Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation.

Purpose: To assess the efficiency and safety of an intracanalicular dexamethasone insert (Dextenza, Ocular Therapeutix, Inc) supplemented with a reduced-frequency topical drop regimen in mitigating pain and inflammation post-penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), and Descemet membrane endothelial keratoplasty (DMEK), compared to standard topical corticosteroid therapy. Patients and Methods: Eyes were categorized within the DSEK, DMEK, or PKP groups based on ocular characteristics and surgical indications. Randomized in a 1:1 ratio, the intervention group received Dextenza alongside a lowered drop frequency, while the control group followed a conventional drop protocol with no Dextenza. Primary outcomes included average pain scores and absence of anterior chamber cell and flare. Secondary outcomes included delayed re-epithelialization, corneal rejection episodes, instances of intraocular pressure (IOP) elevation >10mmHg above baseline, cystoid macular edema (CME) occurrence, and the necessity for steroid rescue. Results: The study included 30 eyes (10 PKP, 10 DSEK, 10 DMEK). Mean pain scores (0-100 scale; (0-39 = mild pain, 40-69 = moderate pain, 70-100 = severe pain) in the Dextenza group were 3.6 (PKP), 12 (DSEK), 8 (DMEK), compared to 1.2 (PKP), 0 (DSEK), and 4 (DMEK) in controls. PKP control (n=5): 1 delayed re-epithelialization, 1 IOP elevation, 2 CME. DSEK control (n=5): 1 corneal rejection, 1 IOP elevation, 1 CME. DMEK control (n=5): 1 IOP elevation, 1 CME. DMEK Dextenza (n=5): 1 delayed re-epithelialization, 1 CME. No cases required steroid rescue, and no cell or flare was observed one-week post-surgery. There were no statistically significant differences in pain, delayed re-epithelialization, IOP elevation, corneal rejection, or CME between the Dextenza and control groups regardless of the type of corneal transplantation performed. Conclusion: Dextenza, when combined with a lower-frequency drop regimen, demonstrates a safety profile comparable to that of a traditional higher-frequency drop protocol in terms of pain management and the adverse events explored in this study, potentially enhancing postoperative drop adherence.

Bilaterally subluxed diffractive intraocular lenses: big expectations and even bigger comorbidities.

A 78-year-old woman with an ocular history of cataract surgery with a diffractive intraocular lens (IOL) in each eye has developed fluctuating vision, greater in the right eye than the left eye, after 4 years. She has a history of inactive central serous retinopathy and a vision potential of 20/25 + 2 in the right eye and 20/25 in the left eye. She has well-controlled diabetes, hypertension, and hypercholesterolemia. She has enjoyed her spectacle independence for some time and wishes to have her vision restored. On examination, her uncorrected distance visual acuity (UDVA) was 20/50 in the right eye and 20/25 in the left eye and her uncorrected near visual acuity (UNVA) was J3 in the right eye and J1 in the left eye. Intraocular pressures (IOPs) measured 22 mm Hg in the right eye and 18 mm Hg in the left eye. Pupils had limited reactivity with irregularity in the right eye but no obvious relative afferent pupillary defect. Motility and confrontation visual fields were unremarkable in both eyes. Retinal acuity meter was 20/20 in both eyes, and manifest refraction was plano -1.25 × 105 20/40, J3 in the right eye and +0.50 × 20/25, J1 in the left eye. Pertinent findings on slitlamp examination included temporal iris atrophy and transillumination defects greater in the right eye than the left eye, peripupillary pseudoexfoliative changes in both eyes, significant inferior subluxation of a diffractive 3-piece posterior chamber IOL in the capsular bag with lens-pitting peripherally and few central, moderate pseudophacodonesis, and an open posterior capsule in the right eye. In the left eye, she had mild inferior subluxation of a single-piece acrylic diffractive IOL in the capsular bag with moderate pseudophacodonesis and an open posterior capsule (Figure 1JOURNAL/jcrs/04.03/02158034-202403000-00019/figure1/v/2024-02-20T193212Z/r/image-tiff). All other anterior segment findings were unremarkable. On dilated posterior examination, she had a cup-to-disc ratio of 0.50 in the right eye and 0.65 in the left eye without edema hemorrhage or pallor. There were attenuated vessels in both eyes, posterior vitreous detachment in both eyes, and a few small drusen peripherally in both eyes. There was retinal pigment epithelium irregularity and dropout parafoveal in the right eye and subfoveal in the left eye (Figure 2). There was no evidence of macular edema, subretinal fluid, choroidal thickening, or neovascular membranes. The periphery was unremarkable in both eyes.JOURNAL/jcrs/04.03/02158034-202403000-00019/figure2/v/2024-02-20T193212Z/r/image-tiff What testing would you obtain preoperatively to help guide your decision-making? How would you counsel the patient regarding comorbid conditions and expectations?

