Product information and disease description Place of product in therapy Approaches to treatment Current treatment options and standard of care

Combined cataract and glaucoma surgery

16 evidence topics · 6 sources

AAO Preferred Practice Pattern: options for patients with POAG and visually significant cataract

“If IOP control is at target on one or two medications, cataract surgery alone may be adequate, with the additional benefit that it may lower IOP slightly.” (opens the source at this quote in a new tab)
“Cataract surgery alone consistently produces modest reductions in IOP and glaucoma medical therapy in patients with POAG.” (opens the source at this quote in a new tab)
“Patients with higher preoperative IOP generally experience greater IOP reduction with cataract extraction.” (opens the source at this quote in a new tab)
“Other types of glaucoma surgery can also be combined with cataract surgery, such as implantation of aqueous shunts, nonpenetrating glaucoma surgery, MIGS, and ECP.” (opens the source at this quote in a new tab)

European Glaucoma Society guidelines: mild to moderate glaucoma with cataract

“– IOP at or near target: Phacoemulsification alone or phacoemulsification with MIGS.” (opens the source at this quote in a new tab)
“– IOP significantly above target: Glaucoma intervention should be offered. Bleb-forming surgery with or without phacoemulsification is advisable.” (opens the source at this quote in a new tab)
“Cataract surgery alone is not recommended for controlling glaucoma, although it can modestly but consistently reduce IOP and medications in POAG, with a more pronounced effect in eyes with PXG and higher preoperative IOP values.” (opens the source at this quote in a new tab)

Cataract extraction in the OHTS observation group

“In the cataract group, postoperative IOP was significantly lower than the preoperative IOP (19.8 ± 3.2 mmHg vs. 23.9 ± 3.2 p<0.001). The postoperative IOP remained lower than preoperative IOP for at least 36 months. The average decrease in postoperative IOP from preoperative IOP was 16.5%, and 39.7% of eyes had postoperative IOP ≥ 20% below preoperative IOP.” (opens the source at this quote in a new tab)

HORIZON: Hydrus Microstent with cataract surgery, 5 years

“Three hundred sixty-nine eyes were randomized to HMS treatment, and 187 eyes were randomized to CS only.” (opens the source at this quote in a new tab)
“The number of glaucoma medications was 0.5 ± 0.9 in the HMS group and 0.9 ± 0.9 in the CS group (P < 0.001), and 66% of eyes in the HMS group were medication free compared with 46% in the CS group (P < 0.001).” (opens the source at this quote in a new tab)

iStent inject pivotal trial with cataract surgery, 2 years

“At 24 months, 75.8% of treatment eyes versus 61.9% of control eyes experienced ≥20% reduction from baseline in unmedicated DIOP (P = 0.005), and mean reduction in unmedicated DIOP from baseline was greater in treatment eyes (7.0±4.0 mmHg) than in control eyes (5.4±3.7 mmHg; P < 0.001).” (opens the source at this quote in a new tab)

HORIZON: secondary intraocular pressure-lowering procedures through 5 years

“Twenty-two events occurred in 18 eyes (4.9%) in the HMS group, and 30 events occurred in 14 eyes (7.5%) in the CS group.” (opens the source at this quote in a new tab)
“A finding of particular interest in this study is that, among a cohort of patients with predominantly mild glaucoma that was controlled with 1 or 2 topical medications, a significant proportion needed invasive glaucoma surgery over 5 years, particularly in the CS group.” (opens the source at this quote in a new tab)

HORIZON: medication count from 1 to 5 years after surgery

“From the 1-year to 5-year follow-up, the mean medication count increased by 0.2 in both groups, resulting in no change in the between-group margin over the course of the study.” (opens the source at this quote in a new tab)

HORIZON: visual acuity and visual field adverse findings through 5 years

“After 5 years, cumulative BCVA loss of 2 lines or more was 1.9% in the HMS group and 2.1% in the CS group.” (opens the source at this quote in a new tab)
“A loss of 2.5 dB or more in VF mean deviation was defined as an adverse finding in the protocol.” (opens the source at this quote in a new tab)
“This condition was met in 8.4% of HMS eyes and 9.6% of CS eyes.” (opens the source at this quote in a new tab)

