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.
Introduction
To characterize the reduction in intraocular pressure (IOP) and IOP-lowering medication use following goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade as ...a stand-alone procedure in adult eyes with glaucoma uncontrolled on a regimen of 1–3 topical IOP-lowering medications.
Methods
In this retrospective analysis, data from consecutive patients undergoing goniotomy with the Kahook Dual Blade by 11 surgeons were analyzed. Preoperative, intraoperative, and postoperative follow-up data through 6 months of follow-up were collected. The primary efficacy endpoint was IOP reduction from preoperative baseline; reduction in IOP-lowering medication use was a secondary endpoint.
Results
Data were collected from 53 eyes of 42 subjects. Mean (± SE) preoperative IOP was 23.5 ± 1.1 mmHg, and from day 1 through 6 months of postoperative follow-up mean IOP reductions of 7.0–10.3 mmHg (29.8–43.8%;
p
< 0.001 at each time point) were observed. Mean preoperative medication use was 2.5 ± 0.2 medications per eye and was reduced by month 6 to 1.5 ± 0.2 (a 40.0% reduction;
p
< 0.05). Eyes with higher baseline IOP experienced mean IOP reductions of 13.7 mmHg (− 46.4%) at month 6, while eyes with lower baseline IOP experienced mean IOP reductions of 3.8 mmHg (− 21.0%) at month 6. Mean medications were reduced by 1.3 medications in high-IOP eyes and by 0.9 in low-IOP eyes at month 6. No significant sight-threatening adverse events were observed.
Conclusions
Goniotomy via trabecular meshwork excision performed using the Kahook Dual Blade effectively and safely lowered IOP when performed as a stand-alone procedure in eyes with glaucoma. The significant drop in IOP met or exceeded the recommended targets for these glaucoma patients.
Funding
New World Medical, Inc.
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.
Purpose 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). Setting Private Practice, Sioux Falls, South Dakota, USA. Design Retrospective consecutive case series. Methods 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. Results 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. Conclusions 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.
To investigate the long-term safety and efficacy of an iStent trabecular microbypass stent in combination with cataract surgery in eyes with primary open-angle glaucoma (POAG).
Private practice; ...Sioux Falls, South Dakota.
Retrospective, consecutive case series.
This case series included eyes implanted with a single trabecular microbypass stent in combination with phacoemulsification in patients with mild to severe POAG. Data were collected preoperatively and at day 1, week 1, month 1, and up to 6 years postoperatively. Primary outcome measures included mean intraocular pressure (IOP) and number of glaucoma medications. Safety was noted by assessing the incidence of IOP spikes and need for additional surgery.
The study comprised 411 eyes. Mean IOP was reduced to 14.9±4.2 mmHg compared to 18.8±5.6 mmHg at baseline at 6 years postoperative. The mean number of medications was reduced to 1.2±1.0 from 1.4±1.1 at baseline. In eyes with severe stage of disease, there was a mean IOP reduction >6 mmHg at 6 years postoperative. Eyes with baseline IOP ≥18 mmHg achieved a more robust reduction in IOP. Fifteen eyes underwent a secondary glaucoma procedure. There were no intra- or postoperative complications.
Trabecular microbypass stent implantation in combination with cataract surgery provides a sustained IOP reduction in eyes with mild-to-severe POAG. The degree of IOP reduction was more significant in eyes with higher baseline IOP and severe stage of disease.
Corneal hysteresis (CH) is used to determine the level of risk of patients developing glaucoma, categorized as suspect, mild, moderate and severe.
This is a retrospective review of 126 consecutive ...eyes presenting, for the first time, at a glaucoma subspecialty clinic. All eyes at initial examination underwent measurement of CH and intraocular pressure using the Goldmann applanation tonometry (IOPgat). Eyes were classified as CH<10 (n=51) or CH≥10 (n=75) and categorized into glaucoma suspect, mild, moderate, or severe glaucoma based on 24-2 Humphrey visual field testing. Additional data included number of topical glaucoma medications.
Of the eyes classified as a CH<10, 45.5% had moderate or severe glaucoma, and 11.8% of eyes with a CH≥10 had moderate or severe glaucoma. In the CH≥10 group, the mean IOPgat was 19.5 mmHg ± 4.72 mmHg (
<0.01) on 1 ± 1.26 (
<0.01) medications in the moderate/severe glaucoma group and 20.13 mmHg ± 4.95 mmHg (
<0.01) on 0.60 ± 0.95 (
<0.01) medications in the glaucoma suspect/mild glaucoma group. In the CH<10 group, mean IOPgat was 20.47 mmHg ± 7.56 mmHg (
<0.01) on 1.79 ± 1.17 (
<0.01) medications in the moderate/severe glaucoma group. Mean IOPgat was 17.54 mmHg ± 5.48 mmHg (
<0.01) on 0.63 ± 0.83 (
<0.01) medications in the glaucoma suspect/mild glaucoma group.
