Historical and Contemporary Debates in Schlemm's Canal-Based MIGS.

Glaucoma is one of the primary causes of blindness worldwide. Canal opening surgery, a type of minimally invasive glaucoma surgery (MIGS) applied in cases of mild to moderate glaucoma, has gained increasing popularity in recent years due to its efficacy in reducing the intraocular pressure, its safety profile, the simplicity of its technique, and the reduced likelihood of compromised vision. Nevertheless, the existing body of histopathological studies remains insufficient for a comprehensive understanding of post-surgical wound healing. Consequently, debates persist among researchers regarding the mechanism through which Schlemm's canal opening surgery reduces the intraocular pressure, as well as the surgical techniques that may impact the outcomes and the factors influencing surgical success. As the history of MIGS is relatively short and lacks sufficient systemic reviews or meta-analyses evaluating the influence of individual factors, this review was conducted to illuminate the disparities in researchers' opinions at the current stage of research.

Efficacy and safety of penetrating canaloplasty versus ab externo canaloplasty for primary open-angle glaucoma: A randomized controlled trial.

PURPOSE: To report the 2-year efficacy and safety of penetrating canaloplasty versus ab externo canaloplasty for the treatment of primary open-angle glaucoma (POAG). SETTING: A single surgical site in China. DESIGN: This was a prospective, randomized controlled trial. POAG patients were randomly assigned to the penetrating canaloplasty or ab externo canaloplasty group. METHODS: This study enrolled POAG patients who underwent penetrating canaloplasty or ab externo canaloplasty randomly. Surgical success, intraocular pressure (IOP), number of glaucoma medications, and surgical complications were evaluated until 24 months post-operatively. Surgical success was defined as 6 mmHg ≤ IOP ≤21 mmHg with an IOP reduction ≥20%, which included qualified success (with or without medications) and complete success (without medications). RESULTS: A total of 52 eyes (45 patients) were randomly assigned to one of two groups: the penetrating canaloplasty group (PCP, n = 26) or the ab externo canaloplasty group (CP, n = 26). The probabilities of qualified success and complete success were 92.3% and 76.9%, respectively, in the PCP group and 64.1% and 52.1%, respectively, in the CP group at 24 months (p = 0.013, p = 0.042, log-rank test). The mean IOP decreased from 30.8 ± 10.7 and 28.6 ± 11.8 mmHg to 14.1 ± 3.3 mmHg in the PCP group and 22.1 ± 13.6 mmHg in the CP group at year two (p = 0.007). The PCP group also received fewer medications (0.2 ± 0.5) than did the CP group (0.7 ± 1.2) at year two (p = 0.038). Post-operative complications were similar, and the most common complications were transient IOP elevation and hyphema in the PCP group (42.3%, 46.2%) and the CP group (38.5%, 23.1%) (p > 0.05). CONCLUSIONS: Compared to ab externo canaloplasty, penetrating canaloplasty had a greater surgical success rate and better IOP reduction with a comparable rate of complications.

A Review of Canaloplasty in the Treatment and Management of Glaucoma.

Aim: To review the published literature evaluating the safety and efficacy outcomes of canaloplasty performed in the treatment of glaucoma. Background: Canaloplasty is a nonpenetrating glaucoma procedure involving combined 360° circumnavigation and viscodilation of Schlemm's canal. The procedure may be performed under an ab externo (with tensioning suture) or ab-interno (conjunctiva-sparing) approach. Given the wide variety of glaucoma procedure types and approaches, further investigation into the role of canaloplasty in ophthalmological practice is warranted. The objectives of this narrative review are to synthesize the existing literature in order to investigate indications, safety and efficacy outcomes, and the optimal place of canaloplasty in glaucoma treatment and management. Review of results: A total of 60 articles were included in this review. Both ab externo and ab-interno canaloplasty (ABiC) were found to be significantly effective at reducing intraocular pressure (IOP) and glaucoma medication burdens in patients with mild-to-moderate open-angle glaucoma (OAG). These findings remained consistent regardless of phacoemulsification status. ABiC was found to exhibit a safety profile favorable compared to trabeculectomy and comparable to minimally invasive trabecular bypass implants. Conclusion: Canaloplasty is a nonpenetrating surgical intervention that is highly effective in treating patients with mild-to-moderate OAG across a large variety of clinical scenarios. Clinical significance: These findings support the clinical use of canaloplasty in ophthalmological practice, clarify its patient profile, and compare procedural outcomes to other minimally invasive glaucoma surgery (MIGS) devices on the market. How to cite this article: Wagner IV, Towne C, Saade MC, et al. A Review of Canaloplasty in the Treatment and Management of Glaucoma. J Curr Glaucoma Pract 2024;18(2):79-85.

