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.

6-Year Efficacy and Safety of iTrack Ab-Interno Canaloplasty as a Stand-Alone Procedure and Combined With Cataract Surgery in Primary Open Angle and Pseudoexfoliative Glaucoma.

PRCIS: Significant reductions in intraocular pressure (IOP) and the number of medications are sustained up to 6 years postoperatively for eyes that underwent ab-interno canaloplasty using the iTrack microcatheter, either as a stand-alone procedure or combined with cataract surgery. PURPOSE: The purpose of this study was to evaluate the long-term effectiveness of iTrack (Nova Eye Medical Inc.) ab-interno canaloplasty for reducing IOP and the number of glaucoma medications in patients with primary open angle (POAG) and pseudoexfoliative glaucoma. METHODS: A retrospective single-center consecutive case series. Patients were treated with either ab-interno canaloplasty performed as a stand-alone procedure or combined with cataract surgery and were followed for up to 6 years. iTrack was used to circumferentially catheterize and viscodilate the Schlemm canal over 360 degrees. Primary efficacy endpoints included IOP and number of glaucoma medications at 12, 24, 36, 48, 60, and 72 months after surgery. RESULTS: Twenty-seven eyes of 22 patients, with a mean age of 76.9±6.3 years, were recruited. Mean IOP was reduced significantly from 19.9±5.2 mm Hg (n=27) at baseline (no washout) to 14.6±3.3 mm Hg at the 6-year follow-up (n=18; P <0.001). The number of medications was significantly reduced from 1.9±1 at baseline to 0.9±0.9 at 6 years (n=18; P =0.005). At all time points, there was no statistical difference between POAG (n=16) and pseudoexfoliative (n=11) eyes, nor between stand-alone procedures (n=4) and those combined with phacoemulsification (n=23). At 72 months, the mean reduction in IOP was 27% while 53% in the number of medications. No serious complications were recorded. CONCLUSIONS: iTrack ab-interno canaloplasty performed as a stand-alone procedure or in combination with cataract surgery significantly reduced IOP and number of medications in patients with POAG up to 6 years after the procedure. To the authors' knowledge, this is the longest ab-interno canaloplasty follow-up available in the literature.

Four-Year Efficacy and Safety of iTrack Ab-interno Canaloplasty as a Standalone Procedure and Combined with Cataract Surgery in Open-Angle Glaucoma.

PURPOSE: To evaluate the long-term effectiveness of ab-interno canaloplasty (ABiC), performed with the iTrack microcatheter (Nova Eye Medical, Fremont, CA, USA), in reducing intraocular pressure (IOP) as well as the number of required glaucoma medications in patients with open-angle glaucoma (OAG). METHODS: In this retrospective single-center consecutive case series, 27 eyes of 21 patients (mean age 77.3 ± 5.8 years) were treated with ABiC performed as a standalone procedure or combined with cataract surgery. Patients with uncontrolled IOP OAG or controlled IOP (≤ 18 mmHg) OAG with intolerance to medications or lack of compliance were included. Patients were followed for up to 4 years following the procedure. The iTrack microcatheter was used to perform a 360-degree circumferential intubation and viscodilation of Schlemm's canal. Primary efficacy endpoints included IOP and the number of glaucoma medications at 12, 24, 36, and 48 months after surgery. RESULTS: In all eyes, mean IOP and number of glaucoma medications were significantly reduced from 19.8 ± 5.2 mmHg and 1.9 ± 1.00 at baseline to 14.6 ± 3 mmHg and 0.9 ± 0.8, respectively, at the 48-month follow-up (p < 0.001). IOP was stable from 12 months to 48 months (p > 0.005). After 48 months, 39% of the eyes required zero medications compared to 3.7% at baseline, and 72.2% of eyes required only one medication or less. Of all eyes, 77.8% recorded an IOP ≤ 17 mmHg. No serious complications were recorded. CONCLUSION: iTrack ABiC performed as a standalone procedure or in combination with cataract surgery significantly reduced IOP and number of medications in patients with OAG up to 4 years after the procedure.