Moderate to severe glaucoma is 2.9 (
<0.01) times more likely to occur in eyes that measure a CH<10 compared to eyes that measure a CH≥10. Although not statistically significant, suspect or mild glaucoma is more common in eyes that measure a CH≥10. Eyes in the CH<10 moderate/severe glaucoma group had statistically significant higher IOPgat (
<0.01) compared to the CH<10 suspect/mild glaucoma group. Measuring CH at initial presentation can help predict the severity of glaucoma.
Purpose To evaluate some possible causes for residual astigmatism after toric intraocular lens (IOL) implantation based on an analysis of data from an online toric IOL back-calculator. Design ...Retrospective data review. Methods An online toric back-calculator was designed to allow users to input preoperative toric planning information along with postoperative IOL orientation and refractive results. These were then used to determine the optimum orientation of the IOL to reduce refractive astigmatism. The collected aggregate data were extracted from this calculator to investigate the associated reasons for residual astigmatic refractive error with toric IOLs. Results The study analyzed 12 812 records with a mean postoperative refractive astigmatism of 1.89 diopters (D). Refractive astigmatism was significantly higher with higher IOL cylinder power ( P < .01) but was not different by IOL manufacturer. Ninety percent of IOLs were not at the ideal orientation, despite 30% being at the preoperative calculated orientation. Misalignment showed a directional bias for some IOLs but not for others. The mean calculated percentage reduction in residual cylinder after reorientation was 50% ± 31% (SD), with the magnitude of residual astigmatism after IOL reorientation expected to be 0.50 D or less in 37% of eyes (4835/12 812). Expected outcomes were significantly different by IOL type. Conclusions Analysis of data from the online toric back-calculator provided insights into the nature of residual astigmatism after toric IOL implantation. The reasons for residual astigmatism in this data set varied by IOL type. Financial Disclosure Proprietary or commercial disclosures are listed after the references.
To assess the relationship between axial length (AL) and intraocular lens (IOL) rotation among eyes receiving a toric IOL and subsequently entered into an online toric back-calculator database.
...Retrospective analysis of data collected online
astigmatismfix.com, a freely available online toric back-calculator where surgeons enter pre- and post-operative information to help manage residual postoperative astigmatism. Included records were deemed valid with entry of AL and IOL orientation between January 2017 and March 2019. Rotation was determined by a difference of ≥5° between pre-operative intended IOL orientation and actual post-operative IOL orientation. Frequency and magnitude of rotation are presented with means and associated standard deviation (SD). Linear regression models of this association are presented.
Records of 6752 eyes were included in the analysis, of which 74.8% were determined to have a rotated IOL. The magnitude of rotation increased with each millimeter (mm) increase in AL with a mean rotation of 13.3° (SD: 12.8°) for eyes with AL 20-20.9 mm and a maximum mean rotation of 30.6° (SD: 30.3°) among eyes with AL 29-29.9 mm. General linear modeling demonstrated a significant association (
<0.0001) with a parameter estimate of 1.19 (standard error: 0.159) and
of 0.0083.
Analysis from an online database indicates that toric IOLs inserted into eyes with longer AL are more likely to rotate and to rotate more degrees from the target axis. The findings from this study are clinically relevant for surgeons implanting toric IOLs.
The objective of this series is to report the early post-operative visual outcomes of a novel triple procedure utilizing Descemet membrane endothelial keratoplasty (DMEK) plus light adjustable lens ...(LAL) in two patients (four eyes).
Two patients with bilateral, visually significant cataracts and Fuchs’ dystrophy were selected for DMEK plus LAL triple procedure. Patient B also exhibited a high amount of preoperative astigmatism. Both patients desired spectacle independence and were initially targeted for monovision with the dominant eye corrected for distance and the nondominant eye corrected for near. Best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), and manifest refraction were recorded at each postoperative appointment and light treatment.
In the early post-operative course, Patient A chose to pursue binocular distance correction instead of monovision. This was adjusted for accordingly using the LAL. Following final lock-in, Patient A had a distance UCVA of 20/15 in the right eye (OD) and a distance UCVA of 20/20 in the left eye (OS). Patient B was targeted for monovision. After final lock-in, Patient B had a distance UCVA of 20/15 in the dominant eye (OD) and a near UCVA of Jaeger No. 1+ in the nondominant eye (OS).
The first reported cases of DMEK plus LAL triple procedures achieved exceptional UCVA at the desired target. The post-operative customizability of the LAL allows for the achievement of excellent refractive outcomes after DMEK, even in patients with significant astigmatism and in patients who change their mind regarding refractive target.
•Two patients underwent a novel DMEK and Light Adjustable Lens (LAL) triple procedure.•Refractive outcomes were 20/15 or 20/20 uncorrected distance visual acuity.•A patient with −2 D astigmatism achieved 20/15 distance and Jaeger 1+ near monovision.•The LAL allows for post-operative flexibility and customizability in DMEK triple procedures.
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