Comparison of Superior versus Inferior Canaloplasty and Trabeculotomy Using the OMNI Surgical System.

Purpose: To compare outcomes of ab-interno canaloplasty and trabeculotomy of the superior versus inferior angle. Patients and methods: This was a prospective, non-randomized, interventional comparison study done at the Veteran Affairs Hospital in Long Beach, California. All patients underwent cataract surgery with intraocular lens implantation combined with ab-interno canaloplasty and trabeculotomy with the OMNI Surgical System (SightSciences, Menlo Park, CA, USA), either superiorly or inferiorly. Pre- and post-operative intraocular pressure using Goldmann applanation tonometry and best corrected visual acuity were obtained and compared using paired t-tests. Patients were excluded if they had any prior intraocular surgery or prior laser trabeculoplasty procedures. Results: 38 eyes from 29 patients were analyzed. 19 eyes were included in the superior group and 19 eyes in the inferior group. Mean pre-operative IOP in the superior group was 17.6 ± 5.2 mmHg and in the inferior group was 17.6 ± 4.6 mmHg (p > 0.99). At 12 months, mean postoperative IOP for the superior group decreased 24% to 13.3 ± 2.8 mmHg while the inferior group decreased 26% to 13.1 ± 2.2 mmHg (p = 0.92). Mean preoperative medications in the superior group were 2.2 ± 1.3 and in the inferior group was 2.4 ± 1.3 (p = 0.88). At 12 months, this decreased to 1.3 ± 1.5 post-operatively in the superior group and 2.2 ± 1.6 post-operatively in the inferior group (p = 0.64). Conclusion: There was no statistical difference in efficacy between superior versus inferior canaloplasty/trabeculotomy with OMNI. Therefore, surgeons can perform the procedure in the direction that is most comfortable for them without affecting outcomes.

Long-term outcomes of canaloplasty and phaco-canaloplasty in the treatment of open angle glaucoma: a single-surgeon experience.

PURPOSE: To evaluate and compare the long-term outcomes of canaloplasty and phaco-canaloplasty in the treatment of open angle glaucoma and assess the prognostic factors associated with surgical outcome. METHODS: A 48-month retrospective analysis was performed on n = 133 open angle glaucoma eyes treated with canaloplasty and n = 57 open angle glaucoma eyes treated with phaco-canaloplasty by a single surgeon. Surgical success was defined according to six criteria, achieving a target intraocular pressure (IOP) ≤ 21, 18 or 15 mmHg on glaucoma medications (qualified success) or without any further treatment (complete success), including laser therapy or surgery. Kaplan-Meier survival analysis and Cox regression analysis were performed to evaluate surgical success and preoperative factors associated with surgical outcome. Surgical complications in the early postoperative period were compared between canaloplasty and phaco-canaloplasty. RESULTS: Canaloplasty and phaco-canaloplasty significantly reduced postoperative IOP and number of glaucoma medications (p = 0.001 for both). Phaco-canaloplasty showed higher rates of cumulative surgical success over canaloplasty, but only for target IOP ≤ 21 and ≤ 18 (p = 0.018 and p = 0.011, respectively). A preoperative number of > 4 glaucoma medications predicted surgical failure. Phaco-canaloplasty was associated with a higher rate of IOP peaks in the first month compared with canaloplasty (40.4% vs 12.7%, p = 0.000). CONCLUSION: Canaloplasty and phaco-canaloplasty demonstrated long-term efficacy in the treatment of open angle glaucoma, with phaco-canaloplasty showing higher rates of surgical success compared to canaloplasty, but not for target IOPs lower than 16 mmHg. Patients on more than 4 preoperative glaucoma medications may not be good candidates for canaloplasty and may benefit from other surgical options.