Clinical outcomes of canaloplasty via an ab-interno surgical technique using the iTrack device: a narrative review.

PURPOSE: This narrative review seeks to investigate intraocular pressure (IOP), glaucoma medication dependence and safety profile of canaloplasty performed via an ab-interno surgical technique using the iTrack canaloplasty microcatheter (Nova Eye Medical). METHODS: A literature search was performed in March 2022 using MEDLINE and EMBASE to identify all papers which performed ab-interno canaloplasty using the iTrack, either combined with phacoemulsification or as a standalone procedure in primary open angle glaucoma. IOP was the primary efficacy outcome. Secondary outcomes were glaucoma medication use and safety profile. RESULTS: The search demonstrated 170 results of which 9 studies were included which totaled 365 eyes. Both IOP and number of medications were reduced at 12-24 months. IOP decreased from 20.0 ± 2.5 mmHg preoperatively to 13.8 ± 0.6 and at 14.0 ± 0.9 at 12 and 24 months; the number of medications was reduced from 2.5 ± 0.5 preoperatively to 0.8 ± 0.4 and 0.9 ± 0.6 at 12 and 24 months postoperatively. Comparable results were observed in the iTrack-alone and iTrack + phaco groups: IOP was reduced from baseline 20.5 ± 1.9 and 19.6 ± 3.0 to 14.3 ± 1.1 and 13.9 ± 1.1 24 months postoperatively respectively. CONCLUSION: This review suggests that ab-interno canaloplasty as a standalone procedure or combined with phacoemulsification using the iTrack leads to a reduction in IOP and glaucoma medication use up to 24 months postoperatively.

Can perforations of descemet's window (DW) improve the outcome of canaloplasty in open angle glaucoma?

PURPOSE: This study evaluates whether additional opening of the descemet's window (DW) in canaloplasty has a positive effect on the intraocular pressure (IOP), glaucoma medication, visual acuity and postoperative complications and further interventions within the subsequent 12 months. This study also compares the difference of myopia and non-myopia based on the respective surgical method, as well as the quality of life after surgery by means of a questionnaire. PATIENTS AND METHODS: This retrospective study included 114 patients who had a complete ophthalmic examination at baseline, as well as the first post-operative day and at 1, 3, 6, and 12 months following the procedure. The patients were divided into three groups: group 1 with intact DW (n = 35), group 2 with accidental rupture of the DW (n = 40), and group 3 with scheduled puncture of the DW (n = 39). Main outcome parameters were IOP reduction and the number of IOP-lowering medications. Intraoperative and postoperative complications were documented systematically. RESULTS: With a follow-up period of 12 months, all three groups showed statistically significant reductions in mean IOP and number of glaucoma medications as compared with preoperative values. At 12 months, group 1 (group 2/3) had a mean IOP reduction of 27.3% (33.1%/36.3%) and medication use reduction of 75% (82.6%/91.7%). Comparing the three surgical groups, there was no significant difference in terms of reduction of IOP and medication (p > 0.05) at all time points. Surgical complications were similarly rare. The number of subconjunctival blebs was statistically significantly different in the three groups (p < 0.05; group 1, 0%; group 2, 15%; group 3, 12.8%). Only in group 1, a revision after surgery was necessary in three cases. A significant difference concerning IOP, medication use, and visual acuity was not found between myopic eyes and non-myopic eyes after canaloplasty. The postop-surgical questionnaire showed that with 90.5% in group 1, 88.5% in group 2, and with 90.5% in group 3, the patients were highly satisfied with the results of surgery. CONCLUSION: The intraoperative scheduled puncture of the DW in tendency showed better but no statistically significant results after 1 year regarding lowering of the IOP, the visual acuity, and postoperative medication usage. In addition, no increased risk of complications was observed in the myopic eye after the opening of the DW.

