Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension.

PURPOSE: To evaluate the safety and intraocular pressure (IOP)-lowering efficacy of 2 models of the travoprost intraocular implant (fast-eluting [FE] and slow-eluting [SE] types) from 1 of 2 phase 3 trials (the GC-010 trial). DESIGN: Multicenter, randomized, double-masked, sham-controlled, noninferiority trial. PARTICIPANTS: Patients with open-angle glaucoma or ocular hypertension having an unmedicated baseline mean diurnal IOP (average of 8 am, 10 am, and 4 pm time points) of ≥ 21 mmHg, and IOP of ≤ 36 mmHg at each of the 8 am, 10 am, and 4 pm timepoints at baseline. METHODS: Study eyes were randomized to the travoprost intraocular implant (FE implant [n = 200] or SE implant [n = 197] model) or to timolol ophthalmic solution 0.5% twice daily (n = 193). MAIN OUTCOME MEASURES: The primary outcome was mean change from baseline IOP in the study eye at 8 am and 10 am, at each of day 10, week 6, and month 3. Safety outcomes included adverse events (AEs) and ophthalmic assessments. RESULTS: Mean IOP reduction from baseline over the 6 time points ranged from 6.6 to 8.4 mmHg for the FE implant group, from 6.6 to 8.5 mmHg for the SE implant group, and from 6.5 to 7.7 mmHg for the timolol group. The primary efficacy end point was met; the upper limit of the 95% confidence interval of the difference between the implant groups and the timolol group was < 1 mmHg at all 6 time points. Study eye AEs, most of mild or moderate severity, were reported in 21.5%, 27.2%, and 10.8% of patients in the FE implant, SE implant, and timolol groups, respectively. The most common AEs included iritis (FE implant, 0.5%; SE implant, 5.1%), ocular hyperemia (FE implant, 3.0%; SE implant, 2.6%), reduced visual acuity (FE implant, 1.0%; SE implant, 4.1%; timolol, 0.5%), and IOP increased (FE implant, 3.5%; SE implant, 2.6%; timolol, 2.1%). One serious study eye AE occurred (endophthalmitis). CONCLUSIONS: The travoprost intraocular implant demonstrated robust IOP reduction over the 3-month primary efficacy evaluation period after a single administration. The IOP-lowering efficacy in both implant groups was statistically and clinically noninferior to that in the timolol group, with a favorable safety profile. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

The effects of negative periocular pressure on intraocular pressure.

Glaucoma is a major cause of blindness, and IOP reduction remains the only clinically-validated therapy. In this study, we analyze a novel IOP-lowering strategy that uses a modest negative pressure (vacuum) applied locally to the periorbital region by a pair of goggles with each lens individually connected to a programmable pump. Motivated by clinical data showing an IOP reduction, we used an existing validated lumped-parameter model of the eye to understand the putative mechanism of this treatment. The model considers aqueous humor dynamics, episcleral venous pressure, and changes in ocular blood volume to describe how IOP changes with time in response to an external perturbation. We find that clinical data are qualitatively and quantitatively consistent with model predictions if we include two primary mechanisms in the model: first, negative pressure application causes a relatively rapid increase in globe volume accompanied by increased blood volume in the eye. Second, negative pressure application reduces episcleral venous pressure, causing a slower adjustment of IOP due to altered aqueous humor dynamics. These results provide testable hypotheses that hopefully will lead to a fuller experimentally-driven understanding of how negative periocular pressure influences IOP. Evaluating the long-term effects of such treatments on glaucoma patients requires further clinical study.

iStent inject trabecular micro-bypass stents with topical prostaglandin as standalone treatment for open-angle glaucoma: 4-year outcomes.

