The Effectiveness and Safety of a Novel Crosslinked Hyaluronate Canalicular Gel Occlusive Device for Dry Eye.

PURPOSE: Evaluate effectiveness and safety of a crosslinked hyaluronate (HA) canalicular filler (Lacrifill Canalicular Gel) compared to a commercially available hydrogel canalicular plug (Form Fit). SETTING: 5 sites in United States. DESIGN: Prospective, multicenter, controlled, double-masked, randomized 2:1 (filler:plug). METHODS: Adults (≥22 years) with Schirmer test (with anesthesia) ≤10 mm/5 minutes, presence of corneal staining, ocular surface disease index (OSDI) of ≥23 with ≤3 responses of "not applicable," patent lacrimal drainage system, and bilateral best-corrected distance visual acuity of 20/40 or better. Filler or plugs were instilled bilaterally in the inferior canaliculi. Primary effectiveness endpoint was non-inferiority of the mean within subject change from baseline to Month 3 in Schirmer score for patients receiving filler compared to plugs. The key secondary effectiveness endpoint was non-inferiority of the proportion of patients with filler achieving improvement from baseline to Month 3 in OSDI by a minimal clinically important difference (MCID). Additional endpoints included the mean change from baseline to 3 and 6 months in tear meniscus height, OSDI, corneal staining, tear break-up time, and safety. RESULTS: 157 patients were randomized; 99 patients with crosslinked HA filler and 52 patients with hydrogel plugs completed the study. Filler was non-inferior to plugs in the mean Schirmer score change from baseline and in the proportion of patients achieving a clinically important improvement in OSDI. CONCLUSIONS: Crosslinked HA filler is a safe, well-tolerated, and effective method to treat dry eye. Clinically and statistically significant improvements in signs and symptoms of dry eye were sustained through 6 months.

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.

Implantable Collamer Lens Procedure Planning: A Review of Global Approaches.

More than 2 million implantable collamer lenses (ICLs) have been implanted worldwide. With a central port to improve aqueous flow through the ICL, the latest iteration of this phakic intraocular lens (pIOL) has been shown to have stable outcomes with very low rates of adverse events. However, correct planning and ICL size selection continue to be important to achieve an optimal vault. Shallow or excessive vaults are not complications in and of themselves but may increase the risk of complications. Historically, surgeons have relied on measurements of anterior chamber depth (ACD) and manual, caliper-measured white-to-white (WTW) distance to select the ICL size. New diagnostic and imaging technologies such as optical coherence tomography (OCT) and ultrasound biomicroscopy (UBM) provide additional opportunities for visualization and measurement of the intraocular dimensions involved in phakic intraocular lens implantation, including sulcus-to-sulcus (STS) and angle-to-angle (ATA) diameters. This paper reviews various approaches to ICL planning and sizing that have been published in the peer-reviewed literature, all of which produce acceptable results for predicting vault and size selection. Surgeons may also want to identify a methodology for patient evaluation and ICL size selection that best aligns with their personal preferences, diagnostic technology, and familiarity with analytical optimization tools.

Phakic intraocular lenses (pIOLs) are one method for correcting nearsightedness, with or without astigmatism. This category of refractive surgery has been growing rapidly in the US and around the world. Implantation of the implantable collamer lens (ICL), one type of pIOL, is safe and effective, with stable outcomes and low adverse event rates. When complications do occur, they are typically associated with an inappropriate vault, or distance between the implant and the natural lens. Preoperative planning and accurate ICL sizing are required to achieve an optimal vault and varies, depending on the diagnostic technology available to the surgeon. This paper reviews the current approaches to ICL planning and sizing in order to provide guidance to surgeons implanting this pIOL.

Radial keratotomy and cataract surgery: A quest for emmetropia.