Long-term results of up to 12 years of over 700 cases of viscocanalostomy for open-angle glaucoma.

PURPOSE: To study the safety and long-term efficacy of classic viscocanalostomy in patients with open-angle glaucoma (OAG) in different populations. METHODS: A total of 726 eyes of 726 patients from Europe or South Africa with primary OAG (POAG) and pseudoexfoliative glaucoma (PXFG) were included in this retrospective multicentre study. Complete (qualified) success was defined as an intraocular pressure (IOP) equal to or lower than 21, 18 and 16 mmHg without (with or without) medications, respectively. A failed procedure was defined if IOP was above 21 mmHg, not controllable by laser goniopuncture or medications. RESULTS: The mean IOP before surgery was 42.6 ± 14.2 mmHg for all patients, 29.6 ± 6.6 mmHg for European patients and 48.1 ± 12.9 mmHg for African patients. The follow-up time was 86.2 ± 43.1 months. Mean IOP was 15.4 ± 3.6 mmHg at 5 years, 15.5 ± 4.4 mmHg at 10 years and 16.8 ± 4.2 mmHg at 15 years. The qualified success rate for an IOP of 21, 18 or 16 mmHg or less after 5 years was 92% [95% confidence interval (CI) 0.88-0.96], 70% (95% CI 0.63-0.77) and 43% (95% CI 0.36-0.51) in European patients, and 90% (95% CI 0.87-0.93), 77% (95% CI 0.74-0.81) and 67% (95% CI 0.63-0.72) in African patients, respectively. There was no difference between the success rate for POAG and PXFG for an IOP of 21, 18 or 16 mmHg or less at 5 years (p = 0.64, p = 0.20, p = 0.22, respectively). Laser goniopuncture was performed postoperatively on a total of 127 eyes (17.7%), lowering the pressure from 23.1 ± 1.9 mmHg to 15.0 ± 2.2 mmHg. There were no significant complications, in particular, no blebitis or endophthalmitis. CONCLUSION: Viscocanalostomy produced a sustained long-term reduction of IOP with a low-risk profile in European and African patients with OAG over 12 years.

Phacoemulsification and intraocular lens implantation before, during, or after canaloplasty in eyes with open-angle glaucoma: 3-year results.

PURPOSE: To report 3-year results evaluating the effect on safety and efficacy of canaloplasty to treat open-angle glaucoma when combined with cataract surgery. PATIENTS AND METHODS: This was a retrospective subset analysis of a prospective, international, multicenter study evaluating 133 eyes of 133 adult, open-angle glaucoma patients who underwent canaloplasty with tensioning suture placement. Eighty-two phakic eyes that received canaloplasty alone were compared with 51 eyes that underwent cataract surgery before or during canaloplasty. RESULTS: Phakic eyes that received combined cataract-canaloplasty surgery (phacocanaloplasty) had a mean±SD baseline IOP of 23.5±5.2 mm Hg and mean glaucoma medication usage of 1.5±1.0 decreasing to a mean IOP of 13.6±3.6 mm Hg on 0.3±0.5 medications at 3 years postoperatively. Pseudophakic eyes undergoing canaloplasty had a mean baseline IOP of 23.9±5.2 mm Hg on a mean of 1.8±0.8 glaucoma medications decreasing to 15.6±3.5 mm Hg on 1.1±0.8 medications at 3 years. In phakic eyes, reductions in IOP were significantly greater and less postoperative IOP lowering medication was needed after undergoing phacocanaloplasty compared to eyes which had canaloplasty alone. CONCLUSIONS: Clear corneal phacoemulsification performed before or in combination with canaloplasty is a safe and effective surgical procedure to reduce IOP in adult patients with open-angle glaucoma.

Intracorneal blood removal six weeks after canaloplasty.

