Canaloplasty Group Research Articles

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

To report the 2-year efficacy and safety of penetrating canaloplasty versus ab externo canaloplasty for the treatment of primary open-angle glaucoma (POAG). A single surgical site in China. This was a prospective, randomized controlled trial. POAG patients were randomly assigned to the penetrating canaloplasty or ab externo canaloplasty group. 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). 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). Compared to ab externo canaloplasty, penetrating canaloplasty had a greater surgical success rate and better IOP reduction with a comparable rate of complications.

Long-term astigmatism after intraocular pressure sensor implantation and nonpenetrating glaucoma surgery: EYEMATE-SC trial.

To investigate long-term astigmatism after combined nonpenetrating glaucoma surgery (NPGS) and implantation of the first miniaturized suprachoroidal intraocular pressure (IOP) sensor EYEMATE-SC. The study was conducted in 5 medical centers in 2 different countries. Retrospective multicenter clinical study. Astigmatism of patients instrumented with the EYEMATE-SC IOP sensor was assessed over a follow-up period of 3 years. Refraction and corrected distance visual acuity (CDVA) were obtained preoperatively, after 6 months, 1, 2, and 3 years. A canaloplasty-operated patient cohort served as control. Astigmatism was evaluated using 3-dimensional power vector analysis involving the spherical equivalent M, and the Jackson crossed cylinder projections J 0 and J 45 . Exclusion criteria included neovascular and angle-closure glaucoma, myopia, axial length outside 22 to 26 mm, other ocular diseases, prior glaucoma surgery, other ocular surgery within 6 months (cataract surgery within 3 months) before NPGS, serious generalized conditions, and other active medical head/neck implants. Multivariate analysis indicated no changes in astigmatism along the observation period in both the EYEMATE-SC (n = 24) and the canaloplasty (n = 24) group ( P > .05 or nonsignificant after Bonferroni correction). Astigmatism was unchanged between the EYEMATE-SC and the canaloplasty group at all timepoints ( P > .05). CDVA did not change along the observation period of 3 years in each of both groups ( P > .05). Despite its suprachoroidal localization, this study indicated that the miniaturized EYEMATE-SC IOP sensor did not negatively affect long-term astigmatism after combined implantation with NPGS.

Comparison of hearing outcomes in patients with congenital aural atresia managed with canaloplasty and bone conduction hearing devices

Background Treatment options for congenital aural atresia (CAA) include canaloplasty and implantation of an osseointegrated bone conduction device (OBCD). Few studies have compared hearing outcomes in these two treatment methods. Objectives Hearing outcomes and revision surgery rates were compared in CAA patients managed by canaloplasty and surgically implanted OBCD. Methods This study retrospectively analyzed 36 patients with CAA at a single institution. The same surgeon performed canaloplasty on 23 patients. Hearing outcomes before surgery as well as 3 and 6 months after surgery were compared to those of 13 patients with OBCD implantation. Results Postoperative hearing outcomes were better in the OBCD group, but the difference was not statistically significant. At 6-month follow-up, the hearing thresholds in the canaloplasty and OBCD group were 38.6 ± 21.4 and 31.9 ± 6.4 dB, respectively. The success rates 6 months after surgery were 75.0% in the canaloplasty group and 100% in the OBCD group. Two out of 23 patients in the canaloplasty group and 7 out of 13 patients in the OBCD group underwent revision surgery. Conclusion In terms of hearing, the outcome was better with the OBCD compared to canaloplasty. Canaloplasty may be an alternative option in patients who refuse OBCD implantation.

Intermediate outcomes of ab externo circumferential trabeculotomy and canaloplasty in POAG patients with prior incisional glaucoma surgery

BackgroundTo compare the efficacy and safety of ab externo circumferential trabeculotomy (ECT) and canaloplasty on primary open angle glaucoma (POAG) patients with failed filtering surgery and intact schlemm’s canal (SC).MethodsWe conducted a retrospective chart review of POAG patients with failed filtering surgery and intact SC, who further received ECT and canaloplasty. The primary outcome measures were intraocular pressure (IOP) and the number of topical medications at each follow-up point. The secondary outcome compared the quantified success rate at1-year follow-up between the groups.ResultsTwenty-nine eyes were recruited in the ECT group and 19 eyes in canaloplasty group. The postoperative IOP and the number of topical medications decreased significantly in both groups (p < 0.001). The IOP at 3-month and 6-monthwas significantly lower in the ECT group (p = 0.039, p = 0.001) than in the canaloplasty group. Although the IOP at 12-mon was similar between the two groups, the number of topical medications was less in the ECT group (p = 0.040). Hyphema (72.4%) and ciliary body detachment (27.6%), which mainly resolve spontaneously, were two leading complications in the ECT group. The prevalence of hyphema was higher in ECT than in canaloplasty group (p < 0.001).ConclusionFor POAG with failed filtering surgery and intact SC, canaloplasty may be safer, whereas ECT presented better IOP control.Translational Relevance: Suggestions for surgical choice for POAG with failed filtering surgery.

