Glaucoma remains a disease with an unclear basic pathophysiology. The optic nerve travels through two pressurized regions: the intraocular space and the intracranial space. Some authors have ...suggested that the relationship between intraocular pressure and intracranial pressure may play a fundamental role in the development of glaucoma.
Recent studies have shown that intracranial pressure is lower in patients with glaucoma and normal-tension glaucoma. Conversely, intracranial pressure appears to be elevated in patients with ocular hypertension. Early mathematical modeling studies have suggested that the counterbalance provided by intracranial pressure would be an important factor in the development of glaucoma.
The relationship between intraocular pressure and intracranial pressure may play an important role in the development of glaucoma.
To describe 12-month intraocular pressure (IOP) and medication use outcomes following excisional goniotomy (EG) as a stand-alone procedure in eyes with medically uncontrolled glaucoma.
This was a ...retrospective analysis of data from surgeons at 8 centers (6 US, 2 Mexico). Eyes with glaucoma undergoing standalone EG with a specialized instrument (Kahook Dual Blade, New World Medical, Rancho Cucamonga, CA) for IOP reduction and followed for 12 months postoperatively were included. Data were collected preoperatively, intraoperatively, and 1 day, 1 week, and 1, 3, 6, and 12 months postoperatively. The primary outcome was reduction from baseline in IOP, and key secondary outcomes included IOP-lowering medication reduction as well as adverse events.
A total of 42 eyes were analyzed, of which 36 (85.7%) had mild to severe primary open-angle glaucoma (POAG). Mean (standard error) IOP at baseline was 21.6 (0.8) mmHg, and mean number of medications used at baseline was 2.6 (0.2). At 3, 6, and 12 months postoperatively, mean IOP reductions from baseline were 4.6 mmHg (22.3%), 5.6 mmHg (27.7%), and 3.9 mmHg (19.3%) (p≤0.001 at each time point). At the same time points, mean medications reductions of 0.7 (25.8%), 0.9 (32.6%), and 0.3 (12.5%) medications were seen (p<0.05 at months 3 and 6, not significant at month 12). Six eyes (14.3%) underwent additional glaucoma surgery during the 12-month follow-up period.
Standalone EG with KDB can reduce IOP, and in many cases reduce medication use, through up to 12 months in eyes with mild to severe glaucoma. Statistically significant and clinically relevant reductions in IOP were seen at every time point. While the goal of surgery was not to reduce medication burden, mean medication use was significantly reduced at all but the last time point. In the majority of eyes, the need for a bleb-based glaucoma procedure was delayed or prevented for at least 12 months.
To identify the visual performance of radial keratotomy (RK) patients that have undergone cataract surgery with implantation of an extended depth of focus (EDOF) intraocular lens (IOL).
Retrospective ...chart review with questionnaire.
Medical charts of patients with a history of RK that had undergone phacoemulsification with implantation of the Tecnis Symfony IOL (J&J Vision) were reviewed. Data collected included preoperative demographics, number of RK incisions, pupil size, and preoperative visual acuity and manifest refraction. Primary outcome measures of the study included postoperative uncorrected distance visual acuity (UCVA) and manifest refraction spherical equivalent (SE) at each follow-up visit. Secondary outcomes included results from a telephone questionnaire assessing visual performance and satisfaction.
Twenty-four eyes of 12 patients were included. UCVA improved from an average Snellen equivalent 20/73 preoperatively to 20/33 at an average final follow-up of 6 months (
=0.0011), while average manifest SE improved from +1.68 D to -0.18 D (
<0.0001). At final follow-up, 15 of 24 eyes (62.5%) were at or within 0.5 D of target refraction, while 20 of 24 eyes (83.3%) were at or within 1.0 D. In total, 79% of eyes (19 of 24) had UCVA of 20/40 or better at distance. In the survey, 78% of patients reported satisfaction with their vision after surgery and 44% of patients reported being spectacle free for all tasks.
An EDOF lens implant can produce good visual outcomes and satisfaction in patients with a history of RK.
To evaluate the impact of trabecular microbypass stents combined with cataract surgery on refractive outcomes in patients with open-angle glaucoma (OAG).
Private practice, Sioux Falls, South Dakota, ...USA.
Retrospective, comparative case series.
Eyes with OAG had implantation of trabecular microbypass stents with concomitant cataract surgery. The unmatched control group comprised eyes that underwent only cataract extraction. Data were collected preoperatively and postoperatively for 6 months. Data included spherical equivalent (SE), astigmatic error, intraocular pressure (IOP), and number of glaucoma medications.