IMPORTANCE: Long-term data are needed regarding effective and safe glaucoma treatment modalities. BACKGROUND: This study evaluated 4-year outcomes of second-generation trabecular micro-bypass stent implantation (iStent inject) combined with topical travoprost in open-angle glaucoma (OAG). DESIGN: Prospective, non-randomized, multi-surgeon study at a tertiary care ophthalmology centre. PARTICIPANTS: OAG subjects with preoperative intraocular pressure (IOP) 18 to 30 mmHg on two medications and 22 to 38 mmHg post-washout. METHODS: Subjects (n = 53) underwent standalone iStent inject implantation and started travoprost on postoperative Day 1. Measures included IOP, medications, comprehensive ophthalmic examinations and testing, and adverse events (AEs). Annual medication washouts were performed. MAIN OUTCOME MEASURES: Mean medicated and unmedicated IOP; and proportions of eyes with IOP ≤18mmHg, ≤15 mmHg, or ≥20% reduced while on travoprost vs screening IOP on two medications. RESULTS: At 48 months postoperative, 85% of eyes reduced IOP ≥20% on travoprost vs screening IOP on 2 medications; 92% of eyes had IOP ≤18 mmHg on travoprost; and 83% had IOP ≤15 mmHg on travoprost. At Month 49 (post-washout), 90% of eyes reduced IOP ≥20% vs preoperative washout IOP. Throughout follow-up, mean IOP on travoprost was 11.9 to 13.0 mmHg (34%-40% reduced vs 19.7 mmHg on 2 medications preoperatively; P < .0001 throughout), and post-washout IOP was 16.5 to 17.7 mmHg (28%-34% reduced vs 24.9 mmHg preoperatively; P < .0001 throughout). Favourable safety included minimal AEs; stable visual acuity, cup-to-disc ratio and visual fields; and no secondary surgeries. CONCLUSIONS AND RELEVANCE: Combining iStent inject implantation with topical prostaglandin produced significant and safe 4-year IOP and medication reductions in OAG.

Trabecular micro-bypass stent implantation with cataract extraction in pigmentary glaucoma.

IMPORTANCE: Use of the trabecular micro-bypass stent with cataract surgery is well established to be safe and effective in primary open-angle glaucoma. This is the first study to exclusively evaluate use of the device in pigmentary glaucoma. BACKGROUND: This study aimed to investigate the safety and efficacy of a trabecular micro-bypass stent in combination with cataract surgery in pigmentary glaucoma. DESIGN: Retrospective, consecutive case series. PARTICIPANTS: Twenty-four eyes of 12 patients with pigmentary glaucoma implanted with one trabecular micro-bypass stent with concomitant cataract surgery. METHODS: Baseline data was collected and compared to the following postoperative time points: 1 day, 1 week, 1 month out to 36 months (M36) after the procedure. MAIN OUTCOME MEASURES: These included intraocular pressure (IOP), number of glaucoma medications and need for additional surgery. RESULTS: At M36 there was a 25% reduction in IOP to 14.68 ± 3.0 (P < .01) from 19.50 ± 6.7 mmHg at baseline. The mean number of glaucoma medications was 0.75 ± 1.0 prior to the surgery and 0.59 ± 0.6 (P > .05) at 36 M. At the 36 M time-point, 95% of eyes had IOP ≤ 18 mmHg and 68% of eyes were ≤ 15 mmHg. No eyes underwent a secondary glaucoma procedure. CONCLUSIONS AND RELEVANCE: The insertion of a single trabecular micro-bypass stent in combination with cataract surgery effectively provides a sustained reduction in IOP up to 3 years after surgery in patients with pigmentary glaucoma. The safety profile is favourable with low rate of IOP spikes and no patients requiring additional surgery.

The Role of Corneal Hysteresis in Predicting Outcomes in Glaucoma Patients Undergoing Trabecular Microbypass Stent in Combination with Cataract Surgery.

INTRODUCTION: Trabecular microbypass stents are effective at lowering intraocular pressure in patients with mild to moderate glaucoma. Corneal hysteresis has been shown to correlate with reduction in intraocular pressure in patients using topical prostaglandin analogues and selective laser trabeculoplasty to treat glaucoma. The purpose of this study was to investigate whether baseline corneal hysteresis measurements were predictive of effectiveness of trabecular microbypass stents in treating glaucoma. METHODS: This was a retrospective chart review of 163 eyes from 109 patients with primary open angle glaucoma that underwent simultaneous trabecular microbypass stenting and cataract surgery. This was a single center study with one surgeon performing all procedures. RESULTS: The eyes were grouped into quartiles according to baseline corneal hysteresis measurements. Baseline intraocular pressures among the four quartiles of baseline corneal hysteresis groups were similar (p=0.082, ANOVA). The average intraocular pressure reduction at 3 months post-operative visits were 3.67, 1.51, 2.83, and 2.09 mmHg for the first through fourth quartiles respectively, and these differences are insignificant overall (p=0.34, ANOVA). Likewise, no significant difference was detected in terms of reduction in glaucoma medications among the quartiles three months after surgery (p=0.78, ANOVA). CONCLUSION: Baseline corneal hysteresis does not appear to show any value in predicting intraocular pressure reduction in response to placement of a trabecular microbypass stent for treating glaucoma.