In a 71-year-old patient with bilateral open-angle glaucoma, intracorneal blood was found after a canaloplasty procedure in the right eye. Six weeks after surgery on ultrasound biomicroscopy examination, liquified blood and blood clots could be observed nasally in the deep corneal stroma close to the Descemet's membrane. The intracorneal blood was washed out with balanced saline solution following deep corneal incision and lamellar dissection. Descemet's membrane was reattached with air injection into the anterior chamber. Two months later, visual acuity improved to 20/50, intraocular pressure was 16 mm Hg without medication and confocal microscopy showed deep stromal folds and limited endothelial cell loss. Viscoelastic entering the cornea at Schwalbe's line and reflux of blood from the collector channels to Schlemm's canal can account for corneal hematoma. Even six weeks after canaloplasty, successful blood removal could be fulfilled without rupturing the Descemet's membrane.

Ultrasound biomicroscopy after canaloplasty: clinical study with two different units.

Canaloplasty is a recent non penetrating glaucoma surgical procedure where Schlemm's canal is dilated and trabecular meshwork distended by tensioning polypropylene suture. The aim of this study was to visualize the iridocorneal angle after the canaloplasty procedure by means of two different ultrasound biomicroscopy (UBM) units. Ten eyes of nine patients with primary open angle glaucoma (average age 62 years) underwent canaloplasty (six eyes) or canaloplasty combined with phacoemulsification and in-the-bag intraocular lens implantation (4 eyes). Both 50 MHz (Paradigm P45) and 80 MHz (i-UltraSound) systems were used. All procedures were performed by the same surgeon. UBM examination was performed 3 to 12 (mean 7 +/- 3.1) months after surgery. No, mild and good trabecular meshwork distension by suture tensioning was graded as 0, 1 and 2 according to the higher resolution 80 MHz images. Both ultrasound systems could show intrascleral lake and trabecular meshwork distension, which was graded as 0, 1 and 2 in 10%, 30% and 60% of eyes, respectively. Schlemm's canal could be imaged with the 80 MHz transducer only. The overall qualified success of canaloplasty (80%) was apparently correlated with suture tensioning (r=0.64). In our experience, after canaloplasty the 80 MHz but also 50 MHz technology can show trabecular meshwork distension. A greater number of eyes are needed to assess the correlation between intraocular pressure decrease and suture tensioning.

Canaloplasty in one eye compared with viscocanalostomy in the contralateral eye in patients with bilateral open-angle glaucoma.

PURPOSE: To compare the safety and efficacy of canaloplasty with viscocanalostomy when performed in both eyes of patients with bilateral open-angle glaucoma. PATIENTS AND METHODS: This comparative case series investigated 30 eyes of 15 adult patients with bilateral primary open-angle glaucoma who had canaloplasty performed in one eye and viscocanalostomy performed in the contralateral eye. Qualifying preoperative intraocular pressures (IOP) were at least 18 mm Hg with historical IOPs of at least 21 mm Hg. In canaloplasty, a microcatheter was used to viscodilate the full circumference of Schlemm canal in conjunction with the placement of a trabecular meshwork tensioning suture. Primary outcome measures included IOP, glaucoma medication usage, and adverse events. RESULTS: With a follow-up period of 18 months, both the canaloplasty and viscocanalostomy groups showed statistically significant reductions in mean IOP (P<0.01) and number of supplemental medications (P<0.01) as compared with preoperative values. In the canaloplasty cohort, eyes had a mean IOP of 14.5±2.6 mm Hg on 0.3±0.5 medications at 18 months postoperatively as compared with preoperative levels of 26.5±2.7 mm Hg on 2.1±1.0 medications. In the viscocanalostomy cohort, eyes had a mean IOP of 16.1±3.9 mm Hg on 0.4±0.5 medications at 18 months as compared with preoperative levels of 24.3±2.8 mm Hg on 1.9±0.8 medications (P=0.02). No patient in either cohort experienced significant complications. CONCLUSIONS: Canaloplasty and viscocanalostomy were safe and effective in the surgical management of open-angle glaucoma. Canaloplasty procedures showed superior efficacy to viscocanalostomy in the reduction of IOP (P=0.02) and both procedures demonstrated excellent safety profiles.