Canaloplasty and Trabeculotomy Combined With Phacoemulsification for Primary Angle-Closure Glaucoma: A Single-Surgeon Case Series.

PURPOSE: To evaluate the outcomes of combined canaloplasty and trabeculotomy with phacoemulsification for primary angle-closure glaucoma (PACG). METHODS: In this retrospective, consecutive, single-surgeon case series, we analyzed the pre- and postoperative measurements of PACG patients who had the procedure. Adverse events were recorded. The main outcomes were mean intraocular pressure (IOP) in each quartile of the follow-up year and the number of IOP-lowering medications the patients were on by the end of each quartile compared to their baseline values. RESULTS:  A total of 46 eyes from 39 PACG patients were included. The preoperative IOP and glaucoma medications taken were 19.33±6.03 mm Hg and 1.80±1.39, respectively (N=46). Postoperative IOP means (mm Hg) in the subsequent four quartiles were 14.00±3.33 (N=44), 13.44±2.83 (N=32), 14.38±2.39 (N=16), and 14.92±2.90 (N=13) (p<0.0001). The mean number of meds was 0.32±0.80, 0.22±0.42, 0.59±0.80, and 0.08±0.28 in each respective quartile (p<0.0001), while the median was 0 across all quartiles. CONCLUSIONS: Combining the OMNI surgical system with phacoemulsification led to substantial reductions in mean IOP and the number of IOP-lowering medications when compared to baseline measurements.

Ab Interno Canaloplasty and Trabeculotomy Outcomes for Mild, Moderate, and Advanced Open-Angle Glaucoma: A ROMEO Analysis.

Purpose: To determine if there was an association between severity of glaucoma and intraocular pressure (IOP) and medication (med) outcomes for patients in the ROMEO (Retrospective, Observational, Multicenter Evaluation of OMNI) study. Setting: Eleven ophthalmology practices in 8 US states. Design: Post-hoc analysis of all eyes enrolled and treated with ab interno canaloplasty and trabeculotomy in the retrospective, multicenter ROMEO study. Methods: Eyes were grouped according to visual field mean deviation (MD): mild (MD better than -6 dB), moderate (MD between -6 and -12 dB), advanced (-12 dB or worse). IOP and med outcomes at 12 months were compared across groups. Least squares regression was used to assess the relationship of MD with month 12 IOP. Outcomes for 1st and last MD deciles were compared as a sensitivity analysis. Results: One hundred and twenty-seven eyes were available for analysis including 79 mild, 42 moderate, 6 advanced. Most eyes had a reduction in IOP at Month 12 (70%) with most at 18 mmHg or less. Percentage IOP reduction was similar across the groups (mild 16.9%, moderate 18.6%, advanced 18.0%) with mean month 12 IOP between 14 and 16 mmHg. Medications were also reduced in all three groups; -0.8 (mild, P < 0.001), -0.55 (moderate, P < 0.05), and -1.0 (advanced, P = 0.139, ns). Regression analysis revealed no relationship between month 12 IOP and MD. Med reductions were observed for all groups with a reduction of 1 or more medications seen in (%, 95% CI) 69%, 59-79 (mild), 50%, 35-65 (moderate), and 60%, 21-99 (advanced). Secondary interventions tended to have greater incidence with worse MD likely reflecting lower desired IOP targets. Conclusion: Analysis of data from the ROMEO study suggests that similar meaningful IOP and med reductions can be expected across the range of disease severity studied.

A Rare Case of Postoperative Uveitis and Obstructive Peripheral Anterior Synechiae Following Combined OMNI Canaloplasty and Hydrus Microstent Implantation.