A 75-year-old man with an ocular history of 8-cut radial keratotomy (RK) in both eyes presented for cataract surgery evaluation. He was previously correctable in spectacles in years prior despite his irregular corneas to 20/25 in the right eye and 20/30 in the left eye. He recently noticed a change in his overall visual function with significant nighttime glare and difficulty reading despite spectacle correction. Of note, he was unable to tolerate contact lenses and was resistant to refitting despite additional encouragement. Cataract surgery was delayed for many years, given he was correctable in spectacles and the concern of uncovering a highly aberrated cornea after removing his cataracts (Figures 1 and 2JOURNAL/jcrs/04.03/02158034-202308000-00021/figure1/v/2023-07-21T030437Z/r/image-tiffJOURNAL/jcrs/04.03/02158034-202308000-00021/figure2/v/2023-07-21T030437Z/r/image-tiff). Of note, the patient was interested in returning to the spectacle independence he enjoyed in the past. Ocular examination revealed a corrected distance visual acuity (CDVA) of 20/30 in the right eye and 20/60 in the left eye, with a manifest refraction of +4.50 -0.50 × 177 in the right eye and +5.75 -1.75 × 14 in the left eye. Glare testing was 20/50 in the right eye and 20/100 in the left eye, with retinal acuity meter testing of 20/25 in each eye. Pupils, confrontation visual fields, and intraocular pressures were normal. Pertinent slitlamp examination revealed corneal findings of 8-cut RK with nasal-gaping arcuate incisions in both eyes and lens findings of 2+ nuclear sclerosis with 2+ cortical changes in the right eye and 3+ nuclear sclerosis with 3+ cortical changes in the left eye. Cup-to-disc ratios of the optic nerves measured 0.5 with temporal sloping in the right eye and 0.6 with temporal sloping in the left eye. The dilated fundus examination was unremarkable. What intraocular lens (IOL) options would you offer this patient and how would you counsel regarding realistic expectations? What additional diagnostic testing would be helpful in your assessment? How would you calculate the IOLs?

Clinical performance of a hybrid presbyopia-correcting intraocular lens in patients undergoing cataract surgery in a multicenter trial.

PURPOSE: To compare the clinical performance of TECNIS Synergy intraocular lens (IOL), model ZFR00V, vs TECNIS IOL, model ZCB00, in cataract patients. SETTING: Multicenter clinical setting. DESIGN: Prospective, randomized, subject/evaluator-masked clinical trial. METHODS: Cataract patients aged ≥22 years were randomly assigned 1:1 to bilateral implantation with ZFR00V or ZCB00. Key end points at 6 months postsurgery included monocular and binocular visual acuities at 4 m, 66 cm, 33 cm, and/or 40 cm, binocular distance-corrected defocus testing, patient-reported outcomes, and safety. RESULTS: 272 patients were implanted with ZFR00V (135) or ZCB00 (137). At 6 months, 83/131 (63.4%) ZFR00V patients demonstrated 20/25 or better combined monocular distance-corrected vision at far, intermediate, or near, compared with 5/130 (3.8%) ZCB00 patients. ZFR00V demonstrated excellent binocular uncorrected vision at intermediate (0.022 logMAR) and distance-corrected vision at 40 cm (0.047 logMAR). Strong ZFR00V performance persisted under mesopic conditions (0.244 logMAR or ∼20/32 Snellen), where improvement over ZCB00 with distance-corrected vision at near was 3.5 lines. ZFR00V provided a broad range of functional vision (20/32 or better) through -3.5 diopters of defocus (29 cm). Most ZFR00V patients reported no spectacle wear overall (93.1%) or at all 4 viewing distances combined (87.8%), and 55.7% qualified as completely spectacle independent. Relatively low proportions of ZFR00V patients reported being very/extremely bothered by halos (13.7%), starbursts (11.5%), or night glare (8.4%). The safety profile was similar between IOL groups. CONCLUSIONS: TECNIS Synergy ZFR00V demonstrated improved intermediate and near vision, increased range of vision, and greater spectacle independence vs TECNIS monofocal ZCB00.

Clinical Evaluation of a Modified Light Transmission Short-Wavelength Filtering Intraocular Lens Compared to a Colorless Control.

INTRODUCTION: The aim of this study was to evaluate the safety and efficacy of a violet-light filtering intraocular lens (IOL) compared to a colorless IOL control. METHODS: This was a prospective, bilateral, randomized, comparative, patient/evaluator-masked multi-center clinical trial at 12 sites in the USA. Patients underwent standard small-incision phacoemulsification cataract extraction. Visual acuity, contrast sensitivity, and color vision were tested 12 months postoperatively. Patient satisfaction and vision-related quality of life were evaluated based on directed patient responses obtained from a binocular subjective questionnaire. RESULTS: A total of 250 subjects were bilaterally implanted with the violet-light filtering TECNIS monofocal ZV9003 (n = 126) and colorless TECNIS monofocal ZA9003 (n = 124). Mean uncorrected distance visual acuity (UDVA) was 0.123 LogMAR for ZV9003 and 0.116 LogMAR for the ZA9003 group. Mean corrected distance visual acuity (CDVA) was 0.00 LogMAR for both groups. No significant difference was found between the groups for 22/25 questionnaire categories, including color perception. A significant difference was found in favor of the ZV9003 group for day driving, night driving, and frustration with vision. Contrast sensitivity mean difference was < 0.05 log units across all lighting conditions and spatial frequencies. CONCLUSION: No difference was found between groups for visual acuity, contrast sensitivity, color testing, and adverse events as well as with the majority of optical/visual symptoms. A statistical difference was noted in driving and frustration with eyesight that may be related to benefits of using a violet-light filtering chromophore. Overall, the violet-light filtering ZV9003 showed excellent visual acuity and contrast sensitivity results with a low incidence of optical/visual symptoms.

