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.

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.

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.

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.

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.

Evaluating the safety and efficacy of epi-off corneal cross-linking in patients with thin corneas due to keratectasia.

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.

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.

Defocus Curve of Emerging Presbyopic Patients.

Purpose: To create a defocus curve of emerging presbyopic patients of various age groups. Setting: Single site private practice in Sioux Falls, South Dakota. Design: This was a non-randomized, prospective study. All subjects were enrolled from healthy volunteers. Methods: 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. Results: 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). Conclusion: 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.

Clinical Outcomes of a Non-Diffractive Extended Depth-of-Focus IOL in Eyes with Mild Glaucoma.

Purpose: To evaluate the clinical outcomes of a non-diffractive, wavefront-shaping extended depth-of-focus (EDOF) intraocular lens (IOL) in eyes with mild open-angle glaucoma (OAG). Setting: Private practice; Sioux Falls, South Dakota. Design: Prospective, open-label, interventional study. Methods: In total, 52 eyes of 26 patients with mild OAG were enrolled and completed the study. All patients were bilaterally implanted with a non-diffractive, wavefront-shaping EDOF IOL. Seventy-seven percent of the patients were implanted with a trabecular microbypass stent at the time of surgery. Primary outcome measures included binocular corrected and uncorrected distance visual acuity (CDVA and UDVA), uncorrected intermediate and near visual acuity (UIVA and UNVA) and contrast sensitivity as measured by a Pelli-Robson chart. A subjective questionnaire was also administered to patients. Results: At 4 months postoperative, the mean binocular UDVA and CDVA was 0.03 ± 0.12 and -0.06 ± 0.07, respectively. The mean UIVA and UNVA were 0.18 ± 0.12 and 0.31 ± 0.18, respectively. Eighty-five percent of the subjects achieved ≥20/25 UDVA and 77% of the subjects achieved ≥20/32 UIVA at 4 months postoperative. The mean binocular mesopic contrast sensitivity was 1.76 ± 0.16 at a spatial frequency of 1 cycle-per-degree (cpd). Eighty-five percent of the subjects reported they would choose the same lens and 1 subject reported they would choose a different IOL if it meant reduced spectacle independence. Conclusion: The non-diffractive, wavefront-shaping EDOF IOL can be safely implanted in eyes with mild, pre-perimetric open-angle glaucoma with favorable uncorrected distance and intermediate visual acuity. The contrast sensitivity measurements were favorable and the subjective questionnaire revealed satisfactory spectacle independence and patient satisfaction.

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.

Surgical outcomes of excisional goniotomy using the kahook dual blade in severe and refractory glaucoma: 12-month results.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Short-Term Efficacy of Combined ab Interno Canaloplasty and Trabeculotomy in Pseudophakic Eyes with Open-Angle Glaucoma.

Purpose: To evaluate short-term outcomes of combined ab interno canaloplasty and trabeculotomy in pseudophakic eyes with open-angle glaucoma. Patients and Methods: Series included all pseudophakic eyes with open-angle glaucoma treated with up to 360° ab interno canaloplasty and up to 360° ab interno trabeculotomy using a purpose-engineered device (OMNI, Sight Sciences Inc). Data collected prior to surgery and out to 6-months postoperative. Surgical success defined as a 20% reduction in intraocular pressure (IOP) without increase in glaucoma medication, or discontinuation of at least one glaucoma medication without increase in IOP. Other primary endpoints included mean IOP and number of glaucoma medications. Results: The study included 67 eyes of 52 patients with a mean age of 76.5 ± 8.9 years. Preoperative mean IOP was 22.1±8.0 mmHg on 2.3±1.4 glaucoma medications. Pressure lowering effects were sustained out to 6 months postoperative with a mean IOP of 15.2±4.9 mmHg (p < 0.001) and mean medication reduction of 0.7±1.4 (p < 0.001). Surgical success rate was 69.8% (30 eyes) and correlated with preoperative IOP. Two patients required a secondary surgical intervention. Conclusion: Combined ab interno canaloplasty and trabeculotomy as a standalone procedure is an effective means of reducing IOP and medication burden in pseudophakic eyes with open-angle glaucoma.

Association between axial length and toric intraocular lens rotation according to an online toric back-calculator.

AIM: 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. METHODS: Retrospective analysis of data collected online via 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. RESULTS: 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 (P<0.0001) with a parameter estimate of 1.19 (standard error: 0.159) and R 2 of 0.0083. CONCLUSION: 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.

Safety and effectiveness of a new ophthalmic viscosurgical device: randomized, controlled study.

PURPOSE: To evaluate the safety and effectiveness of a new dispersive ophthalmic viscosurgical device (OVD) (ClearVisc) compared with an approved dispersive OVD (Viscoat) when used in cataract surgery. SETTING: 16 clinics in the United States. DESIGN: Prospective multicenter controlled randomized 1:1 (ClearVisc:Viscoat; stratified by site, age group, and cataract severity). Patients and examiners masked. METHODS: Patients aged 45 years or older with age-related noncomplicated cataract considered amenable to treatment with standard phacoemulsification cataract extraction and intraocular lens (IOL) implantation were included. Patients were randomized to receive either ClearVisc or Viscoat using standard techniques. 5 postoperative visits occurred at 6 hours, 24 hours, 7 days, 1 month, and 3 months. The primary effectiveness outcome was the change in endothelial cell density (ECD) from baseline to 3 months. The primary safety end point was the proportion of patients who experienced at least 1 intraocular pressure (IOP) measurement ≥30 mm Hg at any follow-up visit. Noninferiority was tested. Inflammation and adverse events were evaluated. RESULTS: 372 patients were randomized: 184 patients in the ClearVisc group and 188 patients in the Viscoat group. ClearVisc was noninferior to Viscoat in mean percentage of ECD loss from baseline to 3 months (8.4% and 6.8%, respectively). ClearVisc was significantly noninferior to Viscoat in the proportion of patients with postoperative IOP ≥30 mm Hg at any follow-up visit (17.4% and 20.3%, respectively, P = .0002). CONCLUSIONS: ClearVisc dispersive OVD provides surgeons with a new option in the continuum of approved dispersive OVDs with beneficial properties as a surgical aid in cataract extraction and IOL implantation.