Purpose: This study seeks to highlight and explore the occurrence of uveitis with obstructive peripheral anterior synechiae (PAS) after a combined OMNI canaloplasty and Hydrus microstent implantation with phacoemulsification, particularly in a patient with a background of psoriatic arthritis. Observations: A 56-year-old male with a medical history of psoriatic arthritis (in remission for 10 years) and primary open-angle glaucoma (POAG) underwent a combined OMNI canaloplasty and Hydrus microstent with phacoemulsification. The surgical procedure was uncomplicated. However, within 2 weeks postsurgery, the patient presented with severe symptoms, including uveitis, elevated intraocular pressure (IOP), and a significant reduction in best-corrected visual acuity (BCVA). This postoperative response was unexpected, especially given the lack of any past history of uveitis in the patient. The complication, potentially influenced by the patient's history of psoriatic arthritis, led to the need for additional interventions, including the implantation of an Ahmed glaucoma valve. Conclusion: This case underscores the potential for postoperative complications, specifically uveitis with obstructive PAS, following combined OMNI canaloplasty and Hydrus microstent with phacoemulsification, especially in patients with a history of autoimmune diseases. Careful preoperative history, postoperative monitoring, and a nuanced approach to surgical planning are crucial. The association between systemic inflammatory conditions and ocular complications warrants deeper exploration to ensure optimal patient care. How to cite this article: Dossantos J, An J. A Rare Case of Postoperative Uveitis and Obstructive Peripheral Anterior Synechiae Following Combined OMNI Canaloplasty and Hydrus Microstent Implantation. J Curr Glaucoma Pract 2024;18(1):37-41.

New suture probe canaloplasty combined with suprachoroidal collagen implantation.

PURPOSE: To present the modified surgery technique of new suture probe canaloplasty with a specially prepared monofilament 4.0 polypropylene suture combined with suprachoroidal drainage (ScD) and collagen sheet implantation for non-penetrating glaucoma surgery. METHODS: Prospective study with a twelve months follow-up. A standard 4/0 polypropylene suture (ProleneTM by Ethicon; thickness: approximately 250 m) is cut and shaped with an ophthalmic knife (MANI® Crescent Knife, Mani Inc 8-3 Kiyohara Industrial Park, Utsunomiya, Tochigi 321-3231, Japan) to create a blunt end without sharp or compressed edges. This improves suture probe canaloplasty by providing a more stable and smoother probing device. Schlemm's canal is prepared using the standard technique of canaloplasty with suprachoroidal drainage. Then, instead of using the canaloplasty microcatheter or the previously published 6/0 double-helix suture, Schlemm's canal is probed with the blunt ending of the 4/0 Prolene suture. After successful 360-degree probing, a doubled 10/0 polypropylene tension suture is threaded through the tip of the 4/0 suture. The 4/0 suture is then pulled back and the 10/0 tension sutures are tied at both ends to tension Schlemm's canal. A special collagen sheet (Ologen®) is placed in suprachoroidal space, and the scleral flap is firmly sewed. RESULTS: 115 eyes were included in this prospective study. In 113 cases the Schlemm's canal could completely be probed with the suture probe and canaloplasty with ScD and collagen sheet implantation succeeded. In two cases the intervention was transformed to 360-degree suture trabeculotomy due to an intraoperative cheese-wiring. Twelve months after successful new suture probe canaloplasty with ScD and Collagen Implantation the IOP had decreased by 37.1% (from 21.6 ± 6.0 mmHg with 3.3 different IOP lowering eye drops to 13.5 ± 3.5 mmHg with 1.0 eye drops). 16 Patients did not achieve sufficient IOP levels and underwent 360-degree suture trabeculotomy during the follow-up. One patient had to be treated with further glaucoma surgery to achieve a sufficient IOP level. Complications were hyphema, postoperative IOP elevation and transient hypotony. No serious or sight-threatening complications occurred. CONCLUSION: New suture probe canaloplasty with ScD and collagen sheet implantation yields the opportunity to conduct a cost-effective canaloplasty easier and less complicated than with the previously described method with the twisted 6/0 suture. The safety profile and IOP lowering effect is comparable. In cases where complete probing fails, there is still the opportunity to switch to suture trabeculotomy over the majorly probed part of Schlemm's canal. The pressure lowering effect of the deep sclerectomy with ScD and suprachoroidal collagen sheet implant seems to have an additional impact on the sufficient pressure lowering procedure.

Prospective Study of Canaloplasty and Trabeculotomy Performed by Trainees.