The series included 76 consecutive OAG eyes with combined cataract plus trabecular microbypass stent and 50 consecutive non-OAG eyes with cataract surgery only. SE outcomes were equivalent between the groups (
<0.001). For the combined and cataract-only groups respectively, 46% vs 52% had SEs within 0.25 D of the target, 80% vs 80% within 0.50 D, and 95% vs 94% within 1.00 D. Astigmatism outcomes did not significantly differ between the groups (
>0.05). As for magnitude of astigmatism in the combined and cataract only groups respectively, 51% vs 32% were within 0.5 D, 75% vs 66% within 1.0 D, 87% vs 82% within 1.5 D, and 89% vs 94% within 2.0 D. In the OAG combined-surgery group, mean intraocular pressure reduction was 3.4 mmHg (
<0.0001) at 1 month postoperatively, 4.0 mmHg (
<0.0001) at 3 months, and 3.4 mmHg (
<0.01) at 6 months. Mean decrease in number of glaucoma medications was 0.4 (
<0.05) at 1 month, 0.7 (
<0.0001) at 3 months, and 0.9 (
<0.001) at 6 months.
The results of this study suggest the trabecular microbypass stent is a refractively neutral device.
December consultation #3 Berdahl, John P
Journal of cataract & refractive surgery/Journal of cataract and refractive surgery
41, Številka:
1
Journal Article
Introduction
This study sought to assess ocular surface disease changes following cataract surgery combined with trabecular micro-bypass stent(s) implantation (iStent or iStent
inject
).
Methods
This ...prospective interventional single-arm clinical trial enrolled 47 eyes with mild-to-moderate open-angle glaucoma (OAG) on 1–4 glaucoma medications who underwent phacoemulsification and trabecular micro-bypass stent(s) implantation. Key glaucoma and ocular surface data through 3 months postoperatively included the Ocular Surface Disease Index score (OSDI), corneal/conjunctival staining (Oxford Schema), fluorescein tear break-up time (FTBUT), conjunctival hyperemia (Efron Scale), glaucoma medications, and intraocular pressure (IOP).
Results
Mean OSDI scores improved from 40.1 ± 21.6 (severe) preoperatively to 17.5 ± 15.3 (mild) at 3 months (
p
< 0.0001). While 73% of eyes had moderate or severe OSDI scores preoperatively, 29% had such scores at 3 months, and the OSDI score was normal in 57% of eyes versus 9% preoperatively. Mean FTBUT increased from 4.3 ± 2.4 s preoperatively to 6.4 ± 2.5 s at 3 months (
p
< 0.0001); mean Oxford corneal/conjunctival staining reduced from 1.4 ± 1.0 preoperatively to 0.4 ± 0.6 at 3 months (
p
< 0.0001); mean Efron conjunctival hyperemia score reduced from 1.4 ± 0.7 preoperatively to 1.2 ± 0.6 at 3 months (
p
= 0.118). The number of glaucoma medications decreased from 1.5 ± 0.9 to 0.6 ± 0.8 mean medications (60% reduction,
p
< 0.0001), with all eyes maintaining or reducing medications versus preoperatively and 55% of eyes becoming medication-free (versus 0% preoperatively). Mean IOP reduced from 17.4 ± 4.2 mmHg to 14.5 ± 3.2 mmHg (
p
< 0.0001). The safety profile was excellent.
Conclusion
Implantation of trabecular micro-bypass stent(s) (iStent or iStent
inject
) with cataract surgery produced significant improvements in ocular surface health, alongside significant reductions in IOP and medications.
Trial registration
ClinicalTrials.gov identifier, NCT04452279.
Low cerebrospinal fluid (CSF) pressure has recently been implicated in the pathogenesis of glaucoma. Although little data currently exists, various systemic parameters may affect CSF pressure. CSF ...pressure increases with increased body mass index (BMI), which corroborates recent studies that have demonstrated elevated BMI may be protective of glaucoma. CSF pressure decreases with age, while the incidence of glaucoma increases with age. Blood pressure has been reported to influence CSF pressure in some studies but not others. Women appear to have a slightly lower CSF pressure than men and CSF pressure shows diurnal fluctuation, as do blood pressure and intraocular pressure. Additionally, postural changes likely alter CSF pressure near the optic nerve. Finally, many factors that may affect CSF pressure (such as medications, genetics, race, and others) have yet to be studied conclusively.
To describe the efficacy and safety of goniotomy with trabecular meshwork excision using the Kahook Dual Blade (KDB, New World Medical Inc., Rancho Cucamonga, CA) in patients with severe or ...refractory glaucoma.
This retrospective multicentre case series reports on 40 eyes with severe or refractory open-angle glaucoma that underwent standalone or combined KDB goniotomy and were followed for 12 months post-operatively in the United-States, Mexico and Switzerland. Surgical success was defined as an intraocular pressure (IOP) reduction ≥20% from baseline at 12 months, with fewer medications than preoperatively. Mean IOP and antiglaucoma medication reduction, probabilities of achieving an IOP ≤16 or 18 mmHg, and adverse events were also analysed.
