1.9&nbsp;mmHg (n=73) on 1.1&plusmn;1.1 medications at 12 months postoperative (both P&lt;0.0001). At 12 months, 40% of eyes were medication free. In the ABiC/phacoemulsification subgroup (n=34 eyes), the mean IOP and medication use decreased from 19.4&plusmn;3.7&nbsp;mmHg on 2.6&plusmn;1.0 medications preoperatively to 13.0&plusmn;1.8&nbsp;mmHg on 0.8&plusmn;0.2 medications at 12&nbsp;months (both P&lt;0.001). In the stand-alone ABiC subgroup (n=41), the mean IOP and medication use decreased from 21.2&plusmn;5.3&nbsp;mmHg on 3.0&plusmn;0.7 medications preoperatively to 13.7&plusmn;1.9&nbsp;mmHg on 1.3&plusmn;1.1 medications at 12&nbsp;months (P=0.001 and &lt;0.001, respectively). No serious adverse events were recorded.Conclusion: These data demonstrate that ABiC was effective at reducing IOP and medication use in eyes with uncontrolled POAG with or without cataract surgery. Keywords: IOP, primary open-angle glaucoma, ab-interno canaloplasty, glaucoma medicatio

Central cortical cleanup and zonular deficiency

Ahmad M Mansour,1,2 Rafic S Antonios,1 Iqbal Ike K Ahmed3 1Department of Ophthalmology, American University of Beirut, Beirut, Lebanon; 2Department of Ophthalmology, Rafic Hariri University Hospital, Beirut, Lebanon; 3Department of Ophthalmology, University of Toronto, Toronto, ON, Canada Background: Complete removal of the cortex has been advocated to prevent posterior capsular opacification but carries the risk of zonular dehiscence, hence there is a need for a safe maximal cortical cleanup technique in eyes with severe diffuse zonulopathy in subjects above age 90. Methods: We used bimanual central cortical cleaning by elevating central fibers and aspirating them toward the periphery. Peripheral cortical fibers were removed passively only when they became loose due to copious irrigation. A one-piece foldable implant was inserted without a capsular tension ring. Postoperative corticosteroid drops were used. Results: This technique was safely performed in a dozen eyes with severe pseudo-exfoliation or brunescent cataract with weak zonules. Posterior capsular rupture, iritis, vitreous loss, and lens subluxation were not observed. Moderate capsular phimosis occurred but with maintained central vision. Conclusion: The dogma of &ldquo;complete cortical cleanup&rdquo; in severe zonulopathy needs to be revisited in favor of a clear visual axis with maximal preservation of the damaged zonules. This technique is ideal in patients above age 90 where posterior capsular opacification and late dislocation of intraocular lens&ndash;capsule bag complex are unlikely to occur until several years postoperatively. Keywords: brunescent cataract, cortex aspiration, phacoemulsification, pseudo-exfoliation, weak zonule

Circumferential viscodilation of Schlemm&rsquo;s canal for open-angle glaucoma: ab-interno vs ab-externo canaloplasty with tensioning suture

Mark J Gallardo,1,2 Richard A Supnet,1 Iqbal Ike K Ahmed3 1El Paso Eye Surgeons, PA, El Paso, TX, USA; 2Department of Ophthalmology, University of Texas Health Sciences Center in San Antonio, San Antonio, TX, USA; 3Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada Purpose: To compare the efficacy of minimally invasive ab-interno canaloplasty (ABiC) vs ab-externo canaloplasty (CP) in reducing intraocular pressure (IOP) and glaucoma medication dependence.Patients and methods: This nonrandomized, retrospective, single-center, paired eye study assessed the 12-month outcomes of 12 patients with primary open-angle glaucoma who underwent ABiC in one eye and CP in the other eye, either as stand-alone procedures or combined with cataract extraction. Primary endpoints included mean IOP and number of glaucoma medications at 12 months postoperative. Secondary endpoints included surgical complications and secondary interventions.Results: Four males and eight females with a mean age of 73.8&plusmn;12.6 years were included. In the CP group, the mean preoperative IOP was 18.1&plusmn;3.9 mmHg on 2.4&plusmn;0.5 medications, which reduced to 13.5&plusmn;2.2 mmHg (P&lt;0.05) on 0.9&plusmn;0.9 medications (P&lt;0.001). In the ABiC group, the mean preoperative IOP was 18.5&plusmn;3.4 mmHg on 2.4&plusmn;0.5 medications and postoperative IOP was 13.8&plusmn;2.2 mmHg (P&lt;0.05) on 0.8&plusmn;0.8 medications (P&lt;0.05). There was no significant difference in IOP and medication use between treatment groups at 12 months postoperative. No serious adverse events were recorded in either group, though two patients in the CP group developed pressure spikes 10 mmHg beyond preoperative IOP.Conclusion: This paired eye study found ABiC to have comparable IOP lowering and glaucoma medication reduction to CP in open-angle glaucoma. This suggests ABiC may be a suitable method for improving aqueous outflow via the trabecular pathway. Further large-scale investigation is needed. Keywords: ab-interno canaloplasty, intraocular pressure, primary open-angle glaucoma, ab-externo canaloplasty, glaucoma medications, ABiC, MIGS, canaloplast

