Purpose To evaluate the safety and efficacy of a trabecular microbypass stent (iStent) combined with cataract surgery in patients with pseudoexfoliation glaucoma (PXG). Setting Vance Thompson Vision, ...Sioux Falls, South Dakota, USA. Design Retrospective case series. Methods Eyes with PXG had implantation of 1 stent. Data were collected preoperatively and postoperatively through 24 months. Data included intraocular pressure (IOP), number of glaucoma medications, the incidence of postoperative IOP pressure spikes of 15 mm Hg or higher at any timepoint, and the need for additional surgery. Results The series included 115 eyes. The mean preoperative IOP was 20.00 mm Hg ± 6.95 (SD). One year postoperatively, the mean IOP was 15.54 ± 3.83 mm Hg ( P < .01). At 2 years, the mean IOP was 14.51 ± 2.79 ( P < .01). The mean number of glaucoma medications was 1.41 ± 1.04 preoperatively and 0.71 ± 0.94 2 years postoperatively ( P < .01), indicating a 50% reduction in medication use. Postoperatively, 7 eyes (6%) had an IOP spike of 15 mm Hg or higher above the baseline IOP; the spikes responded to topical therapy. Ninety-eight percent of patients with an IOP of 20 mm Hg or higher achieved a reduction in IOP at the last follow-up. Conclusion Trabecular microbypass stent implantation during cataract surgery safely and effectively lowered IOP and medication use in patients with mild to severe PXG.
Background:
Corneal cross-linking (CXL) is a safe and effective procedure for slowing keratectasia progression in eyes with a corneal thickness of at least 400 µm. Limited research has evaluated the ...safety and efficacy of epi-off CXL in corneas thinner than 400 µm.
Objective:
To evaluate the safety and efficacy of CXL to slow keratectasia progression in eyes with <400 µm preoperative corneal thickness.
Design:
Retrospective chart review.
Methods:
This retrospective chart review included 37 eyes who underwent epi-off, iso-osmolar riboflavin corneal CXL with a preoperative thinnest point of the cornea <400 µm and had at least 6–12 months of follow-up. Preoperative and postoperative uncorrected visual acuity, best-corrected visual acuity (BCVA), thinnest point of the cornea, flat keratometry, steep keratometry, maximum keratometry (Kmax), need for penetrating keratoplasty, and cases of endothelial failure were recorded. Data were collected at baseline and months 3, 6, 9, and 12 post-CXL.
Results:
Following cross-linking, 18 eyes (47%) had improved BCVA, 13 (35%) had an unchanged BCVA, and 6 eyes (16%) had a worse BCVA (p = 0.05). The mean postoperative BCVA was 20/81 (0.61 LogMAR) compared to 20/121 (0.78 LogMAR) preoperatively (p = 0.06). Kmax decreased an average of 1.1 D at 3-month (p = 0.53) and 3.4 D at the furthest follow-up (p = 0.10). At the farthest follow-up, 22.7% of eyes had >1 D of Kmax steepening. No patients required keratoplasty and there were no cases of endothelial failure in the follow-up period.
Conclusion:
This research supports the safety and efficacy of epi-off, iso-osmolar CXL in eyes with <400 μm baseline corneal thickness with no patients requiring penetrating or endothelial keratoplasty, a trend toward improvement in BCVA, and Kmax flattening. In the future, prospective studies would be helpful to confirm these findings.
Retrospective, consecutive case series to evaluate the implantation of two second-generation trabecular microbypass stents in combination with cataract surgery in a real-world, clinical setting.
The ...series included 56 eyes implanted with the iStent inject device with phacoemulsification. The series consisted of eyes with primary open-angle glaucoma (
= 52) and pseudoexfoliative glaucoma (
= 4). Primary outcome measures included intraocular pressure (IOP) and number of glaucoma medications. Safety outcomes included the need for secondary surgical intervention and the incidence of IOP spikes ≥10 mmHg and ≥ 15 mmHg.
IOP was reduced by 21% to 14.7 ± 2.9 mmHg (
< 0.01) at 6 months postoperative from 18.7 ± 5.8 mmHg at baseline. Preoperatively, the mean number of glaucoma medications was 1.5 ± 0.9 and reduced by 39% to 0.9 ± 1.2 (
< 0.01) at 6 months. At 6 months, 68% of eyes had an IOP ≤15 mmHg, increased from 30% at baseline. 55% of eyes were medication-free at 6 months, up from 18% at baseline. There were no severe postoperative complications. No eyes underwent an additional glaucoma procedure.