Dysfunctional tear syndrome: dry eye disease and associated tear film disorders - new strategies for diagnosis and treatment.

Dysfunctional tear syndrome (DTS) is a common and complex condition affecting the ocular surface. The health and normal functioning of the ocular surface is dependent on a stable and sufficient tear film. Clinician awareness of conditions affecting the ocular surface has increased in recent years because of expanded research and the publication of diagnosis and treatment guidelines pertaining to disorders resulting in DTS, including the Delphi panel treatment recommendations for DTS (2006), the International Dry Eye Workshop (DEWS) (2007), the Meibomian Gland Dysfunction (MGD) Workshop (2011), and the updated Preferred Practice Pattern guidelines from the American Academy of Ophthalmology pertaining to dry eye and blepharitis (2013). Since the publication of the existing guidelines, new diagnostic techniques and treatment options that provide an opportunity for better management of patients have become available. Clinicians are now able to access a wealth of information that can help them obtain a differential diagnosis and treatment approach for patients presenting with DTS. This review provides a practical and directed approach to the diagnosis and treatment of patients with DTS, emphasizing treatment that is tailored to the specific disease subtype as well as the severity of the condition.

Implantation of two second-generation trabecular micro-bypass stents and topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 18-month follow-up.

IMPORTANCE: Additional data are sought regarding treatment options for glaucoma, a major cause of global blindness. BACKGROUND: The study assessed outcomes following standalone implantation of two second-generation trabecular micro-bypass stents and postoperative topical prostaglandin in eyes with open-angle glaucoma not controlled on two preoperative medications. DESIGN: The study design is a prospective, nonrandomized, open-label study at a tertiary-care ophthalmology centre. PARTICIPANTS: Subjects had open-angle glaucoma with preoperative intraocular pressure of 18-30 mmHg on two medications, a medication washout phase, and post-washout intraocular pressure of 22-38 mmHg. All subjects (N = 53) have been followed for 18 months. METHODS: One day following implantation of two second-generation trabecular micro-bypass stents, subjects started topical travoprost. Medication washout was repeated at month 12. MAIN OUTCOME MEASURES: The main outcome measure was the proportion of eyes with intraocular pressure reduction ≥ 20% versus medicated baseline intraocular pressure with reduction of one medication at 12 months. RESULTS: At 12 months, 91% of eyes achieved intraocular pressure reduction ≥ 20% with reduction of one medication. All eyes had intraocular pressure ≤ 18 mmHg with reduction of one medication, and 87% had intraocular pressure ≤ 15 mmHg. Mean intraocular pressure on one medication was ≤ 13.0 mmHg (≥ 34% reduction) through 18 months. Mean post-washout intraocular pressure at month 13 was 33% lower than preoperative unmedicated intraocular pressure. No adverse events occurred through 18 months. CONCLUSIONS AND RELEVANCE: In open-angle glaucoma eyes on two preoperative medications, treatment with two second-generation trabecular stents and one postoperative prostaglandin resulted in mean intraocular pressure ≤ 13 mmHg with reduction of one medication, with favourable safety. These findings show the utility of second-generation trabecular bypass with postoperative prostaglandin in patients with open-angle glaucoma.

Comparison of Manual, Femtosecond Laser, and Precision Pulse Capsulotomy Edge Tear Strength in Paired Human Cadaver Eyes.