Estimation of risk-benefit ratio and comparison of post-operative efficacy results between trabeculectomy and canaloplasty.

To estimate a risk-benefit ratio by comparing the efficacy of canaloplasty to trabeculectomy exclusively in pseudophakic eyes with primary open angle glaucoma. One hundred four eyes that underwent ab externo canaloplasty and 136 eyes that underwent trabeculectomy with mitomycin C 0.02% and collagen matrix implantation were retrospectively compared. The efficacy was evaluated by evaluating the absolute success rate (5 ⩽ intraocular pressure ⩽ 15 mmHg) and the qualified success rate (intraocular pressure ⩽15 mmHg) using the Kaplan-Meier survival analysis. A meta-analysis to evaluate the relative risk of both procedures in relation to post-operative interventions was performed. Mean intraocular pressure was significantly lower in both groups. Intraocular pressure decreased by 32.17% in the canaloplasty group and by 55.04% in the trabeculectomy group at 12 months (analysis of variance, p < 0.001). Medication use was lower in both groups (analysis of variance, p < 0.001) by the 12th month. The absolute success rate for canaloplasty was 20.19% of eyes compared to 52.21% of eyes with trabeculectomy (p < 0.0001). The qualified success rate was not statistically different between groups (p = 0.15). The relative risk ratio was not statistically different between groups (relative risk of 0.01 and weight of 49.65% for group A and relative risk of 0.0005 and weight of 50.35% for group B; p = 0.5). The hospitalization length was longer in trabeculectomy-treated patients (t-test, p < 0.0001). The trabeculectomy group showed better results in terms of absolute success rate. However, canaloplasty may provide a better risk-benefit ratio in terms of qualified success rate, hospitalization time, and required post-operative interventions, since canaloplasty yielded equal or superior results compared to trabeculectomy.

Ab interno canaloplasty combined with trabecular bypass stenting in eyes with primary open-angle glaucoma.

PurposeEvaluate outcomes of trabecular meshwork (TM) bypass (iStent® GTS100) with cataract extraction (CE) and TM-bypass + ab interno canaloplasty (CP) (VISCO360®) with CE in patients with primary open-angle glaucoma (POAG).SettingPrivate surgical center for a comprehensive ophthalmology practiceDesignRetrospective analysis of 186 eyes from 130 consecutive patients with 6 months follow-up.MethodsEligible eyes had POAG, indicated for CE, and had received CE + TM-bypass or CE + TM-bypass + CP. Exclusions: glaucomas not POAG, SLT within 6 months, or previous ALT. IOP, visual acuity, and medication use assessed at baseline, months 1, 3, and 6. Endpoints were mean reduction in IOP from baseline at 6 months, proportion with IOP reduction at 6 months of ≥20% and IOP <18 mmHg on same or fewer medications, mean medication reduction, and proportion medication independent.ResultsEighty-six eyes comprised the CE + TM-bypass + CP group; 100 eyes in the CE + TM-bypass group. At 6 months: mean IOP reduction was 2.9±3.6 mmHg for CE + TM-bypass + CP and 1.7±3.1 mmHg for CE + TM-bypass group (P<0.05); the proportion with IOP reduction of ≥20% and an IOP <18 mmHg on the same or fewer medications was 46% for CE + TM-bypass + CP and 35% for CE + TM-bypass; for both CE + TM-bypass + CP and CE + TM-bypass, mean number of medications was decreased (0.9 and 0.7, P<0.0001) with 56% and 48% off all medication. The most common AE were inflammation (6%) for CE + TM-bypass + CP group and VA loss (8%) for CE + TM-bypass.ConclusionAt six months, a greater proportion of CE + TM-bypass + CP patients achieved IOP reduction of ≥20% and an IOP <18 mmHg on the same or fewer medications than for TM-bypass + CE.