The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial.

PURPOSE: To determine patient preference and treatment outcomes with an intracanalicular dexamethasone 0.4 mg insert compared to a standard steroid drop regimen in the contralateral eye following bilateral photorefractive keratectomy (PRK). METHODS: In this randomized, prospective, self-controlled, open-label interventional study, one eye received the dexamethasone insert and the second eye received prednisolone acetate 1% taper following bilateral PRK surgery. Postoperative evaluations were performed on day 3, day 4, month 1, and month 3. Phone call surveys were performed on week 2. The Comparison of Ophthalmic Medications for Tolerability questionnaire was used to determine patient preference between postoperative regimens and postoperative pain. Corneal endpoints included time to epithelialization, presence of corneal haze, sodium fluorescein staining, and modified Standardized Patient Evaluation of Eye Dryness (SPEED) scores. Both corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA) were assessed. RESULTS: Twenty patients participated in the study. At month 3, 70% of patients preferred the dexamethasone insert, 20% preferred prednisolone acetate, and 10% expressed no preference. Patient surveys did not show a difference in postoperative pain between the study group and control group. No statistical difference was shown in time to epithelialization, 90-day CDVA or UDVA, postoperative corneal haze, corneal staining, or modified SPEED scores. CONCLUSIONS: In patients undergoing PRK, there was preference toward a dexamethasone insert in place of topical prednisolone acetate for the postoperative steroid treatment. There were no statistically or clinically significant differences between the two cohorts in regard to healing time or visual outcomes. [J Refract Surg. 2021;37(9):590-594.].

The corneal endothelium: clinical review of endothelial cell health and function.

The endothelial cell is a critical structure within the cornea and is responsible for maintaining corneal clarity through its pump function. Endothelial cells are lost over time naturally but can be injured medically, surgically, or as a part of various dystrophies. Monitoring of endothelial cells can be performed clinically or more formally with specular microscopy. In cases of significant compromise, endothelial cells can be transplanted by various endothelial keratoplasty techniques. The future pipeline is bright for possible endothelial cell regeneration and rehabilitation. This article reviews these topics in depth to provide a comprehensive look at the structure and function of the endothelial cell, etiologies of endothelial cell damage, detailed review of iatrogenic causes of endothelial cell loss, and management strategies.

Descemet Membrane Endothelial Keratoplasty and light adjustable lens triple procedure.

PURPOSE: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS AND IMPORTANCE: 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.

The Effects of Glaucoma and Glaucoma Therapies on Corneal Endothelial Cell Density.

A healthy corneal endothelium is required for corneal clarity. Both the glaucoma disease state and its various forms of treatment can have adverse effects on the corneal endothelium. Both the presence of glaucoma and the magnitude of intraocular pressure elevation are related to endothelial cell loss (ECL). Topical medical therapy, laser procedures, and both traditional surgeries-trabeculectomy and tube-shunts-and newer minimally invasive glaucoma surgeries have variable effects on ECL. This review will summarize the reported effects of glaucoma and its treatment on ECL. Concerns for corneal endothelial cell health should be part of the decision-making process when planning glaucoma therapy for lowering intraocular pressure, with added caution in case of planned device implantation in eyes with preexisting ECL and low endothelial cell density at high risk for corneal endothelial decompensation.

Corneal cross-linking versus conventional management for keratoconus: a lifetime economic model.

AIMS: To assess the cost-effectiveness of corneal collagen cross-linking (CXL) versus no CXL for keratoconus in the United States (US). METHODS: A discrete-event microsimulation was developed to assess the cost-effectiveness of corneal cross-linking (CXL, Photrexa + KXL combination product) versus no CXL for patients with keratoconus. The lifetime model was conducted from a US payor perspective. The source for CXL efficacy and safety data was a 12-month randomized, open-label, sham-controlled, multi-center, pivotal trial comparing CXL versus no CXL. Other inputs were sourced from the literature. The primary outcome was the incremental cost per quality-adjusted life year gained. Costs (2019 USD) and effects were discounted 3% annually. The impacts of underlying uncertainty were evaluated by scenario, univariate, and probabilistic analyses. RESULTS: Starting at a mean baseline age of 31 years and considering a mixed population consisting of 80% slow-progressors and 20% fast-progressors, the CXL group was 25.9% less likely to undergo penetrating keratoplasty (PK) and spent 27.9 fewer years in advanced disease stages. CXL was dominant with lower total direct medical costs (-$8,677; $30,994 versus $39,671) and more QALYs (1.88; 21.80 versus 19.93) compared to no CXL. Considering the impact of reduced productivity loss in an exploratory scenario, CXL was associated with a lifetime cost-savings of $43,759 per patient. CXL was cost-effective within 2 years and cost-saving within 4.5 years. LIMITATIONS: Limitations include those that are common to similar pharmacoeconomic models that rely on disparate sources for inputs and extrapolation on short-term outcomes to a long-term analytical horizon. CONCLUSIONS: Keratoconus is a progressive and life-altering disease with substantial clinical, economic, and humanistic consequences. The economic value of cross-linking is maximized when applied earlier in the disease process and/or younger age, and extends to improved work productivity, out-of-pocket costs, and quality of life.