PURPOSE: To compare the anterior lens capsulotomy edge tear strength created by manual continuous curvilinear capsulorhexis (CCC), femtosecond laser capsulotomy (FSLC), and a new automated precision pulse capsulotomy (PPC) device. DESIGN: A 3-arm study in paired human cadaver eyes. PARTICIPANTS: A total of 44 eye specimens from 22 donors in the United States. METHODS: Capsulotomy was performed in all eye specimens using manual CCC, a femtosecond laser (LenSx, Alcon, Fort Worth, TX), or an automated PPC device (Zepto, Mynosys Inc., Fremont, CA). The first study arm consisted of 8 pairs of eyes in which 1 eye received PPC and the fellow eye received FSLC. The second study arm consisted of 8 pairs of eyes, with 1 eye receiving PPC and the fellow eye receiving manual CCC. The third study arm consisted of 6 pairs of eyes, with 1 eye receiving a manual CCC and the fellow eye receiving FSLC. After phacoemulsification, 2 capsulotomy edge retractors attached to force transducers were used to stretch the capsulotomy edge of each eye and to measure the resisting force until the capsulotomy edge was torn. MAIN OUTCOME MEASURES: Capsulotomy edge tear strength in millinewtons. RESULTS: The PPC edge tear strength was greater than that of FSLC for all 8 pairs of eyes by an average factor of 3.1-fold (PPC mean 73.3±24.9 mN vs. femtosecond laser mean 26.1±6.8 mN; P = 0.012, Wilcoxon matched-pairs, signed-ranks test). The PPC tear strength was greater than that of manual CCC for all 8 pairs of eyes by an average factor of 4.1-fold (PPC mean 95±35.2 mN vs. manual CCC mean 29.1±23.1 mN; P = 0.012, Wilcoxon matched-pairs signed-ranks test). There was no significant difference in the tear strength of capsulotomies produced by manual CCC (mean 21.3±4.9 mN) and FSLC (mean 24.5±11.4 mN) (P = 0.75, Wilcoxon matched-pairs signed-ranks test). CONCLUSIONS: The strength of the PPC capsulotomy edge was significantly stronger than that produced by femtosecond laser or manual CCC.

The business of refractive laser assisted cataract surgery (ReLACS).

PURPOSE OF REVIEW: Refractive Laser Assisted Cataract Surgery (ReLACS) combines the femtosecond laser with other noncovered tests and services in an attempt to reduce spectacle dependence in combination with cataract surgery. Significant interest is present among ophthalmologists who are considering adopting this technology, however significant capital outlays and continuing expenses can make the decision to adopt ReLACS foreboding. We review the financial considerations of ReLACS and review the trends seen in early adopters of this technology. RECENT FINDINGS: Recent findings have shown that ReLACS is a growing segment of cataract surgery. Most practices who have implemented the technology have broken even and have a positive outlook on the financial return of implementing the ReLACS program. The average break-even analysis point for practices is around 230 cases a year. SUMMARY: ReLACS is growing and appears to be a financial viable approach for many practices.

Anatomical considerations for reducing ocular emergencies during spaceflight.

PURPOSE: The privatization of space travel is opening civilian spaceflight to an unprecedented number of individuals now and in the immediate future. The increase in the number and diversity of space travelers will mean increased exposure to both physiologic and pathologic changes observed during acute and prolonged microgravity. AIMS: In this paper, we describe the anatomic, physiologic, and pharmacologic factors to consider that impact acute angle-closure glaucoma risk during spaceflight. CONCLUSIONS: Based on these factors, we elaborate upon areas of medical considerations and provide future recommendations that may aid in reducing the risk of acute angle-closure glaucoma in the next era of spaceflight.

Sensitivity and specificity of SS-OCT for detecting macular pathologies vs SD-OCT.