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.

Topical Ocular TRPV1 Antagonist SAF312 (Libvatrep) for Postoperative Pain After Photorefractive Keratectomy.

Purpose: Evaluation of safety and efficacy of topical ocular SAF312 (Libvatrep) in post-photorefractive keratectomy (PRK) pain. Methods: In this placebo (vehicle)-controlled, participant- and investigator-masked study, 40 participants were randomized (1:1) to two treatment sequences in a bilateral PRK crossover design (SAF312 2.5% followed by vehicle [or vice versa], one eye drop, four times daily for 72 hours after PRK). Primary endpoints were visual analog scale (VAS) pain scores at 6 hours after first drop of study drug and average VAS scores over 0 to 12 hours postoperatively. Secondary endpoints included postoperative oral rescue medication (ORM) use and adverse events (AEs). Results: All 40 participants completed the study. Both primary endpoints were met; mean difference in VAS pain scores between SAF312- and vehicle-treated eyes was -11.13 (P = 0.005, -25%) at 6 hours postoperatively and -8.56 (P = 0.017, -22%) over 0 to 12 hours. Mean VAS pain scores with SAF312 were consistently lower than with vehicle from 1 hour postoperatively up to 30 hours (P ≤ 0.10 observed in 8/11 time points). Less ORM was taken with SAF312 up to 0 to 72 hours postoperatively, with a trend of fewer participants taking ORM at 0 to 24 hours postoperatively with SAF312 versus vehicle. No serious AEs were reported. All ocular AEs were mild and transient, and none were drug related. SAF312-treated eyes showed no delay in wound healing and had a lower grade 4 conjunctival hyperemia 24 hours postoperatively versus vehicle-treated eyes. Conclusions: SAF312 was well tolerated and effective in reducing ocular pain post-PRK. Translational Relevance: Topical SAF312 presents a new therapeutic option for patients undergoing PRK.

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.

A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease.

Purpose: To compare TearCare and Lipiflow systems in the ability to reduce the symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). Methods: In this multicenter, masked, randomized-controlled trial, 235 subjects received a single TearCare treatment (n = 115) or a single LipiFlow treatment (n = 120) and were followed for 1-month post-treatment. DED symptoms were assessed using the Ocular Surface Disease Index (OSDI), Symptom Assessment in Dry Eye (SANDE), and Eye Dryness (ED) questionnaires at baseline and at 1 month. Post-hoc subgroup analysis was conducted on subjects with less severe and more severe gland obstruction determined by baseline meibomian gland secretion score (MGSS). Results: TearCare system significantly improved total OSDI, SANDE, and ED scores from baseline (p < 0.0001) at 1-month follow-up. Subjects with more severe disease (MGSS <7) achieved statistically greater reduction with TearCare compared to LipiFlow in total OSDI score (30.4 ± 2.53 and 21.9 ± 2.37, respectively, p ANCOVA = 0.0160), OSDI Section B score for quality of vision (5.1 ± 0.48 and 3.6 ± 0.45, respectively, p ANCOVA= 0.0206), and SANDE frequency score (51.9 ± 3.70 and 41.5 ± 3.45, respectively, p ANCOVA = 0.0455). Conclusion: TearCare provides significant DED symptom relief at 1 month after a single treatment. Outcomes were consistent in OSDI, SANDE, and ED assessments. In subjects with more severe gland dysfunction, TearCare performed significantly better than LipiFlow in improving quality of vision and overall DED symptom frequency determined by OSDI and SANDE. Clinical Trial Registration Number: NCT03857919.

In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study.