Implantation of the iStent inject device with concomitant cataract surgery effectively provides a sustained reduction in IOP with a markedly improved medication burden out to 6 months postoperative. The safety profile is excellent.
To create a defocus curve of emerging presbyopic patients of various age groups.
Single site private practice in Sioux Falls, South Dakota.
This was a non-randomized, prospective study. All subjects ...were enrolled from healthy volunteers.
Subjects aged 37-9, 40-42, 43-45 and 46-48 that have 20/20 best-corrected distance visual acuity (BCDVA) were included. Binocular visual acuity at different defocus steps ranging from +0.5 D to -3 D was measured in each age group. Defocus curves were generated from the mean logMAR visual acuities at each defocus step, by age group.
Of the 60 subjects, 23.3% of subjects were between the ages of 37-39, 26.7% were between the ages of 40-42, 25% of subjects were between ages 43-45, and 25% were between the ages of 46-48. Visual acuity significantly decreased from plano to -3 D defocus steps in all groups (p < 0.0002, p = 0, p = 0 and p = 0). The 46-48-year-old group had worse visual acuity compared to the other three groups from the -1.0 to -2.0 D defocus steps (p = 0.037, p = 0.022 and 0.017, respectively). Starting at a near point of 40cm, the 37-39 group had the best logMAR vision and the 46-48 group had the worst vision (p = 0.001).
The defocus curves of emerging presbyopic individuals demonstrate a decreasing visual acuity at near defocus steps that decreases with age. Defocus curves at different age ranges can help doctors explain various presbyopia treatment options in terms of near point capabilities at various ages.
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.
To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days.
Prospective, open-label, randomized, single-site study.
Twenty eyes of 10 ...subjects with open-angle glaucoma were fitted with an MPD and randomized to negative pressure application of -10 mmHg in one eye (study eye) worn overnight for 7 consecutive days.
Safety measures included best-corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline during and after negative pressure application, slit lamp and dilated fundus exam findings, and rate of adverse events. Subjective assessments were completed daily by the subjects during the 7-day study period and immediately following the study period.
Prior to the 7-day testing period, application of 10 mmHg negative pressure reduced mean IOP from 18.2 ± 3.8 mmHg to 14.0 ± 2.1 mmHg (p<0.01), a 22% reduction. After 7 days of consecutive nightly wear, repeat IOP measurements with the application of negative pressure showed a decrease in mean IOP from 16.9 ± 4.3 mmHg to 13.5 ± 3.7 mmHg. The observed IOP reduction was in addition to the subjects' current treatment regimen. There were no statistically significant changes in IOP, BCVA from baseline following the 7-day period of nightly wear with the application of negative pressure. The patient-reported outcomes were favorable.
The MPD can safely and comfortably be worn overnight. The decrease in IOP of >20% in addition to current therapy is both clinically and statistically significant. The MPD shows promise as a potential new treatment option for nocturnal IOP control.
Introduction
Prospective, open-label, non-randomized, single site study to assess the safety and tolerability of a multi-pressure dial.
Methods
30 healthy subjects received application of negative ...pressure (–15 mmHg) in one eye for 30 minutes and ambient atmospheric pressure in the contralateral eye. To evaluate safety, the primary outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP) changes from baseline, slit-lamp and dilated fundus examination findings, and rate of adverse events. Exploratory analyses included in this study also evaluated changes from baseline measurement in tear break-up time (TBUT) and RNFL thickness measured by OCT. In addition to baseline screening, subjects underwent testing and negative pressure application on day 0 and returned 1 week after the initial visit for clinical testing. The follow-up visit did not include use of the multi-pressure dial (MPD) but repeated baseline testing and evaluated for adverse events.
Results
No adverse events were reported in the study. After short-term wear of the MPD on day 0, there was a minimal but statistically significant increase of half a line (LogMAR) in BCDVA for study eyes; this increase was not present at 1 week. There were no observed changes in cup-disk ratio and TBUT 1 week after the initial testing. There was a statistically significant pressure reduction in both study and fellow eyes at 1 week following the study, but clinical significance has yet to be determined.