Efficacy and Safety of CSF-1 (0.4% Pilocarpine Hydrochloride) in Presbyopia: Pooled Results of the NEAR Phase 3 Randomized, Clinical Trials.

PURPOSE: This study was undertaken to evaluate the safety and efficacy of CSF-1 (0.4% pilocarpine hydrochloride ophthalmic solution) for use in individuals with presbyopia. METHODS: Two Phase 3 multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trials were conducted in 35 private ophthalmology clinics in the United States from October 2020 to February 2022. Key inclusion criteria were the following: (1) age 45-64 years, (2) distance-corrected near visual acuity (DCNVA) at 40 cm ≥0.40 and ≤0.90 logarithm of the minimum angle of resolution (logMAR, approximately 20/50-20/160 Snellen) in at least 1 eye, (3) manifest refraction (MR) between -4.50 and +2.00 diopter (D) sphere in each eye with ≤2.00D difference between eyes, (4) <2.00D of cylinder MR in each eye, (5) ≤0.04 logMAR (20/20-2 or better) corrected distance visual acuity (CDVA) at 4 m in each eye. Key exclusion criteria were the following: (1) >0.14 logMAR (7 letters) improvement in post-vehicle treatment in monocular DCNVA in either eye at visit 1, (2) introcular pressure (IOP) <9 or >22 mm Hg, (3) average dark-adapted pupillometry <3.5 mm in either eye, (4) prior refractive surgery or intraocular lens (IOL) implantation. Participants applied CSF-1 or vehicle twice per day for 2 weeks. Efficacy and safety assessments were performed at several times on days 1, 8, and 15. Response was defined as ≥3-line gain in DCNVA without loss of ≥1-line in CDVA in the study eye under mesopic room lighting conditions. The primary efficacy endpoint was measured 1 hour post-dose 1 on day 8. Key secondary endpoints were 2 hours post-dose 1, and 1 and 2 hours post-dose 2, also on day 8. Safety endpoints were ocular and non-ocular treatment-related adverse events (TRAE), conjunctival redness, drop comfort, slit-lamp biomicroscopy, intraocular pressure, indirect fundoscopy, and CDVA at 4 m. FINDINGS: Six hundred thirteen participants were randomized to CSF-1 (n = 309) or vehicle (n = 304). Participants were predominantly White (80.8%) and female (62.0%), with mean age (standard deviation) of 54.7 (4.8). CSF-1 met the primary and key secondary endpoints. At the primary endpoint, 40.1% of the CSF-1 group achieved response versus 19.1% of the vehicle group (P < 0.0001). The percentage of responders was significantly greater in CSF-1 compared with vehicle at all tested times. Changes from baseline in all safety endpoints were comparable between groups. Most adverse events (AEs) were mild and transient. Neither serious nor severe AEs were reported with CSF-1. IMPLICATIONS: CSF-1, a low-dose pilocarpine ophthalmic solution, demonstrated superiority to vehicle in improving near vision in individuals with presbyopia without compromising distance vision. CSF-1 demonstrated a favorable safety profile. CLINICALTRIALS: gov identifier: NCT04599933 (NEAR-1), NCT04599972 (NEAR-2).

Surgical outcomes of intraocular lens iris suture fixation in eyes with residual capsule support.

