Concept Library

The total adverse event rate for OMNI canaloplasty with or without additional Hydrus Microstent during cataract surgery was 9.09% (n=6).

Surgical success at one year was 75.8% for OMNI canaloplasty alone and 87.9% for OMNI canaloplasty with Hydrus Microstent (P=0.339) during concurrent cataract surgery.

Mean ocular hypotensive medications at one year were reduced by 47.8% in the OMNI canaloplasty alone group and by 60.0% in the OMNI canaloplasty with Hydrus Microstent group (P=0.554) during concurrent cataract surgery.

Mean intraocular pressure (IOP) at one year was reduced by 18.0% in the OMNI canaloplasty alone group and by 12.8% in the OMNI canaloplasty with Hydrus Microstent group (P=0.445) during concurrent cataract surgery.

After one year, OMNI canaloplasty with or without additional Hydrus Microstent during cataract surgery achieved comparable surgical outcomes, reductions in IOP, and medication reduction.

Implant positioning significantly affected bleb morphology and outcomes following minimally invasive bleb surgery (MIBS).

PreserFlo MicroShunt (PMS) blebs demonstrated wider fluid cavities and closer proximity to the limbus following minimally invasive bleb surgery (MIBS).

XEN Gel Stent (XGS) blebs often exhibited microcystic multiform or sub-conjunctival separation patterns following minimally invasive bleb surgery (MIBS).

Internal cavities and sub-conjunctival spaces in blebs following minimally invasive bleb surgery (MIBS) were consistently associated with lower intraocular pressure (IOP).

Surgical success following minimally invasive bleb surgery (MIBS) was associated with blebs exhibiting thicker walls, lower internal reflectivity, posterior episcleral fluid lakes, greater cystic structure density, and increased bleb height.

Late complications following the Preserflo MicroShunt implant procedure occurred less often, and device-related failure leading to secondary glaucoma surgery rarely occurred (≤ 4%) in 1001 eyes of open-angle glaucoma patients.

Early postoperative complications of the Preserflo MicroShunt implant procedure were infrequent and usually transient, with choroidal detachment (≤ 12%) and microhyphaema (10-15%) being the most common, in 1001 eyes of open-angle glaucoma patients.

The number of glaucoma medications decreased significantly after the Preserflo MicroShunt implant procedure in 1001 eyes of open-angle glaucoma patients.

At 5 years, the Preserflo MicroShunt implant procedure achieved complete success rates of 54% for IOP thresholds of 6-21 mmHg, 36% for 6-18 mmHg, and 8% for 6-14 mmHg, while qualified success rates were 62%, 38%, and 15% respectively, in 1001 eyes of open-angle glaucoma patients.

The Preserflo MicroShunt implant procedure significantly reduced intraocular pressure (IOP) from a mean baseline of 24.8 ± 8.4 mmHg to 9.6 ± 4.4 mmHg on postoperative day 1, remaining significantly reduced at 1 year (13.2 ± 3.9 mmHg) and 6 years (13.9 ± 2.3 mmHg) in 1001 eyes of open-angle glaucoma patients.

Older age and posterior tube fixation were protective factors against complete surgical failure after PRESERFLO MicroShunt (PMS) implantation across all three intraocular pressure criteria (≤ 18, ≤15, and ≤ 12 mm Hg with ≥ 20% reduction) in a multicenter Japanese cohort.

Risk factors for complete surgical failure after PRESERFLO MicroShunt (PMS) implantation across all three intraocular pressure criteria (≤ 18, ≤15, and ≤ 12 mm Hg with ≥ 20% reduction) included greater medication use and prior or concomitant cataract surgery in a multicenter Japanese cohort.

At 12-months postoperative, qualified success rates for PRESERFLO MicroShunt (PMS) implantation in a multicenter Japanese cohort were 81.0% (IOP ≤ 18 mm Hg and ≥ 20% reduction), 77.3% (IOP ≤ 15 mm Hg and ≥ 20% reduction), and 66.0% (IOP ≤ 12 mm Hg and ≥ 20% reduction).

At 12-months postoperative, complete success rates for PRESERFLO MicroShunt (PMS) implantation in a multicenter Japanese cohort were 69.5% (IOP ≤ 18 mm Hg and ≥ 20% reduction), 67.6% (IOP ≤ 15 mm Hg and ≥ 20% reduction), and 59.4% (IOP ≤ 12 mm Hg and ≥ 20% reduction).

PRESERFLO MicroShunt (PMS) implantation achieved a median intraocular pressure (IOP) reduction from 18 mm Hg preoperatively to 11 mm Hg at 12 months postoperatively, and median medication use decreased from 4 to 0 (P < .001) in a multicenter Japanese cohort.

Trabecular meshwork strip peeling (TP) during hemi-gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) significantly decreases early postoperative intraocular pressure (IOP) spikes and enhances early IOP control, while maintaining surgical success.

Trabecular meshwork strip peeling (TP) during hemi-gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) reduced the risk of intraocular pressure (IOP) spikes (odds ratio [OR], 0.01; 95% CI, 0.01-0.38; P = 0.014).

On multivariable analysis, higher baseline intraocular pressure (IOP) increased the risk of IOP spikes after hemi-gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) (odds ratio [OR], 1.48; 95% CI, 1.08-2.01; P = 0.013).

The frequency of intraocular pressure (IOP) spikes was lower with hemi-gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) with trabecular meshwork strip peeling (TP) compared to standard hemi-GATT without TP (1/14 [7.1%] vs. 10/28 [35.7%]; p = 0.048).

An intraocular pressure (IOP) spike occurred in 11/42 eyes (26.2%) after hemi-gonioscopy-assisted transluminal trabeculotomy (hemi-GATT) at 7.1  4.8 days postoperatively, lasting 6.7  5.1 days, with a mean peak IOP during spikes of 26.2  5.0 mm Hg.