Purpose: To evaluate outcomes of new adopters of the OMNI® Surgical System (Sight Sciences, Inc.) by prospectively evaluating intermediate-term outcomes of patients operated by trainees. Patients and Methods: This was a prospective study of surgeries performed by trainees on patients with open angle glaucoma undergoing simultaneous cataract surgery and ab interno canaloplasty and trabeculotomy using the OMNI Surgical System. Pre-operative intraocular pressure (IOP) and number of glaucoma medications were recorded. Only patients with a minimum of 6-month follow up were included. Baseline IOP was used to separate subjects into two groups: Group 1 (IOP ≥18 mmHg) and Group 2 (IOP <18 mmHg). Mean decrease in IOP and medications was calculated and compared with paired t-tests for the overall sample as well as the subgroups. Success was defined as those with a ≥20% reduction from pre-operative IOP or with an IOP ≤18 mmHg and ≥6 mmHg and on the same or fewer number of medications while not requiring additional surgery. Adverse events were also recorded. Results: Forty-two eyes of 31 patients were included. Mean pre-operative IOP was 17.2 ± 4.8 mmHg and mean number of medications was 2.4 ± 1.2. The primary endpoint was reached in 83.3% of patients at 12 months. IOP was reduced by 22.3% to 13.4 ± 2.4 (p<0.001). Mean number of medications decreased to 1.7 ± 1.6 (p<0.001). Group 1 mean IOP decreased 35.4% from 22.2 ± 4.6 mmHg to 14.3 ± 2.8 mmHg (p<0.001). Group 2 mean number of medications decreased from 2.3 ± 1.1 to 1.6 ± 1.5 (p<0.001). Conclusion: When operated on by the novice MIGS surgeon, the OMNI device provides effective IOP and glaucoma medication reduction with minimal adverse events. Efficacy and safety of the device in the hands of trainees was comparable to experienced glaucoma surgeons suggesting its ease of adoption.

Consistency in Standalone Canaloplasty Outcomes Using the iTrack Microcatheter.

Purpose: To study the consistency in outcomes of standalone canaloplasty performed via an ab-interno surgical technique in reducing intraocular pressure (IOP) and number of medications in uncontrolled open-angle glaucoma (OAG) eyes over a 12-month period. Methods: This retrospective multicenter case series included patients who underwent standalone canaloplasty via an ab-interno surgical technique using the iTrack microcatheter (Nova Eye, Inc., Fremont, USA) and had preoperative uncontrolled OAG (IOP≥18mmHg) along with no previous glaucoma surgery. The iTrack microcatheter is used to circumnavigate 360° and viscodilate Schlemm's canal. Consistency of IOP and medications reduction on an eye-by-eye basis were evaluated to understand the outcomes in each single eye. Results: Sixty-four eyes of 60 patients (age 71.5±13.4 years) were included. Six eyes (9%) that underwent additional glaucoma surgery were considered a failure and were subsequently excluded from analysis. At 12 months, IOP was reduced in 57 of the 58 (89%) remaining eyes; one eye had the same IOP with a reduced number of medications. Of the 57/58 eyes with a reduced IOP: 44 eyes (69%) required fewer medications; 12 eyes (19%) required the same number of medications. Of these 58 eyes, 78% of eyes had a ≥20% reduction in IOP compared to baseline; 69% eyes had a postoperative IOP ≤15 mmHg, and 86% eyes ≤18 mmHg at 12 months. Forty percent of the eyes were medication-free at 12 months compared to none at baseline. Conclusion: Canaloplasty performed via an ab-interno surgical technique as a standalone procedure consistently reduced IOP and glaucoma medications in almost all eyes.

Questioning the value of stalk drilling after external auditory canal osteoma excision: case series, literature review, and meta-analysis.