PURPOSE: To evaluate the safety and refractive outcomes of eyes after intraocular lens (IOL) iris suture fixation (ISF). SETTING: Private practice, Los Angeles, California. DESIGN: Nonrandomized and unmasked retrospective chart review. METHODS: Eyes that underwent IOL exchange or repositioning with ISF with at least 270 degrees of capsular support were included. Eyes with less than 270 degrees of capsular support and eyes with iris damage were excluded. The primary outcome measures included incidence of cystoid macular edema (CME), IOL dislocation requiring refixation, and chronic inflammation. Secondary outcome measures included worsening intraocular pressure (IOP) control, retinal tear or detachment, worsening of corrected distance visual acuity (CDVA), and corneal decompensation. Refractive outcomes for 26 subgrouped eyes included mean and median spherical equivalent refraction accuracy (SERA), and percentage of eyes within 0.5 diopter (D) and 1 D of the refractive target. RESULTS: The study included 53 eyes of 50 patients. CME: 2/53 (3.8%), IOL dislocation requiring refixation: 2/53 (3.8%), chronic inflammation: 1/53 (1.9%), worsening IOP control: 5/53 (9.4%), retinal tear or detachment: 2/53 (3.8%). No patient experienced worsening of CDVA from baseline or corneal decompensation. Mean SERA ± SD -0.35 ± 0.29 D, median SERA -0.37 D. Of the 26 eyes subgrouped for refractive analysis, 73% were within 0.5 D and 100% were within 1 D of the desired refractive outcome. CONCLUSIONS: ISF can offer stability for sulcus-fixated IOLs provided there is some residual capsule support. Although there are measurable complications, there is a relatively low side effect profile. The refractive error tended to be myopic, indicating the need for further refinement of IOL power predictive formulas.

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?

Comparison of Keratoconus Specific to Standard IOL Formulas in Patients With Keratoconus Undergoing Cataract Surgery.

PURPOSE: To assess the performance of multiple intraocular lens (IOL) formulas in eyes with keratoconus. METHODS: Eyes with stable keratoconus scheduled for cataract surgery with biometry measurements on the Lenstar LS900 (Haag-Streit) were included. Prediction errors were calculated using 11 different formulas, including two with keratoconus modifiers. Primary outcomes compared standard deviations, mean and median numerical errors, and percentage of eyes within diopter (D) ranges across all eyes with subgroup analysis according to anterior keratometric values. RESULTS: Sixty-eight eyes from 44 patients were identified. In eyes with keratometric values less than 50.00 D, prediction error standard deviations ranged from 0.680 to 0.857 D. Percentages of eyes within ±0.50 D of target ranged from 57.89% to 73.68% with no statistical differences among formulas. In eyes with a keratometric value of more than 50.00 D, prediction error standard deviations ranged from 1.849 to 2.349 D and were not statistically different with heteroscedastic analysis; percentages of eyes within ±0.50 D of target ranged from 0% to 18.18% with no statistical differences among formulas. Only keratoconus-specific formulas (Barrett-KC and Kane-KC) and the Wang-Koch axial length adjustment version of SRK/T resulted in median numerical errors not significantly different than 0, regardless of keratometric values. CONCLUSIONS: In keratoconic eyes, IOL formulas are less accurate than in normal eyes and result in hyperopic refractive outcomes that increase with steeper keratometric values. Using keratoconus-specific formulas and the Wang-Koch axial length adjustment version of SRK/T for axial lengths of 25.2 mm or greater improved IOL power prediction accuracy compared to other formulas. [J Refract Surg. 2023;39(4):242-248.].

Clinical outcomes and complications following intraocular lens exchange in the setting of an open or intact posterior capsule.

PURPOSE: To assess whether there are added risks when performing intraocular lens (IOL) exchange in the setting of an open posterior capsule (OPC) when compared with a closed posterior capsule (CPC) IOL exchange. SETTING: Private practice, Los Angeles, California. DESIGN: Nonrandomized and unmasked retrospective chart review. METHODS: Eyes undergoing IOL exchange solely to relieve optical symptoms, with open or intact posterior capsules, were included. Eyes undergoing IOL exchange due to IOL malposition or dislocation were excluded. Eyes with preexisting, uncontrolled glaucoma and inflammation and eyes with a visual potential worse than 20/40 (Snellen) were also excluded. The main outcome measures were the postoperative complications compared between the OPC and CPC groups. RESULTS: 90 eyes of 75 patients undergoing IOL exchange were included in this study; 38/90 eyes had an OPC, and 52/90 eyes had a CPC. 3/38 in the OPC group and 2/52 in the CPC group experienced worsening intraocular pressure control. 1/38 in the OPC group experienced chronic inflammation. 2/38 in the OPC group and 2/52 in the CPC group experienced cystoid macular edema. 1/52 in the CPC group experienced a retinal tear. Statistically or clinically significant differences in postoperative complications between the OPC and CPC groups were not found. CONCLUSIONS: In the hands of an experienced surgeon, IOL exchange with an OPC appear red to be just as safe as IOL exchange with a CPC; when deemed necessary, experienced surgeons may perform an IOL exchange safely in the presence of an OPC.