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

PurposeTo 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 methodsThis 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.ResultsFour males and eight females with a mean age of 73.8±12.6 years were included. In the CP group, the mean preoperative IOP was 18.1±3.9 mmHg on 2.4±0.5 medications, which reduced to 13.5±2.2 mmHg (P<0.05) on 0.9±0.9 medications (P<0.001). In the ABiC group, the mean preoperative IOP was 18.5±3.4 mmHg on 2.4±0.5 medications and postoperative IOP was 13.8±2.2 mmHg (P<0.05) on 0.8±0.8 medications (P<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.ConclusionThis 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.

Safety and efficacy of canaloplasty versus trabeculectomy in treatment of glaucoma.

We assess the efficacy and safety of canaloplasty and trabeculectomy for treatment of glaucoma. We searched the China National Knowledge Infrastructure, PubMed, Web of Science, and WanFang databases for potentially eligible studies. Pooled risk ratio (RR) with 95% confidence interval (CI) was calculated using random- or fixed-effect models if appropriate. Eight studies were included for meta-analysis. There was no difference in intraocular pressure at 6 months (WMD = 0.97, 95%CI: -0.48-2.41). Intraocular pressure in canaloplasty group 12 months after operation was higher than in trabeculectomy group (WMD = 1.90, 95%CI: 0.12-3.69), P < 0.05). The canaloplasty group showed higher success rate than trabeculectomy group (RR = 0.86, 95%CI: 0.77-0.97). The canaloplasty group was more likely to have hyphema (RR = 2.96, 95%CI: 1.51-5.83), P < 0.05) than trabeculectomy group (RR = 0.24, 95, CI(0.06-0.89), P < 0.05]. The incidence of and hypotony and postoperative choroid abnormalities in canaloplasty group was significantly lower than that in trabeculectomy group (RR = 0.30, 95%CI: 0.11-0.83; RR = 0.24, 95%CI: 0.09-0.66), P < 0.05). Both trabeculectomy and canaloplasty can significantly reduce the intraocular pressure in glaucoma patients at 12 months after operation, trabeculectomy leads a more marked IOP decrease than canaloplasty at the cost of a higher complication rate and more demanding for postoperative care.

Comparison of Surgical Outcomes between Canaloplasty and Schlemm's Canal Scaffold at 24 Months' Follow-Up.

The results of canaloplasty (CP) and Hydrus Microstent (HM) implantation were retrospectively compared at 24 months' follow-up in a cohort of subjects referred to our Institution for uncontrolled IOP in primary or secondary (e.g., pseudoexfoliative and pigmentary) open-angle glaucoma. The outcome was labelled as “complete” success, “qualified” success, or “failure” if, two years after surgery, the eyes operated on needed “no” hypotensive medications, “some” hypotensive medications, or further glaucoma surgery to attain the target IOP, respectively. Both CP and HM implant allowed significant IOP reductions, with comparable rate of clinical success and safety profile. A slightly (albeit not significant) better trend for a “complete” clinical success was observed in the CP group.

Quality of life following glaucoma surgery: canaloplasty versus trabeculectomy.

PurposeTo evaluate quality of life (QoL) with a new questionnaire after canaloplasty (CP) and trabeculectomy (TE).Patients and methodsWe assessed outcomes of surgery, rate of revision surgeries, patients’ mood, and influence of postoperative care on QoL, surgery interference with daily activities, and postsurgical complaints. Patients completed the QoL questionnaire 24 months after surgery.ResultsPatients who underwent CP (n=175) were compared to TE patients (n=152). In the CP group, 57% of patients expressed high satisfaction, while 41% of patients in the TE group said they were highly satisfied. The satisfaction difference was statistically significant (P=0.034). Significantly fewer second surgeries were needed after CP (8% CP versus 35% TE, P<0.001). Patients were more positive in the CP group (54% CP versus 37% TE, P<0.009). Stress related to postoperative care was lower in the CP group compared to the TE group (14% versus 46%). Difficulties with activities of daily living, such as reading, were much lower or even nonexistent after CP, and complaints like eye burning or stinging were significantly lower in the CP group.ConclusionsCompared with TE, CP is associated with less QoL impairment and higher patient satisfaction after surgery. However, long-term data on intraocular pressure reduction after surgery are needed to confirm long-term patient satisfaction with this surgery.