OBJECTIVES: To question the value of drilling the site of the stalk ("insertion site" or "stalk" drilling) of a pedunculated external auditory canal osteoma (EACO) in reducing recurrence. DATA SOURCES: A retrospective medical chart review of all patients treated for EACO in one tertiary medical center, a systematic literature review using Medline via "PubMed", "Embase", and "Google scholar" search, and a meta-analysis of the proportion for recurrence of EACO with and without drilling. RESULTS: The local cohort included 19 patients and the EACO origin was the anterior EAC wall in 42% and the superior EAC wall in 26%. The most common presenting symptoms were aural fullness and impacted cerumen (53% each), followed by conductive hearing loss (42%). All patients underwent post-excision canaloplasty, and one sustained EACO recurrence. Six studies suitable for analysis were identified (63 EACOs). Hearing loss, aural fullness, otalgia, and cerumen impaction were the most common clinical presentations. The most common EACO insertion site was the anterior EAC wall (37.5%), followed by the superior EAC and posterior walls (25% each). The inferior EAC wall was least affected (12.5%). There was no significant difference in recurrence between EACOs whose stalk insertions were drilled (proportion 0.09, 95% confidence interval [CI] 0.01-0.22) to the ones whose insertion was not drilled (proportion 0.05, 95% CI 0.00-0.17). The overall recurrence proportion was 0.07 (95% confidence interval 0.02-0.15). CONCLUSION: EACO insertion site drilling does not reduce recurrence and should be avoided in the absence of a definite pedicle projecting to the EAC lumen.

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

Purpose: 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. Setting: Eleven ophthalmology practices in 10 US states. Design: Non-interventional 36-month extension of the 12-month, prospective, multicenter, GEMINI study. Methods: 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. Results: 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. Conclusion: 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.

A Comparative Study to Determine Hearing Outcome in Type 1 Tympanoplasty With and Without Canaloplasty in Tubotympanic Type of Chronic Suppurative Otitis Media.

Background: Chronic suppurative Otitis Media is a common ear infection in India. Canaloplasty done with tympanoplasty helps to remove bony overhangs and provide complete visibility of fibrous annulus of tympanic membrane. Aim: 1. To determine the hearing outcome in chronic otitis media (mucosal type) patients undergoing type 1 tympanoplasty with canaloplasty. 2. To determine the hearing outcome in chronic otitis media (mucosal type) patients undergoing type 1 tympanoplasty without canaloplasty. 3. To compare the hearing outcome in the above mentioned 2 groups of patients. Materials and Methods: 56 patients of 15-60 years of age with mucosal type of Chronic otitis media, with central dry perforation and intact ossicles were included in our study. They were divided into group 1 (type 1 tympanoplasty + canaloplasty) and group 2 (type 1 tympanoplasty without canaloplasty), on alternate basis. AC, BC, Air bone gap avg was assessed via pure tone audiometry at 4 frequencies preoperatively and postoperatively at 3rd and 6th month, % closure of ABG average was calculated. Results: Type 1 tympanoplasty along with canaloplasty has better hearing improvement in pure tone audiometry compared to type 1 tympanoplasty alone, as % closure of ABG at postoperative 3rd and 6th month holds significant. Conclusion: The canaloplasty provides better surgical exposure via removing bony overhangs, aids in excellent functional outcome in the form of % closure of ABG. Hence canaloplasty is added as an adjunct to routinely performed aural surgeries to enhance hearing outcome.

Comparative Effectiveness and Safety of Two Different Trabecular MIGS Devices With and Without Ab Interno Canaloplasty in Patients with Primary Open-Angle Glaucoma.

INTRODUCTION: This study compared outcomes of the iStent inject trabecular micro-bypass system versus the Hydrus Microstent in patients with primary open-angle glaucoma (POAG). METHODS: Forty subjects (80 eyes) with POAG were included in this single-center, retrospective, contralateral-eye analysis. All patients underwent phacoemulsification with either iStent inject or Hydrus implantation in one eye and the other device in the contralateral eye, with ≥ 3-month follow-up. In 58 eyes (27 iStent inject, 31 Hydrus) the surgery also included ab interno canaloplasty (ABiC). Twelve-month outcomes included intraocular pressure (IOP), medications, and adverse events. Subgroup analyses were completed for iStent inject versus Hydrus, and with versus without ABiC. RESULTS: At 12 months versus baseline, mean IOP reduced from 16.8 ± 3.7 to 13.6 ± 2.9 (p = 0.003) in iStent inject eyes, and from 18.1 ± 4.5 to 14.9 ± 3.2 mmHg (p = 0.003) in Hydrus eyes (between-group IOP reduction p = 0.582). Mean number of glaucoma medications reduced from 1.23 ± 0.97 to 0.30 ± 0.76 (p < 0.001) in iStent inject eyes and from 1.20 ± 1.02 to 0.39 ± 0.72 (p = 0.001) in Hydrus eyes (between-group medication reduction p = 0.943). At 12 months, 82.6% of iStent inject eyes and 73.9% of Hydrus eyes were medication-free versus 20.0% preoperatively in both groups (p < 0.0001 both groups). There were no statistically significant IOP or medication differences between iStent inject and Hydrus pre- or postoperatively, both in the overall cohort and in the with/without ABiC subgroups. Outcomes also were similar between eyes with/without ABiC in the overall cohort and in the iStent inject/Hydrus subgroups. There were no adverse events in the iStent inject group; two eyes in the Hydrus group had device-related complications requiring five additional surgeries (one Hydrus repositioning, one Hydrus exchange, one Hydrus removal, two goniotomies). CONCLUSION: In this contralateral-eye comparison of iStent inject versus Hydrus, the groups had similar IOP and medication outcomes, regardless of stratification by ABiC completion. Eyes receiving Hydrus had more complications and subsequent surgeries.