Approach to a spontaneously ruptured posterior polar cataract.

A 61-year-old man presented with gradual blurring of vision and glare in both eyes for a couple of years, with worsening of the vision in his right eye over the past 2 months. He had no medical history of note. On clinical examination, his visual acuities were 20/80 in the right eye and 20/30 in the left eye, uncorrected. The cornea was clear, and the anterior chamber (AC) was deep in both eyes. He had bilateral mild nuclear sclerosis with round central onion-ring-like posterior opacities. The opacities measured approximately 2 mm in diameter and were marginally larger in the right eye than in the left eye (Figure 1JOURNAL/jcrs/04.03/02158034-202305000-00018/figure1/v/2023-04-20T184543Z/r/image-tiff). In addition, there were 2 curvilinear lines across the right posterior capsule (PC), one of which passed across the lens opacity (Figure 2JOURNAL/jcrs/04.03/02158034-202305000-00018/figure2/v/2023-04-20T184543Z/r/image-tiff). Fundus examination was normal in both eyes, and the vitreous was clear. Optical coherence tomography (OCT) of the macular and optic nerve in both eyes was normal. The endothelial cell count in both eyes exceeded 2000 cells/mm2. He had been told by a previous ophthalmologist to have bilateral cataracts and was now keen for surgery starting with the right eye. He works as a manager in a large company and is an avid golf player. He is emmetropic and wears spectacles for near work. Optical biometry using predicated posterior corneal astigmatism did not recommend a toric intraocular lens (IOL). He had done his internet research on IOL options and requested trifocal IOLs. What is your surgical plan for right cataract removal? Explain which IOL you would choose to implant.

Surgical decisions in the setting of zonulopathy.

An 85-year-old man with a history of type 2 diabetes, pseudoexfoliation (PXF) in both eyes, and tamsulosin use was referred for the evaluation of a dense cataract in the right eye and a subluxated intraocular lens (IOL) in the left eye. Unfortunately, his surgery in the left eye was complicated by diffuse zonulopathy. The referring surgeon placed a 3-piece IOL in the sulcus. However, the passively fixated 3-piece IOL moved inferiorly causing monocular diplopia for over a year. Because the patient was pleased with the IOL immediately postoperatively, a refixation procedure was performed in the form of sulcus placement with iris suture fixation in the left eye. Fortunately, the iris-fixated IOL in the left eye has remained well centered and stable without cystoid macular edema (CME) or chronic inflammation for over 8 months. The patient is on no ocular medications and has no family history of glaucoma. He now needs cataract surgery in the right eye and is extremely apprehensive because of his difficult course in the left eye. The corrected distance visual acuity is 20/70 in the right eye and 20/25 in the left eye. Intraocular pressures (IOPs) measure 20 mm Hg in the right eye and 14 mm Hg in the left eye by Goldmann tonometry. Pachymetry is 536 µm in the right eye and 543 µm in the left eye. Pupils are round with minimal reactivity and without a relative afferent pupillary defect. Extraocular motility is normal in both eyes, and confrontation visual fields is full in both eyes. Gonioscopy reveals an angle open to the pigmented trabecular meshwork (PTM) in the right eye and the ciliary body in the left eye with 1+ PTM and without peripheral anterior synechia in both eyes. The retinal nerve fiber layer and macular optical coherence tomography are normal in both eyes. On slitlamp examination, pertinent findings include pseudoexfoliative changes at the pupillary margin with poor dilation of 3.5 mm in both eyes; the anterior chamber (AC) is shallow but adequate in the right eye and deep and quiet with rare pigmented cells in the left eye. There is a 5+ nuclear sclerotic cataract with pseudoexfoliative changes on the anterior capsule and no obvious phacodonesis in the right eye and a 3-piece posterior chamber IOL in the sulcus fixated to the iris with 10-0 polypropylene sutures at 6 and 12 o'clock without pseudophacodonesis in the left eye. Dilated fundus examination reveals a cup-to-disc ratio of 0.4 with healthy neuroretinal rims in both eyes, posterior vitreous detachments in both eyes, and no evidence of diabetic retinopathy in both eyes. All other findings are unremarkable. How would you counsel this patient regarding his risk factors for surgery in the right eye? What surgical maneuvers would you use to remove the cataract safely? How would you stabilize the IOL if the capsule bag becomes compromised due to zonulopathy?

Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery.

Purpose: To evaluate the effectiveness and safety of a sustained-release intracanalicular dexamethasone insert (Dextenza, Ocular Therapeutix, Inc.) as an adjunctive therapy in patients undergoing cataract and corneal surgery. Patients and Methods: This retrospective case series contains 18 patients undergoing cataract surgery and 6 patients undergoing corneal surgery. All patients received the Dextenza intracanalicular insert. 6/18 of the patients in the cataract surgery arm were on the standard of care post-surgery topical steroid drop regimen, whereas 11/18 of the patients were on a reduced regimen. 1/18 of the patients was on a drop regimen that deviated from the aforementioned regimens. 2/6 of the patients in the corneal surgery arm were on the standard of care post-surgery topical steroid drop regimen, whereas 3/6 of the patients were on a reduced regimen. 1/6 of the patients were on a drop regimen that deviated from the aforementioned regimens. Results: The primary outcome measures are intraocular pressure (IOP) levels and anterior chamber inflammation levels across the post-operative recovery period. 1/18 of the patients in the cataract surgery arm and 1/6 of the patients in the corneal surgery arm experienced a clinically significant IOP spike greater than 10 millimeters of mercury (mmHg) above baseline IOP. No patient in either of the study groups had significant inflammation after 1 week post-surgery. 1/18 of the patients in the cataract surgery arm and 1/6 of the patients in the corneal surgery arm experienced a canalicular obstruction. Conclusion: Dextenza with the lower drop protocol showed non-inferiority in terms of inflammation management and safety. As with any steroid delivery mechanism, monitoring IOP is paramount when using Dextenza. One of the patients with a canalicular obstruction had a history of punctal plug implantation, so care should be taken when choosing to implant Dextenza in such a patient.

Anterior segment reconstruction due to cosmetic iris implants placed in the anterior chamber.

A 27-year-old woman had BrightOcular iris implants placed for cosmetic purposes that changed eye color from brown to blue bilaterally. Of note, BrightOcular implants are not approved by the U.S. Food and Drug Administration (FDA) for use in the United States and have been associated with severe ocular complications. In keeping with their design, they were placed in the anterior chamber (AC) in both eyes of this patient; surgery was performed outside the United States. As has been described previously and tragically in other cases, she developed chronic inflammation, intolerable glare, angle-closure glaucoma, corneal edema, and cataracts in both eyes. For medically unmanageable elevated intraocular pressure (IOP), she underwent diode laser cyclophotocoagulation (CPC) in both eyes, and eventually, an Ahmed tube shunt (New World Medical, Inc.) was placed in the right eye. Although she was advised and urged to have the iris implants removed, despite her ocular issues, she refused removal until intolerable glare and reduced vision ensued. Ultimately, both iris implants were extracted 5 years after implantation by a U.S. surgeon; the procedures resulted in corneal decompensation and progressive cataract development. Subsequent penetrating keratoplasty (PKP) was performed for the right eye, but it failed because of contact with the glaucoma tube shunt. She sought additional consultation and presented with the following findings: corrected distance visual acuity was 20/400 in the right eye and 20/40 in the left eye, IOP of 18 mm Hg in the right eye and 16 mm Hg in the left eye, pupils were nonreactive and fixed, and extraocular muscles and central visual field were normal. Pachymetry was 868 µm in the right eye and 653 µm in the left eye. Anterior segment examination in the right eye revealed a failed corneal graft with 3+ edema, peripheral anterior synechiae (PAS) for 360 degrees, shallow AC, Ahmed tube shunt at the 11 o'clock position and remnant iris adherent to the graft-host junction for 270 degrees, 3+ posterior subcapsular cataract, and 2+ cortical cataract (Figure 1JOURNAL/jcrs/04.03/02158034-202208000-00024/figure1/v/2022-08-01T210317Z/r/image-tiff). The sclera revealed multiple circular and circumferential atrophic blue spots consistent with high-energy transscleral CPC (Figure 2JOURNAL/jcrs/04.03/02158034-202208000-00024/figure2/v/2022-08-01T210317Z/r/image-tiff). In the left eye, she had remnant fixed dilated iris for 270 degrees, missing iris superiorly for 3 clock hours, an adequate AC, and 2+ cortical cataract (Figure 3JOURNAL/jcrs/04.03/02158034-202208000-00024/figure3/v/2022-08-01T210317Z/r/image-tiff). Posterior segment examination revealed a 0.5 cup-to-disc ratio in both eyes with normal vessels, macula, vitreous, and retinal periphery, bilaterally. Given this constellation of findings, how would you proceed?