Comparison of Surgical Outcomes Between Canaloplasty and Trabeculectomy at 12 Months' Follow-Up

To compare operative outcomes of patients after canaloplasty and trabeculectomy through 12 months' follow-up. Retrospective, nonrandomized, comparative case series. We included 33 eyes of 33 patients who underwent canaloplasty and 46 eyes of 46 patients who underwent trabeculectomy with 12 months' of postoperative follow-up. Patients with open-angle glaucoma who underwent either canaloplasty or trabeculectomy with mitomycin C to control the intraocular pressure (IOP) between January 2007 and December 2008 were included. All surgeries were performed by a single surgeon (R.S.A.). Change in IOP, visual acuity (VA), postoperative medications, failure based on IOP (>18 or <4 mmHg at 1 year) or second operative procedure (any eye requiring reoperation) and complication rates at 12 months. There were no differences in demographics, previous surgery, or preoperative and postoperative VA between the groups. The mean percentage reduction in IOP from preoperative values at 12 months after surgery was 32% (± 22%) for the canaloplasty group compared with 43% (± 28%) for the trabeculectomy group (P = 0.072, Student t test). The median reduction in the number of medications at 12 months' follow-up was 3 in the trabeculectomy group and 2 in the canaloplasty group (P = 0.064). A higher percentage of patients treated with canaloplasty than trabeculectomy (36% vs. 20%) required postoperative medications, although this did not attain significance (P = 0.12). Failure based on IOP (IOP >18 or <4 mmHg at 12 months) was 12.1% (4/33 patients) for the canaloplasty group and 4.3% (2/46 patients) for the trabeculectomy group (P = 0.23, Fisher exact test). There was no difference in surgical failure rates between the canaloplasty (n = 5; 15%) and trabeculectomy (n = 5; 11%) groups (P = 0.74). Canaloplasty and trabeculectomy both achieved significant reduction in IOP at 12 months. Proprietary or commercial disclosure may be found after the references.

Canaloplasty for open angle glaucoma: a three years critical evaluation and comparison with viscocanalostomy

OBJECTIVE: Patients undergoing primary Canaloplasty for open angle glaucoma, under the care of the two authors, were entered into a common data base. The two authors also pooled their results at three years, from a prospective audit of patients undergoing Viscocanalostomy, from the same sites, in order to provide a comparison of the successes and complications of the two procedures. PATIENTS AND METHODS: Surgery was carried at: Warrington Hospital, Warrington, UK; Spire Cheshire Hospital, Stretton, UK; Augencentrum Porz, Cologne, Germany and University Eye Hospital Padua, Italy, between May 1997 and May 2008. Ninety seven eyes of 75 patients underwent Canaloplasty with a mean age of 67 years (range 41 to 85 years) and a mean follow up of 19 months (range 6 months to 3 years). One hundred and twenty eyes of 92 patients had undergone Viscocanalostomy with a mean age of 68 years (range 26 to 92 years) and a mean follow up of 22 months (range: 3 months to 3 years). RESULTS: There were no statistically significant differences in the mean pre-operative IOP and number of medications between groups. Both Canaloplasty and Viscocanalostomy groups showed a statistically significant reduction in IOP (t = 19.25. p < 0.05 and 15.54. p < 0.05 respectively) and number of medications (t = 21.18 p < 0.05 and 23.04 p < 0.05 respectively) from pre-operative levels. There was a statistically significant difference in favour of the Canaloplasty group in post-operative reduction of both IOP and number of medications compared with the Viscocanalostomy group (Mann-Whitney U 3940.5 and 4109.5 p = < .001 respectively). Of the 97 eyes that underwent Canaloplasty, using the criteria of success as ≤ 21 mm Hg, a success rate of 97% with medication and 92% with no medication was achieved. When success is defined at ≤ 17 mm Hg, the success rate was 87% with medication and 83% with no medication. For the 120 eyes undergoing Viscocanalostomy, using the criteria of success as ≤ 21 mm Hg, a success rate of 96% on medication and 55% with no medication was achieved. However, when success is defined at ≤ 17 mm Hg the success rate drops to 68% on medication and 42% with no medication. There was a statistically significant difference between groups in favour of the Canaloplasty group in the number of patients achieving a post-operative IOP of 17mm Hg or less (t = 2.55 p = .001). CONCLUSIONS: The results reported here show that both Viscocanalostomy and Canaloplasty are safe and effective surgical procedures for the management of Primary Open Angle Glaucoma with fewer complications than the current literature states for trabeculectomy. Moreover, when the results of these two groups of similar patients are compared, Canaloplasty produced significantly better results than Viscocanalostomy.