Mean IOP decreased from 18.1 ± 5.0 mmHg at baseline to 14.8 ± 3.7 mmHg at 12 months (18.2% reduction, P < 0.001). Concomitantly, the mean number of glaucoma medications decreased from 2.5 ± 1.4 to 1.7 ± 1.2 (32% reduction, P = 0.002). The proportion of eyes achieving an IOP reduction of more than 20% from baseline was 37.5% (n = 15) at 12 months. At 12 months, 67.5% and 82.5% achieved a medicated IOP ≤ 16 and ≤18 mmHg, respectively. No severe complications were reported.
Excisional goniotomy with KDB achieves a statistically significant IOP and antiglaucoma medication reduction in severe or refractory glaucoma over a period of 12 months. While its efficacy decreases with time, its favourable safety profile makes it a potentially useful primary or adjunctive procedure in high-risk eyes.
To compare the outcomes of combined microbypass stent implantation, cataract extraction, and endocyclophotocoagulation (ECP) with those of implantation of the same microbypass stent with concomitant ...cataract surgery in patients with open-angle glaucoma (OAG).
Private Practice, Sioux Falls, South Dakota, USA.
Retrospective consecutive case series.
Patients from January 2015 to August 2016 were included. The study group comprised eyes that had implantation of a microbypass stent in combination with cataract extraction and ECP. To compare outcomes, a control group of eyes with similar baseline characteristics that had implantation of a stent in combination with cataract surgery was established. Data were collected preoperatively and postoperatively at 1 day, 1 week, and 1, 3, 6, and 12 months. Data included intraocular pressure (IOP) and number of glaucoma medications.
The mean preoperative IOP was 21.49 mm Hg ± 9.56 (SD) in the study group (51 eyes) and 20.66 ± 3.23 mm Hg in the control group (50 eyes). Twelve months postoperatively, the mean IOP reduction was 7.14 mm Hg in the study group and 4.48 mm Hg in the control group and the medication reduction was 38% (0.68) and 63% (1.06), respectively.
Patients who had implantation of the microbypass stent in combination with cataract surgery and ECP had significantly better IOP reduction than those who did not have ECP. The combination procedure was also effective in patients with severe OAG.
Purpose
A randomized, double-masked, multicenter, phase 2 trial to evaluate the long-term safety and efficacy of travoprost intraocular implant, an extended-release drug delivery system designed to ...provide uninterrupted sustained intraocular pressure (IOP)-lowering therapy, thereby reducing patient treatment burden and improving adherence with IOP-lowering medication.
Methods
Patients with open-angle glaucoma or ocular hypertension were administered a fast-eluting implant (FE implant,
n
= 51) and received twice-daily (BID) placebo eye drops, a slow-eluting (SE implant,
n
= 54) and received BID placebo eye drops, or underwent a sham surgical procedure and received BID timolol 0.5% (
n
= 49). IOP was measured at baseline, day 1–2, day 10, week 4, week 6, month 3, and every 3 months thereafter through 36 months. Efficacy was evaluated by mean change from 8:00 AM unmedicated baseline IOP through month 36, and the percentage of patients receiving the same or fewer topical IOP-lowering medications as at screening (pre-study). Safety was evaluated by adverse events and ophthalmic parameters.
Results
Clinically and statistically relevant IOP-lowering treatment effects were observed through month 36 after a single administration of the travoprost implant compared with BID timolol with mean IOP reductions ranging from 7.6 to 8.8 mmHg for the FE implant group, from 7.3 to 8.0 mmHg for the SE implant group, and from 7.3 to 7.9 for the timolol group at the 8:00 AM timepoint (
P
< 0.0001 for all treatment groups at all visits). At months 12, 24, and 36, a greater percentage of FE and SE implant patients versus timolol patients were well controlled on the same or fewer topical IOP-lowering medications compared with screening with 63 and 69% for the FE and SE implants groups, respectively, versus 45% for the timolol group at month 36. The safety profile of the implant was favorable; there were no dislodgements, no explantations, no adverse events of conjunctival hyperemia or periorbital fat atrophy, no discontinuations due to study eye adverse events, nor any serious adverse events in the study eye. Comparable changes from baseline in corneal endothelial cell counts were observed in the three treatment groups over the 36 months.
Conclusion
The travoprost intraocular implant demonstrated robust IOP-lowering and substantially reduced topical IOP-lowering medication burden for up to 36 months following a single administration, while maintaining a favorable safety profile. The travoprost intraocular implant promises to be a meaningful addition to the interventional glaucoma armamentarium by addressing the key shortcomings of topical IOP-lowering medications, including low adherence and topical side effects while controlling IOP for up to 36 months.
Trial Registry
ClinicalTrials.gov identifier NCT02754596 registered 28 April 2016.
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