PURPOSE: To evaluate the sensitivity and specificity of swept-source optical coherence tomography (SS-OCT) biometer compared with the gold standard spectral-domain optical coherence tomography (SD-OCT) for detecting macular pathology in patients with cataract. SETTING: Eye Centers of Tennessee, Crossville, TN. DESIGN: Prospective, cross-sectional, observational, examiner-masked. METHODS: The study included 132 participants aged 50 years and older, who underwent precataract surgery work-up. All participants underwent fixation check retinal scans using SS-OCT biometer (IOLMaster 700) as well as full macular scans using Cirrus SD-OCT. 3 independent masked examiners evaluated the scans if they were normal or had a suspected pathology. Different measures of diagnostic accuracy were calculated for 3 examiners. RESULTS: True positive rate (sensitivity) ranged from 71.1% (32/45) to 79.2% (42/53), and false negative rate was between 20.8% (11/53) and 28.9% (13/45) for the 3 examiners. True negative rate (specificity) ranged from 86.8% (59/68) to 94.1% (64/68), and false positive rate was between 5.9 (4/68) and 13.2% (9/68). The fitted receiver operating characteristic area ranged from 0.83 to 0.95. CONCLUSIONS: Using retinal SS-OCT biometer scans as a replacement of the dedicated macular SD-OCT for screening or diagnosing macular health would not be appropriate because of its low sensitivity. SS-OCT biometer may potentially fail to identify approximately one-fourth of patients who actually have the disease. Therefore, the final decision on macular health should be based on the gold standard SD-OCT scans. When full macular SD-OCT scans are not accessible, the limited retinal scan information from SS-OCT biometer may still provide useful insights into the macular health.

Clinical outcomes of the light adjustable lens in eyes with a history of prior corneal refractive surgery.

PURPOSE: This study aimed to evaluate the visual and refractive outcomes in eyes with a history of laser corneal refractive surgery implanted with the second-generation light-adjustable lens (LAL). SETTING: Private Practice, Sioux Falls, South Dakota, US. DESIGN: Retrospective, consecutive case series. METHODS: Eyes with a history of prior corneal refractive surgery that underwent cataract surgery with implantation of the LAL and were targeted for plano were included. Data on the type and number of prior refractive surgeries were collected, in addition to the timing and number of postoperative adjustments. The primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and the percentage (%) of eyes within ±0.25 diopter (D), ±0.50D, and ±1.00 D of their refractive target. RESULTS: 76 eyes from 70 patients were included. A total of 45 eyes with a history of one prior refractive surgery and 31 eyes with a history of ≥2 refractive surgeries were included. 74% (n=56) of all eyes achieved UDVA of 20/20 or better, 88% (n=67) achieved 20/25 UDVA or better and 93% (n=71) were correctable to 20/20 or better postoperatively. For refractive outcomes, 66% of eyes (n=50) were within ±0.25 D and 86% (n=65) were within ±0.50 D of refractive target. CONCLUSIONS: Patients with a history of laser corneal refractive surgery achieved favorable visual and refractive outcomes with the LAL. This intraocular lens (IOL), which affords postoperative adjustability, is a promising option for patients with a history of corneal refractive surgery who maintain high expectations for functional uncorrected acuity following cataract surgery.

Efficacy and Safety of the Travoprost Intraocular Implant in Reducing Topical IOP-Lowering Medication Burden in Patients with Open-Angle Glaucoma or Ocular Hypertension.

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.

Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial.