Purpose: To evaluate the clinical outcomes with optometrist pre-surgical insertion of dexamethasone ophthalmic insert 0.4mg in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy. Methods: In this prospective, contralateral eye trial, one eye received a dexamethasone ophthalmic insert 0.4mg and the other received topical prednisolone acetate 1% four times per day for one week, then three times per day for one week, then two times per day for one week, and then one time per day for one week. At one day, seven days, and four weeks postoperatively mean anterior chamber cell score and mean anterior chamber flare score was assessed by Slit Lamp Biomicroscopy and pain score was assessed by Visual Analog Scale from 0-10. Incidence of increased intraocular pressure and cystoid macular edema were also assessed. Results: Thirty patients (60 eyes) participated. At one day postoperative there was no significant difference in mean anterior chamber cell score (p= 0.70) or pain score (p= 0.92). There was no anterior chamber cell flare observed in the study or control group. Of the 30 patients, 29 expressed a preference for dexamethasone inserts compared to topical prednisolone acetate. One patient in the study group had elevated intraocular pressure that resolved and there was no cystoid macular edema measured. Conclusion: In patients undergoing routine cataract surgery, there was an overwhelming preference for a dexamethasone insert compared to topical steroid drops. The dexamethasone insert produced similar ocular comfort and inflammation prevention compared to prednisolone acetate eyedrops. Dexamethasone inserts are a safe and effective treatment option for reducing pain and inflammation when inserted by an optometrist prior to routine cataract surgery.

Diagnosis and management of postrefractive surgery ectasia.

Postrefractive surgery ectasia is a serious, sight-threatening complication seen after the following procedures: laser in situ keratomileusis, photorefractive keratectomy, small-incision lenticule extraction, radial keratotomy, and/or arcuate keratotomy. Specific risk factors may include age, corneal thickness, degree of refractive error, corneal topographic changes including irregular astigmatism, percent tissue ablation, and residual stromal bed. Biomarkers may be a new option to help indicate who is at greatest risk for ectasia. Visual aids including spectacles or contacts lenses are often required to achieve optimal vision. Collagen crosslinking is the only treatment believed to stop progression of ectasia and prevent keratoplasty. Other surgical options may include topography-guided phototherapeutic keratectomy and intrastromal corneal ring segments. Ultimately, an "ounce of prevention is a pound of cure," so careful preoperative screening and ultimately offering the safest and most effective treatments for patients is arguably the most important job of the refractive surgeon.

Use of P1-P4 Purkinje reflections as a surrogate sign for intraoperative patient fixation.

Circumferential, even anterior capsular overlap maximizes intraocular lens stability and posterior capsular opacification mitigation and provides best long-term outcomes for the cataract patient. P1 and P4 Purkinje reflections at patient fixation may provide a reliable marker for capsulotomy centration. However, patient fixation may be hindered during surgery because of anesthesia or light sensitivity. In this study, we demonstrate that the relationship between the P1 and P4 Purkinje reflections previewed prior to surgery when the patient is fixating may be recreated intraoperatively if fixation becomes difficult. The final position of P1 and P4 relative to one another at fixation is invariant in a given patient, but there are variations among patients. Knowledge of the P1 and P4 relationship can be used as a surrogate sign of patient fixation to assist in capsulotomy centration during cataract surgery.

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.].

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.

Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens.

PURPOSE: To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon). DESIGN: Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial. PARTICIPANTS: Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision. METHODS: Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria. MAIN OUTCOME MEASURES: The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances. RESULTS: Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was <0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P < 0.001) and DCIVA (difference of 0.26 logMAR; P < 0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6. CONCLUSIONS: The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery.

Overnight Safety Evaluation of a Multi-Pressure Dial in Eyes with Glaucoma: Prospective, Open-Label, Randomized Study.

PURPOSE: To investigate the safety and tolerability of the multi-pressure dial (MPD) worn overnight for seven consecutive days. DESIGN: Prospective, open-label, randomized, single-site study. SUBJECTS: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study.

Purpose: To compare, in a masked manner, a novel cross-linked hyaluronic acid ocular bandage gel (OBG) versus standard-of-care bandage contact lens (BCL) plus artificial tears with respect to safety and effectiveness in healing epithelial defects created for photorefractive keratectomy (PRK). Methods: This was a randomized, reading center-masked, exploratory study. Forty-five patients (myopic without significant anisometropia) scheduled for bilateral PRK (9-mm epithelial defect) were randomized post-PRK to treatment with OBG 8 times daily for 3 days, followed by 4 times daily for 11 days (Group 1); OBG 4 times daily for 14 days (Group 2); or BCL and artificial tears (Control). A masked reading center used image analysis of digital slit lamp photos of the fluorescein-stained cornea to evaluate defect size during the 14-day postoperative follow-up period. Effectiveness endpoints were (1) time to complete closure of the corneal defect and (2) proportion of patients with complete healing on day 3 postoperatively, whose defect remained closed. Safety assessments included findings for adverse events and vision, Standard Patient Evaluation of Eye Dryness (SPEED™) Questionnaire, slit lamp, intraocular pressure, and fundus examinations. Results: The proportion of patients with complete healing at 3 days was 73.3%, 86.7%, and 66.7% of patients in Groups 1, 2, and Control, respectively. On day 2, the mean wound size was 6%-26% smaller in Groups 1 and 2 compared with Control. No safety concern arose. SPEED scores were not significantly different across groups. Conclusion: OBG offers a well-tolerated and effective therapy for quickly reepithelializing the cornea following trauma, disease, or surgery.