Canaloplasty: Three-year results of circumferential viscodilation and tensioning of Schlemm canal using a microcatheter to treat open-angle glaucoma.

PURPOSE: To report 3-year results of the safety and efficacy of canaloplasty, a procedure involving circumferential viscodilation and tensioning of the inner wall of Schlemm canal to treat open-angle glaucoma. SETTING: Multicenter surgical sites. DESIGN: Nonrandomized multicenter clinical trial. METHODS: This study comprised adult open-angle glaucoma patients having canaloplasty or combined cataract-canaloplasty surgery. Qualifying preoperative intraocular pressures (IOPs) were at least 16 mm Hg with historical IOPs of at least 21 mm Hg. A flexible microcatheter was used to viscodilate the full circumference of the canal and to place a trabecular tensioning suture. Primary outcome measures included IOP, glaucoma medication use, and adverse events. RESULTS: Three years postoperatively, all study eyes (n = 157) had a mean IOP of 15.2 mm Hg ± 3.5 (SD) and mean glaucoma medication use of 0.8 ± 0.9 compared with a baseline IOP of 23.8 ± 5.0 mm Hg on 1.8 ± 0.9 medications. Eyes with combined cataract-canaloplasty surgery had a mean IOP of 13.6 ± 3.6 mm Hg on 0.3 ± 0.5 medications compared with a baseline IOP of 23.5 ± 5.2 mm Hg on 1.5 ± 1.0 medications. Intraocular pressure and medication use results in all eyes were significantly decreased from baseline at every time point (P<.001). Late postoperative complications included cataract (12.7%), transient IOP elevation (6.4%), and partial suture extrusion through the trabecular meshwork (0.6%). CONCLUSION: Canaloplasty led to a significant and sustained IOP reduction in adult patients with open-angle glaucoma and had an excellent short- and long-term postoperative safety profile. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Canaloplasty: circumferential viscodilation and tensioning of Schlemm canal using a flexible microcatheter for the treatment of open-angle glaucoma in adults: two-year interim clinical study results.

PURPOSE: To evaluate 2-year postsurgical safety and efficacy of canaloplasty (circumferential viscodilation and tensioning of the inner wall of Schlemm canal) to treat open-angle glaucoma (OAG). SETTING: Multicenter surgical sites. METHODS: This international prospective study comprised adult OAG patients having glaucoma surgery or combined glaucoma-cataract surgery. Qualifying preoperative intraocular pressure (IOP) was at least 16 mm Hg and historical IOP, at least 21 mm Hg. The full circumference of the canal was viscodilated and a trabecular tensioning suture placed with a microcatheter. Primary outcome measures included IOP and glaucoma medication use. RESULTS: At 24 months, all 127 eyes (127 patients) had a mean IOP of 16.0 mm Hg +/- 4.2 (SD) and mean glaucoma medication use of 0.5 +/- 0.8 (baseline values 23.6 +/- 4.8 mm Hg and 1.9 +/- 0.8 medications). Eyes with canaloplasty alone had a mean IOP of 16.3 +/- 3.7 mm Hg and 0.6 +/- 0.8 medications (baseline values 23.2 +/- 4.0 mm Hg and 2.0 +/- 0.8 medications). Eyes with combined glaucoma-cataract surgery had a mean IOP of 13.4 +/- 4.0 mm Hg and 0.2 +/- 0.4 medications (baseline values 23.1 +/- 5.5 mm Hg and 1.7 +/- 1.0 medications). The IOP and medication use results at all time points were statistically significant versus baseline (P <.001). The late postoperative follow-up identified 3 patients with elevated IOP. No other serious ocular or nonocular complications were reported. CONCLUSION: Canaloplasty was safe and effective in reducing IOP in adult patients with OAG.