INTRODUCTION: This prospective, multicenter, randomized, double-masked pivotal phase 3 trial evaluated the efficacy and safety of the travoprost intracameral SE-implant (slow-eluting implant, the intended commercial product) and FE-implant (fast-eluting implant, included primarily for masking purposes) compared to twice-daily (BID) timolol ophthalmic solution, 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: The trial enrolled adult patients with OAG or OHT with an unmedicated mean diurnal intraocular pressure (IOP) of ≥ 21 and unmedicated IOP ≤ 36 mmHg at each diurnal timepoint (8 A.M., 10 A.M., and 4 P.M.) at baseline. The eligible eye of each patient was administered an SE-implant, an FE-implant or had a sham administration procedure. Patients who received an implant were provided placebo eye drops to be administered BID and patients who had the sham procedure were provided timolol eye drops to be administered BID. The primary efficacy endpoint, for which the study was powered, was mean change from baseline IOP at 8 A.M. and 10 A.M. at day 10, week 6, and month 3. Non-inferiority was achieved if the upper 95% confidence interval (CI) on the difference in IOP change from baseline (implant minus timolol) was < 1.5 mmHg at all six timepoints and < 1 mmHg at three or more timepoints. The key secondary endpoint was mean change from baseline IOP at 8 A.M. and 10 A.M. at month 12. Non-inferiority at month 12 was achieved if the upper 95% CI was < 1.5 mmHg at both timepoints. Safety outcomes included treatment-emergent adverse events (TEAEs) and ophthalmic assessments. RESULTS: A total of 590 patients were enrolled at 45 sites and randomized to one of three treatment groups: 197 SE-implant (the intended commercial product), 200 FE-implant, and 193 timolol. The SE-implant was non-inferior to timolol eye drops in IOP lowering over the first 3 months, and was also non-inferior to timolol at months 6, 9, and 12. The FE-implant was non-inferior to timolol over the first 3 months, and also at months 6 and 9. Of those patients who were on glaucoma medication at screening, a significantly greater proportion of patients in the SE- and FE-implant groups (83.5% and 78.7%, respectively) compared to the timolol group (23.9%) were on fewer topical glaucoma medications at month 12 compared to screening (P < 0.0001, chi-square test). TEAEs, mostly mild, were reported in the study eyes of 39.5% of patients in the SE-implant group, 34.0% of patients in the FE-implant group and 20.1% of patients in the timolol group. CONCLUSIONS: The SE-travoprost intracameral implant demonstrated non-inferiority to timolol over 12 months whereas the FE-implant demonstrated non-inferiority over 9 months. Both implant models were safe and effective in IOP lowering in patients with OAG or OHT. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03519386.

The Novel Optical Design and Clinical Classification of a Wavefront-Shaping Presbyopia-Correcting Intraocular Lens.

Purpose: To evaluate the clinical rationale of wavefront-shaping technology, describe how intraocular lenses (IOLs) using wavefront-shaping technology are differentiated from refractive or diffractive optical presbyopia-correcting designs, and describe the mode of action of this technology. Methods: Extended depth of focus (EDoF) IOLs are the latest class of presbyopia-correcting IOLs addressing the growing demand of patients for reduced spectacle dependence. These use various optical technologies, including diffractive designs (eg, TECNIS Symfony ZXR00 and AT LARA 29 MP) and non-diffractive designs such as small aperture (eg, IC-8 IOL and XtraFocus Pinhole Implant), spherical aberration (eg, MINI WELL Ready and LuxSmart), and wavefront shaping (eg, AcrySof IQ Vivity DFT015 and Clareon Vivity CNWET0). Despite some improvement in visual acuity at intermediate and near distances, these technologies can still be associated with increased rate of visual disturbances or poorer distance vision compared with monofocal IOLs. One way to overcome such limitations is using a wavefront-shaping optical principle. Results: Clinical data show that wavefront-shaping technology results in a continuous EDoF compared with a monofocal IOL while exhibiting a minimal halo, similar to an aspheric monofocal IOL. Clinically, this translates to a lens that has proven to exceed the American National Standards Institute/American Academy of Ophthalmology criteria for an EDoF IOL. Conclusion: The novel wavefront-shaping optic technology allows patients to achieve a continuous range of vision from distance to functional near with low levels of visual disturbances comparable with aspheric monofocal IOLs.

Alternatives to Topical Glaucoma Medication for Glaucoma Management.

Topical glaucoma medications have favorable safety and efficacy, but their use is limited by factors such as side effects, nonadherence, costs, ocular surface disease, intraocular pressure fluctuations, diminished quality of life, and the inherent difficulty of penetrating the corneal surface. Although traditionally these limitations have been accepted as an inevitable part of glaucoma treatment, a rapidly-evolving arena of minimally invasive surgical and laser interventions has initiated the beginnings of a reevaluation of the glaucoma treatment paradigm. This reevaluation encompasses an overall shift away from the reactive, topical-medication-first default and a shift toward earlier intervention with laser or surgical therapies such as selective laser trabeculoplasty, sustained-release drug delivery, and micro-invasive glaucoma surgery. Aside from favorable safety, these interventions may have clinically important attributes such as consistent IOP control, cost-effectiveness, independence from patient adherence, prevention of disease progression, and improved quality of life.

The Effects of Negative Periocular Pressure on Biomechanics of the Optic Nerve Head and Cornea: A Computational Modeling Study.