Comparison of a new sublingual sedation troche with midazolam, ketamine, and ondansetron with intravenous sedation and the effects on vital signs.

PURPOSE: To compare effects of the MKO Melt (midazolam 3 mg, ketamine 25 mg, and ondansetron 2 mg) with intravenous (IV) sedation on vital signs of patients who underwent cataract surgery. SETTING: Two private ophthalmology practices in Sioux Falls, South Dakota, USA. DESIGN: Retrospective analysis. METHODS: Preoperative, intraoperative, and postoperative vital signs were compared between individuals who underwent cataract surgery and received exclusively either MKO (n = 991) or traditional IV methods (n = 120) for sedation. Clinical significance was defined as a 5 mm Hg change in blood pressure, 3 beats per minute (bpm) change in heart rate, a change of 2 respirations per minute, or a change of 3% in O2 saturation. MKO Melt but not IV sedation was given before the reported preoperative vital signs. RESULTS: There were 1111 patients included in this study. Preoperative systolic blood pressure (SBP) was 133.7 ± 15.6 mm Hg in the MKO group and 139.6 ± 17.3 mm Hg in the IV group (P = .0001). Postoperative SBP was 130.8 ± 12.9 mm Hg in the MKO group and 135.8 ± 19.3 mm Hg in the IV group (P < .01). Postoperative heart rate was 66.3 ± 10.4 bpm in the MKO group compared with 69.8 ± 10.5 bpm in the IV group (P < .001). No other clinically and statistically significant differences were found. The mean number of melts used was 1.5. CONCLUSIONS: Clinically and statistically significant improvements in preoperative and postoperative SBP and postoperative heart rate were observed in patients who received MKO Melt. The MKO Melt was safe, effective, and well tolerated and a viable alternative to IV sedation.

Optimization of Oxygen Dynamics, UV-A Delivery, and Drug Formulation for Accelerated Epi-On Corneal Crosslinking.

Purpose: Corneal collagen crosslinking (CXL) through an intact epithelium (epi-on) at high irradiance could potentially improve patient comfort, visual recovery, and clinical workflow compared to conventional epi-off CXL. However, intact epithelium limits stromal delivery of the oxygen, photosensitizer, and ultraviolet-A (UV-A) radiation needed to drive CXL. This ex vivo study evaluated three different epi-on CXL protocols compared to positive and negative controls, specifically focusing on the impact of supplemental oxygen. Endpoints included stromal oxygen levels, stiffness of crosslinked tissue, and acute flattening of whole eyes.Materials & Methods: Ex vivo porcine eyes were held in a custom environmental chamber. Intrastromal oxygen levels were continuously measured before, during, and after UV illumination by a fiberoptic probe inserted into a laser-cut flap. Accelerated, high irradiance, epi-on CXL protocols using riboflavin formulated with benzalkonium chloride (BAC) were studied, with and without supplemental oxygen. These were compared to an alternate, low irradiance, epi-on protocol using riboflavin formulated with sodium iodide. Both negative (no CXL) and positive (epi-off modified Dresden protocol) controls were performed. Post-CXL elastic modulus was measured using extensiometry and anterior tangential curvature was measured using a Scheimpflug tomographer.Results: Protocols including supplemental oxygen resulted in an approximately 5-fold increase in stromal oxygen levels prior to CXL. During epi-on, high-irradiance UV-A delivery under hyperoxic conditions, an aerobic state was maintained. Conversely, under normoxic conditions, stromal oxygen rapidly depleted to 0-5% for all other protocols. The combination of supplemental oxygen, BAC formulation, and high-irradiance UV-A resulted in the largest biomechanical changes and most pronounced flattening effects of the three epi-on protocols.Conclusions: Ex vivo analysis of stromal oxygen levels, corneal stiffness, and acute anterior curvature change indicates that simultaneous optimization of the oxygen environment, riboflavin formulation, and UV-A protocol can significantly increase the effects of corneal collagen crosslinking.