HORIZON: corneal endothelial cell loss through 5 years

“The authors observed an ECL of 13% and 11% in the HMS and CS groups, respectively, at the first postoperative assessment performed at 3 months.” (opens the source at this quote in a new tab)
“Additionally, no shift toward increased ECL was found in years 4 or 5 compared with prior years.” (opens the source at this quote in a new tab)
“None of the eyes with 30% or more ECL in either group had associated corneal edema, decompensation, or other clinical sequelae.” (opens the source at this quote in a new tab)

HORIZON: medication washout schedule and its effect on later pressure comparisons

“The medication washout requirement enabled a direct assessment of the device alone on IOP not confounded by medication use but simultaneously limited the population to patients with mild and moderate severity of disease who could tolerate the washout procedure safely.” (opens the source at this quote in a new tab)
“Additionally, medication washout was not repeated after 2 years; thus, the possibility of medication introduction bias must be considered for later IOP assessments.” (opens the source at this quote in a new tab)

iStent inject pivotal trial: medication burden and drop-free proportion at 23 months

“In the treatment group, the mean number of ocular hypotensive medications was 1.6 (SD, 0.8) preoperatively and 0.4 (SD, 0.8) at 23 months, a mean reduction of 1.2 medications (SD, 1.0; P < 0.001).” (opens the source at this quote in a new tab)
“In this study, 84% of treatment eyes meeting the primary study end point were not taking ocular hypotensive medications at 23 months, compared with 67% of control eyes.” (opens the source at this quote in a new tab)

iStent inject pivotal trial: washout design and medication-free proportions at 6 and 12 months

“At the month 11 and 23 visits, subjects using ocular hypotensive medication(s) were instructed to undergo medication washout to permit unmedicated DIOP assessment at months 12 and 24, respectively.” (opens the source at this quote in a new tab)
“Eyes with secondary surgical interventions to lower IOP or other events (including loss of light perception or hypotony (IOP <6 mmHg) associated with clinically significant findings) were considered nonresponders.” (opens the source at this quote in a new tab)
“At 6 months, 81.4% of treatment subjects versus 64.1% required no additional medications or surgeries; in these subjects, mean IOP reduction was 9.2 mmHg in the treatment group and 8.2 mmHg in the control group.” (opens the source at this quote in a new tab)

iStent inject pivotal trial: intraocular pressure in medication-free eyes from 6 to 24 months

“Among medication-free eyes, the mean observed IOP from 6 to 24 months ranged from 15.4 to 17.1 mmHg for the treatment group and 15.8 to 17.8 mmHg for the control group.” (opens the source at this quote in a new tab)

iStent inject pivotal trial: visual field and cup-to-disc stability through 24 months

“Visual field MD was stable over time (mean change close to zero) from screening to 24 months in both groups.” (opens the source at this quote in a new tab)
“Mean C:D ratio also was stable over time from screening to month 24 in both groups.” (opens the source at this quote in a new tab)

iStent inject pivotal trial: endothelial cell loss through 24 months

“There was little difference in endothelial cell loss (ECL) between the treatment and control groups.” (opens the source at this quote in a new tab)
“The percentage of eyes with an ECL >30% at the 24-month visit was similar between the 2 groups (10.4% in the iStent inject group vs. 9.5% in the control group).” (opens the source at this quote in a new tab)
“In both study groups, the most substantial decline in ECD occurred within the first 3 months postoperatively (12.5% in the iStent inject group and 11.6% in the control group), and the rate of decline was minimal thereafter.” (opens the source at this quote in a new tab)

Visual field progression after cataract surgery with a microstent compared with cataract surgery alone

“In the HORIZON trial, the rate of VF progression was significantly slower in eyes that received cataract surgery in combination with the Hydrus microstent compared with the control group receiving only cataract surgery, despite similar medicated IOP in both arms.” (opens the source at this quote in a new tab)