Purpose: The purpose of this study was to evaluate the effects of negative periocular pressure (NPP), and concomitant intraocular pressure (IOP) lowering, on the biomechanics of the optic nerve head (ONH) and cornea. Methods: We developed a validated finite element (FE) model of the eye to compute tissue biomechanical strains induced in response to NPP delivered using the Multi-Pressure Dial (MPD) system. The model was informed by clinical measurements of IOP lowering and was based on published tissue properties. We also conducted sensitivity analyses by changing pressure loads and tissue properties. Results: Application of -7.9 mmHg NPP decreased strain magnitudes in the ONH by c. 50% whereas increasing corneal strain magnitudes by c. 25%. Comparatively, a similar increase in corneal strain was predicted to occur due to an increase in IOP of 4 mmHg. Sensitivity studies indicated that NPP lowers strain in the ONH by reducing IOP and that these effects persisted over a range of tissue stiffnesses and spatial distributions of NPP. Conclusions: NPP is predicted to considerably decrease ONH strain magnitudes. It also increases corneal strain but to an extent expected to be clinically insignificant. Thus, using NPP to lower IOP and hence decrease ONH mechanical strain is likely biomechanically beneficial for patients with glaucoma. Translational Relevance: This study provides the first description of how NPP affects ONH biomechanics and explains the underlying mechanism of ONH strain reduction. It complements current empirical knowledge about the MPD system and guides future studies of NPP as a treatment for glaucoma.

Precisional modulation of translaminar pressure gradients for ophthalmic diseases.

The translaminar pressure gradient (TLPG) refers to two forces at the lamina cribosa of the optic nerve: the anteriorly acting intracranial pressure (ICP), and posteriorly-acting intraocular pressure (IOP). It has been proposed that controlling the translaminar pressure gradient at regular intervals may preserve the optic nerve and slow the course of glaucoma. The precisional modulation of this TLPG is a recently introduced concept that may play a role in the treatment of ophthalmic diseases such as glaucoma. In this manuscript, we review the applications of pressurized goggles on ophthalmic diseases. We also elaborate upon current investigations in modulation of the TLPG including goggles and the multi-pressure dial goggle. We discuss future research directions for ophthalmic diseases including spaceflight associated neuro-ocular syndrome (SANS), a large physiological barrier to future long-duration spaceflight.

Outcomes of LASIK vs PRK enhancement in eyes with prior cataract surgery.

PURPOSE: To compare postenhancement visual acuity between patients who underwent postcataract laser in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK). SETTING: A private, tertiary referral practice in Sioux Falls, South Dakota. DESIGN: 3-year, retrospective chart review. METHODS: Patients who underwent postcataract extraction excimer laser enhancement surgery targeted for emmetropia (±0.50 diopter). Postenhancement uncorrected distance visual acuity (UDVA) and manifest refraction spherical equivalent (MRSE) was recorded for all available follow-ups and compared for both groups. RESULTS: 822 postcataract enhanced eyes (491 LASIK; 331 PRK). For patients with at least 6-month follow-up, mean UDVA was 0.05 ± 0.13 logMAR in LASIK-enhanced patients and 0.15 ± 0.20 in PRK-enhanced patients ( P < .001). Mean absolute value MRSE was 0.22 ± 0.36 and 0.48 ± 0.62 for LASIK-enhanced and PRK-enhanced patients at or beyond 6 months, respectively ( P < .001). 330 (67%) LASIK-enhanced patients achieved 20/20 or better postenhancement UDVA, compared with 142 (43%) PRK-enhanced patients ( P < .001). Controlling for pre-enhancement UDVA, LASIK-enhanced patients showed significantly better postenhancement UDVA than PRK-enhanced patients, except in those with pre-enhancement vision of 20/20 or better, or those worse than 20/50. LASIK-enhanced virgin corneas had mean postenhancement of 0.05 ± 0.14 UDVA compared with 0.13 ± 0.19 UDVA in PRK-enhanced virgin cornea patients ( P < .001). CONCLUSIONS: LASIK provides better and more predictable outcomes in UDVA than PRK in postcataract enhancement patients, even when controlling for pre-enhancement visual acuity and prior ocular procedures.