Conclusion
The MPD, which consists of a pair of goggles connected to a handheld, programmable pump, was well tolerated by subjects enrolled in the study. Key safety parameters remained stable after short-term exposure. The favorable safety results of this study support the safety profile of the MPD and promote further investigation of the device as a potential treatment of glaucoma.
Funding
Equinox Ophthalmic, Inc. (Newport Beach, CA).
The purpose of this study was to report a retrospective case series of anterior scleral and limbal inflammatory necrosis after adjuvant miltefosine for recalcitrant Acanthamoeba keratitis (AK).
A ...case series and literature review.
Four eyes of 3 patients with recalcitrant AK developed anterior scleral and limbal inflammatory necrosis with significant scleral-limbal thinning after treatment with miltefosine. The average age was 38 years, and the average duration of infection before miltefosine treatment was 239 days. All cases required urgent surgical intervention to either prevent or mitigate corneal-limbal perforation.
Miltefosine has been observed to result in the resolution of AK when used as an adjunctive therapy. It may also lead to a consecutive inflammatory necrosis of the anterior sclera and limbus. This inflammatory response may be significant enough to cause rapid scleral-limbal thinning with subsequent perforation.
PURPOSE:To evaluate the safety and efficacy of a trabecular microbypass stent combined with cataract surgery in patients with severe open-angle glaucoma.
PATIENTS:The series included 59 eyes with ...severe primary open-angle glaucoma and severe visual field loss as defined by American Academy of Ophthalmology preferred practice pattern criteria.
MATERIALS AND METHODS:Retrospective case series. Patients were implanted with 1 trabecular microbypass stent with concomitant cataract surgery. Primary outcome measures were intraocular pressure (IOP) and number of glaucoma medications. Safety measures included postoperative IOP pressure spikes ≥15 mm Hg or IOP<6 mm Hg at any time point, and the need for additional surgery.
RESULTS:The mean preoperative IOP was 19.25±6.97 mm Hg. Postoperatively, the mean IOP was 14.38±3.63 mm Hg (P<0.01) at 12 months and 14.92±3.86 mm Hg (P<0.01) at 24 months. The mean number of glaucoma medications was 2.27±1.06 preoperatively and 1.63±1.17 (P<0.01) at 24 months postoperative, indicating a 28% reduction in medication use. In total, 4 (7%) eyes required additional surgery. In total, 5 eyes (8%) experienced IOP spikes ≥15 mm Hg, 14 (24%) eyes had IOP spikes ≥10 mm Hg. Overall 55% of eyes had a 20% IOP reduction after 24 months of surgery. Eyes with baseline IOP≤19 had a mean reduction of 2.24 mm Hg 36 months after surgery.
CONCLUSIONS:Trabecular microbypass stent implantation during cataract surgery safely and effectively lowers IOP and medication use in patients with severe primary open-angle glaucoma.
To evaluate the long-term safety and efficacy of a trabecular microbypass stent as a sole procedure in pseudophakic eyes with open-angle glaucoma.
Private practice; Sioux Falls, South Dakota, USA.
...Retrospective, consecutive case series.
The series included pseudophakic eyes of patients with mild to severe open-angle glaucoma (OAG) implanted with 1 trabecular microbypass stent. Data was collected at baseline before the surgery and at 1 day, 1 week, 1 month, and up to 48 months postoperatively. The data included intraocular pressure (IOP), number of glaucoma medications, and whether there was a requirement for secondary surgery.
The study comprised 40 patients (51 eyes). The mean IOP was reduced from 20.33 mm Hg ± 4.83 (SD) at baseline to 15.65 ± 3.45 mm Hg at 48 months postoperatively, indicating a 23% reduction (P < .01). The mean number of glaucoma medications was 2.08 ± 1.06 preoperatively and 1.46 ± 1.07 at 48 months postoperatively (P > .05). Postoperatively, 3 eyes (6%) had IOP spikes of 15 mm Hg or higher than the preoperative value, which responded to topical therapy. Ten eyes (20%) required secondary glaucoma surgery. There were no postoperative or intraoperative complications. Patients who had previous ocular hypotensive medication use and an IOP of 18 mm Hg or higher achieved a statistically significant reduction in both IOP and medication use.
The insertion of a single trabecular microbypass stent effectively provided a sustained reduction in IOP in pseudophakic patients with mild to severe OAG. The IOP reduction was more robust in eyes that had a higher baseline IOP.
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