Results of the United States Food and Drug Administration Clinical Trial of the CustomFlex Artificial Iris.

PURPOSE: To evaluate safety and efficacy of a custom-manufactured artificial iris device (CustomFlex Artificial Iris; HumanOptics AG) for the treatment of congenital and acquired iris defects. DESIGN: Multicenter, prospective, unmasked, nonrandomized, interventional clinical trial. PARTICIPANTS: Patients with photophobia, sensitivity secondary to partial or complete congenital or acquired iris defects, or both. METHODS: Eyes were implanted from November 26, 2013, to December 1, 2017, with a custom, foldable artificial iris by 1 of 4 different surgical techniques. Patients were evaluated 1 day, 1 week, and 1, 3, 6, and 12 months after surgery. At each examination, slit-lamp findings, intraocular pressure, implant position, subjective visual symptoms, and complications were recorded. Corrected distance visual acuity (CDVA) and endothelial cell density (ECD) were measured at 3, 6, or 12 months as additional safety evaluations. The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was used to assess health-related quality of life affected by vision. The Global Aesthetic Improvement Scale was used to assess cosmetic results. MAIN OUTCOME MEASURES: Photosensitivity, glare, visual symptoms, NEI VFQ-25 score, Global Aesthetic Improvement Scale rating, prosthesis-related adverse events, intraocular lens (IOL)-related adverse events, and surgery-related adverse events 12 months after surgery. RESULTS: At the 12-month postoperative examination, a 59.7% reduction in marked to severe daytime light sensitivity (P < 0.0001), a 41.5% reduction in marked to severe nighttime light sensitivity (P < 0.0001), a 53.1% reduction in marked to severe daytime glare (P < 0.0001), and a 48.5% reduction in severe nighttime glare (P < 0.0001) were found. A 15.4-point improvement (P < 0.0001) in the NEI VFQ-25 total score was found, and 93.8% of patients reported an improvement in cosmesis as measured by the Global Aesthetic Improvement Scale 12 months after surgery. No loss of CDVA of > 2 lines related to the device was found. Median ECD loss was 5.3% at 6 months after surgery and 7.2% at 12 months after surgery. CONCLUSIONS: The artificial iris surpassed all key safety end points for adverse events related to the device, IOL, or implant surgery and met all key efficacy end points, including decreased light and glare sensitivity, improved health-related quality of life, and satisfaction with cosmesis. The device is safe and effective for the treatment of symptoms and an unacceptable cosmetic appearance created by congenital or acquired iris defects.

A mysterious myopic surprise.