The intraoperative safety of the Hydrus Microstent (HM) and triple iStent inject W devices (TiSW) was good, with no significant complications, in patients with open-angle glaucoma undergoing combined phacoemulsification.

The proportions of eyes that were medication-free at 3 years were 54.3% in the Hydrus Microstent (HM) group and 61.2% in the triple iStent inject W devices (TiSW) group among patients with open-angle glaucoma undergoing combined cataract surgery.

The 3-year reduction in mean number of medications was 1.3 in patients with open-angle glaucoma undergoing phacoemulsification combined with the Hydrus Microstent (HM) (from a total of 2.3 to 1.0) and 1.4 in those combined with triple iStent inject W devices (TiSW) (from a total of 2.2 to 0.8), with a difference of 0.1 (95% CI: -0.6, 0.8).

No significant between-group differences in estimated changes in mean intraocular pressure (IOP) from preoperative values were found at years 1, 2, and 3 (all Holm adjusted p = 1.00) between patients with open-angle glaucoma undergoing phacoemulsification combined with the Hydrus Microstent (HM) versus triple iStent inject W devices (TiSW).

At 3 years, patients with open-angle glaucoma undergoing phacoemulsification combined with triple iStent inject W devices (TiSW) showed a mean intraocular pressure (IOP) reduction of 2.0 mmHg (from 15.2 to 13.2 mmHg).

At 3 years, the mean intraocular pressure (IOP) reduction in patients with open-angle glaucoma undergoing phacoemulsification combined with the Hydrus Microstent (HM) was 2.6 mmHg (from 15.1 to 12.5 mmHg).

Short axial length (P=0.005) and postoperative hypotony (IOP ≤6 mmHg) (P=0.03) were significantly associated with ciliochoroidal detachment (CCD) following Preserflo MicroShunt (PFM) implantation.

Intraocular pressure (IOP) was significantly lower in eyes with ciliochoroidal detachment (CCD) compared to those without CCD following Preserflo MicroShunt (PFM) implantation at multiple time points: 5.9±2.9 mmHg vs. 8.3±5.0 mmHg (P=0.008) on day 1; 6.8±3.2 mmHg vs. 9.9±7.0 mmHg (P=0.02) at 1 week; 7.9±4.4 mmHg vs. 11.6±5.7 mmHg (P=0.001) at 1 month; and 2.0 mmHg vs. 11.6±4.0 mmHg (P=0.045) at 3 months.

Ciliochoroidal detachment (CCD) occurred in 56 of 83 eyes (67.5%) following Preserflo MicroShunt (PFM) implantation.

Fragility of statistically significant outcomes in randomized controlled trials of Minimally Invasive Glaucoma Surgery (MIGS) varied across device categories, with larger multicenter trials demonstrating higher fragility index (FI) values but consistently low fragility quotient (FQ) values.

In six out of sixteen (37.5%) randomized controlled trials of Minimally Invasive Glaucoma Surgery (MIGS), the fragility index (FI) was less than or equal to the number of participants lost to follow-up, suggesting vulnerability to attrition bias.

For randomized controlled trials of Minimally Invasive Glaucoma Surgery (MIGS), the mean fragility index (FI) was 9.4 ± 10.0 and the mean fragility quotient (FQ) was 0.031 ± 0.025, indicating that approximately 3% of participants would require a different outcome to render results non-significant.

Statistically significant outcomes in randomized controlled trials (RCTs) of Minimally Invasive Glaucoma Surgery (MIGS) exhibited variable statistical robustness, often due to small numbers of events, when assessed using fragility metrics.

Each patient showed individual, qualitative aqueous humour outflow (AHO) improvement after the Elios glaucoma procedure (excimer laser trabeculostomy, ELT) in six eyes of five patients undergoing cataract surgery combined with ELT.

Aqueous humour outflow (AHO) improved significantly after the Elios glaucoma procedure (excimer laser trabeculostomy, ELT) (p=0.03) overall in six eyes of five patients undergoing cataract surgery combined with ELT.

In Black patients receiving Minimally Invasive Glaucoma Surgery (MIGS) (Hydrus, iStent Inject, OMNI Surgical System) with cataract surgery, IOP reductions were greater with higher baseline IOP, and medication reductions were greater with lower baseline IOP.

In Black patients undergoing ab interno Minimally Invasive Glaucoma Surgery (MIGS) with cataract surgery or cataract surgery alone, mean IOP-lowering medication reductions were 0.4-1.0 medications across all cohorts and time points up to 24 months.

In Black patients undergoing ab interno Minimally Invasive Glaucoma Surgery (MIGS) with cataract surgery or cataract surgery alone, mean IOP reductions were in the range of 1.2-2.7 mm Hg across all cohorts and time points up to 24 months.

Minimally Invasive Glaucoma Surgery (MIGS) procedures (Hydrus, iStent Inject, OMNI Surgical System) combined with cataract surgery resulted in clinically significant reductions in intraocular pressure (IOP) and IOP-lowering medications for Black patients up to 24 months postoperatively.

Most of the Clinical Practice Guidelines for the diagnosis and management of Open Angle Glaucoma (OAG) used the GRADE approach for making recommendations, but showed variability in indications for selective laser trabeculoplasty (SLT) and minimally invasive glaucoma surgery (MIGS).

The most common interventions over three years following Preserflo MicroShunt with mitomycin-C (MMC) implantation were needling (22 cases), surgical revision (29 cases), and tube surgery (8 cases).

Common adverse events associated with the Preserflo MicroShunt with mitomycin-C (MMC) included hyphema (9 eyes), hypotony (5 eyes), and choroidal detachment (4 eyes).