The present study contributes some of the first real-world data comparing iStent inject versus Hydrus Microstent implantation in combination with cataract surgery in opposite eyes (right or left) of the same patient (i.e., contralateral-eye study). The report also includes subgroup analyses of eyes with versus without ab interno canaloplasty (ABiC). There were no significant between-group differences in mean intraocular pressure or medication burden preoperatively or postoperatively for iStent inject versus Hydrus. The intraocular pressure and medication reductions versus the groups' respective baselines were statistically similar as well. Finally, results remained similar for iStent inject versus Hydrus regardless of whether ABiC was completed, and were also similar when comparing eyes with ABiC versus without ABiC. In eyes receiving Hydrus, there was a greater incidence of complications and need for further surgery.

Safety and Efficacy of Three Modifications of Canaloplasty to Treat Open-Angle Glaucoma: 3-Year Outcomes.

BACKGROUND: This is a report of 3-year results of a prospective assessment of three modifications of canaloplasty (C): ab externo (ABeC), mini-canaloplasty (miniABeC), and ab interno (ABiC) performed concomitantly with cataract removal in subjects suffering from primary open-angle glaucoma (POAG). METHODS: Forty-eight individuals were randomized for one of the surgeries: ABeC, miniABeC, or ABiC and cataract removal-16 eyes for each group. Follow-up examinations were carried out on the day of the surgery, on days 1 and 7, after 1, 3, 6 months, and at 1, 2, and 3 years. Complete and qualified success was an IOP ≤ 15 mmHg without or with antiglaucoma eye drops, respectively. The IOP reduction of 20% or more was considered an additional success criterion. RESULTS: Within three years the probability of qualified success was ABiC and miniABeC-94%, ABeC-100%, and of complete success ABiC-75%, miniABeC-100%. At the 3-year follow-up, the median IOP decreased from 22 to 15 mmHg in the ABeC group (p = 0.001), from 22 to 15 mmHg in the miniABeC group 15 (p < 0.001), and from 21 to 15 mmHg in the ABiC group (p = 0.001) compared to the post-washout stage. The IOP dropped by 20% or more without medications in 56.2% of patients post ABiC, 68.8% post miniABeC and 75% post ABeC. The median number of antiglaucoma medications dropped in all three groups; at the 3-year follow-up, only one patient following ABeC and four subjects following miniABeC required treatment. One patient required reoperation and further intensification of topical treatment-post miniABeC. The levels of IOP, CDVA, and success probability at the 36-month follow-up showed no significant difference for individual groups. CONCLUSIONS: ABeC, miniABeC, and ABiC have significant IOP-lowering potential in individuals diagnosed with POAG at a mild to moderate stage and no history of IOP ≥ 30 mmHg with a good safety profile.

First-Generation iStent Bypass Implantation versus ab Externo Canaloplasty Combined with Phacoemulsification in Patients with Primary Open Angle Glaucoma-12-Month Follow-Up.