Recommendations for the management of elevated intraocular pressure due to bleb fibrosis after XEN gel stent implantation

Vanessa Vera,1 Arsham Sheybani,2 Dan Lindfield,3 Ingeborg Stalmans,4 Iqbal Ike K Ahmed5 1Department of Glaucoma, Unidad Oftalmologica de Caracas, Caracas, Venezuela; 2Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA; 3Department of Ophthalmology, Royal Surrey County Hospital, Guildford, Surrey, UK; 4Glaucoma Unit, University Hospitals UZ Leuven, Leuven, Belgium; 5Glaucoma and Advanced Anterior Segment Surgery, University of Toronto, Toronto, ON, Canada Abstract: Surgical management of glaucoma offers a means of effective disease control. A gel stent that facilitates drainage to the subconjunctival space offers intraocular pressure (IOP) reduction similar to traditional glaucoma filtering surgeries in a less invasive manner. However, like all subconjunctival filtering procedures that result in a bleb, fibrosis can present as a cause of elevated IOP. The following proposed techniques and recommendations for managing elevated IOP due to bleb fibrosis after gel stent implantation are based on the clinical experience of the authors. The goal of this paper is to improve outcomes following gel stent surgery by providing guidance on assessment of bleb function and strategies for bleb enhancement. Keywords: glaucoma gel stent, bleb management, bleb fibrosis, glaucoma surgery, glaucoma filtering surgery, bleb needlin

Visual function, digital behavior and the vision performance index

Sarah Farukhi Ahmed,1 Kyle C McDermott,2 Wesley K Burge,2 I Ike K Ahmed,3,4 Devesh K Varma,3 Y Joyce Liao,5 Alan S Crandall,4 S Khizer R Khaderi2,61Shiley Eye Institute of Ophthalmology, University of California, San Diego, CA, USA; 2Vizzario, Inc., Venice, CA, USA; 3Ophthalmology and Vision Sciences, University of Toronto, Toronto, ON, Canada; 4Ophthalmology and Visual Sciences, University of Utah School of Medicine, Salt Lake City, UT, USA; 5Ophthalmology and Neurology, Stanford University Medical Center, Stanford, CA, USA; 6Ophthalmology, Stanford University Medical Center, Stanford, CA, USAAbstract: Historically, visual acuity has been the benchmark for visual function. It is used to measure therapeutic outcomes for vision-related services, products and interventions. Quantitative measurement of suboptimal visual acuity can potentially be corrected optically with proper refraction in some cases, but in many cases of reduced vision there is something else more serious that can potentially impact other aspects of visual function such as contrast sensitivity, color discrimination, peripheral field of view and higher-order visual processing. The measurement of visual acuity typically requires stimuli subject to some degree of standardization or calibration and has thus often been limited to clinical settings. However, we are spending increasing amounts of time interacting with devices that present high-resolution, full color images and video (hereafter, digital media) and can record our responses. Most of these devices can be used to measure visual acuity and other aspects of visual function, not just with targeted testing experiences but from typical device interactions. There is growing evidence that prolonged exposure to digital media can lead to various vision-related issues (eg, computer vision syndrome, dry eye, etc.). Our regular, daily interactions (digital behavior) can also be used to assess our visual function, passively and continuously. This allows us to expand vision health assessment beyond the clinic, to collect vision-related data in the whole range of settings for typical digital behavior from practically any population(s) of interest and to further explore just how our increasingly virtual interactions are affecting our vision. We present a tool that can be easily integrated into digital media to provide insights into our digital behavior.Keywords: vision education, visual acuity, vision assessment, technology, video games, mobile gaming, software applications, mobile application