This prospective, non-randomized, interventional clinical study evaluated the efficacy and safety profile of first-generation iStent bypass implantation versus ab externo canaloplasty, both combined with phacoemulsification, in patients with primary open-angle glaucoma (POAG) after 12-month follow-up. A total of 138 patients with POAG and their 138 eyes (69 phaco-iStent and 69 phacocanaloplasty) were included. Postoperatively at 12 months, the mean intraocular pressure (IOP) decreased from 18.44 ± 3.88 to 15.51 ± 2.50 mmHg and from 17.20 ± 4.04 to 14.97 ± 2.37 mmHg in the phaco-iStent (PiS) and phacocanaloplasty (PC) groups, respectively (p = 0.480). In both groups, 35.7% achieved >20% IOP reduction from baseline. A total of 86% and 71.4% of the eyes were medication-free at 12 months in the PiS and PC groups, respectively. In both groups, all eyes showed improvement in best-corrected visual acuity compared with baseline and demonstrated similar safety profiles throughout the 12-month follow-up period. This study showed equal hypotensive effects of PiS and PC. Both procedures significantly reduced the IOP and the requirement for IOP-lowering medications for at least 12 months postoperatively, with no significant differences between the groups.

Alternative application of an iTrack microcatheter and canaloplasty: case report and literature review.

INTRODUCTION: Glaucoma is the leading cause of irreversible blindness worldwide. Schlemm's canal surgery using an iTrack flexible microcatheter has become popular because of its high quality-of-life issues and the growing demand for less invasive but effective procedures. The unique design of the microcatheter makes it a multimodal tool, which can be used not only in the field of antiglaucoma surgery but also as a drug delivery system to treat various conditions. AREAS COVERED: This review presents an update on the selected aspects of a drug delivery system using the iTrack microcatheter, including glaucoma gene therapy and posterior-segment diseases, both in animal models and human patients. The authors also report the case of a patient with branch retinal vein occlusion treated with suprachoroidal bevacizumab in the submacular region administered with the iTrack catheter. EXPERT OPINION: The findings presented in this study may indicate that the application of a microcatheter in open-angle glaucoma gene therapy is reasonable and can be combined with full or partial surgical canaloplasty procedures. Translation of this potential into a treatment modality would require overcoming multiple barriers.

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

Purpose: 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. Patients and Methods: 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. Results: 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. Conclusion: 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.

Ab-externo canaloplasty with and without suture in highly myopic eyes.

PURPOSE: To evaluate the effectiveness of ab-externo canaloplasty using the iTrack canaloplasty microcatheter (Nova Eye Inc, Fremont, California), with or without suture, in glaucoma patients with high myopia. METHODS: This was a prospective, single-center, single-surgeon, observational study comparing the outcomes of ab-externo canaloplasty performed with a tensioning suture (suture group) and without a tensioning suture (no-suture group) in mild to severe glaucoma patients with high myopia. Twenty-three eyes received canaloplasty as a standalone procedure, 5 in combination with phacoemulsification. Primary efficacy endpoints included intraocular pressure (IOP) and the number of glaucoma medications. Safety was assessed based on reported complications and adverse events. RESULTS: Twenty-nine eyes of 29 patients with a mean age of 61.2 ± 12.3 years; 19 eyes in the no-suture group and 10 eyes in the suture group. All eyes demonstrated a significant reduction in IOP 24 months postoperatively, from 21.9 ± 7.22 to 15.4 ± 4.86 mmHg in the suture group and from 23.8 ± 7.58 to 19.7 ± 3.68 mmHg in the no-suture group. The mean number of anti-glaucoma medications reduced from 3.1 ± 0.6 to 0.4 ± 0.7 in the suture group and 3.3 ± 0.9 to and 0.2 ± 0.6 in the no-suture group at 24 months. IOP was not significantly different at baseline between the 2 groups, but it was statistically different at 12 and 24 months. There was no statistically significant difference in the number of medications between the groups at baseline, 12 and 24 months. No serious complications were reported. CONCLUSION: Ab-externo canaloplasty performed either with or without a tensioning suture demonstrated good effectiveness in highly myopic eyes with a significant reduction in IOP and number of anti-glaucoma medications. The suture group achieved a lower postoperative IOP. However, the no-suture modification provides a similar reduction in medications with reduced tissue handling.