A 73-year-old man with an ocular history of inactive age-related macular degeneration and chronic angle-closure glaucoma (CACG) in both eyes recently underwent femtosecond laser-assisted cataract surgery/phacoemulsification and intraocular lens (IOL) implantation with simultaneous Hydrus microstent (Ivantis, Inc.) implantation in the left eye. Although there was some reported subincisional iris prolapse due to intraoperative floppy iris, the case was otherwise uneventful according to the referring surgeon. Two months postoperatively, he was referred to our office for a myopic surprise of approximately 2.0 diopters (D) in the left eye (Figure 1JOURNAL/jcrs/04.03/02158034-202202000-00022/figure1/v/2022-01-26T192641Z/r/image-tiff). Of note, he has a distant history of acute ACG and complicated cataract surgery in the right eye with a failed trabeculectomy. He subsequently had laser peripheral iridoplasty to pull the iris away from the angle in the right eye (Figure 2JOURNAL/jcrs/04.03/02158034-202202000-00022/figure2/v/2022-01-26T192641Z/r/image-tiff). His topical intraocular pressure (IOP)-lowering medications at presentation included dorzolamide-timolol 1 drop twice daily in the left eye and 1 drop of timolol in the right eye once daily. His past medical history is significant for hypertension and benign prostatic hyperplasia, and his oral medications include Tamsulosin (Flomax), Irbasartan (Avapro), and Atenolol. On examination, he had an UCDVA of 20/20 in the right eye and 20/80 in the left eye, and a BCDVA of 20/20 in the right eye and 20/25 in the left eye. His manifest refraction was plano in the right eye and 1.50 -0.75 × 90 in the left eye. IOP measured 19 mm Hg in the right eye and 26 mm Hg in the left eye. Pupil examination revealed a nonreactive pupil in the right eye and a round sluggish pupil in the left eye without an obvious relative afferent pupillary defect. Extraocular motility and confrontational visual fields were full in both eyes. On slitlamp examination, pertinent findings included the following: 1+ corneal guttata without edema in both eyes; anterior chambers were shallow but adequate in both eyes with scattered peripheral anterior synechiae in the right eye and a uniformly shallow but adequate chamber in the left eye; there was no cell or flare in either eye. Iris findings included a surgical pupil with a fibrotic pupillary membrane, laser iridoplasty scars with scattered temporal transillumination defects (TIDs) in the right eye, and 2.5 clock hours of TIDs and a patent peripheral iridotomy at 1 o'clock in the left eye; lens examination revealed centered posterior chamber IOLs with open posterior capsules in both eyes and lens pitting in the left eye. Pertinent findings on dilated fundus examination included a cup-to-disc ratio of 0.3 in both eyes with good neuroretinal rims and macular examination revealed medium-sized drusen with pigment clumping in both eyes and no active choroidal neovascular membranes. The remainder of the examination was unremarkable. What is the etiology of this myopic surprise? What diagnostic testing will help confirm the diagnosis and what are the best management options for this patient?

Diffractive optic intraocular lens exchange: indications and outcomes.

PURPOSE: To assess indications and outcomes of surgical exchange of diffractive optic multifocal and extended depth-of-focus intraocular lenses (IOLs) in favor of monofocal IOLs. SETTING: Private practice, Los Angeles, California. DESIGN: Retrospective chart review. METHODS: All cases of diffractive optic IOL exchange between June 2007 and October 2020 for diffractive optic dysphotopsia (DOD) (ie, light-induced concentric circles and spider web patterns), poor visual quality, or night vision symptoms were evaluated retrospectively regarding surgical indications, comorbidities, surgical methods, surgical complications, and visual outcomes. Ocular surface disease and ametropia were managed prior to consideration of IOL exchange. RESULTS: The charts of 64 eyes of 46 patients were included. 53/64 (83%) had DOD, 50/64 (78%) experienced reduced quality of vision, and 12/64 (19%) complained of night vision difficulties. 27/64 (42%) of eyes had no ocular comorbidities; 15/64 (23%) of eyes had more than 1 comorbid condition, and 12/64 (19%) were post-laser refractive surgery. Laser posterior capsulotomy had been performed in 15/64 (23%) of eyes. There were a variety of inciting diffractive optic IOLs and various monofocal exchange lenses and fixation techniques were used based on symptoms, comorbidities, and status of the posterior capsule. After IOL exchange, all eyes were relieved of DOD, and all eyes had improved or unchanged corrected distance visual acuity. CONCLUSIONS: Diffractive optic IOLs may induce unsatisfactory visual outcomes. However, in this large series of IOL exchanges, DOD and reduced visual function can be overcome with exchange for a monofocal IOL, despite comorbidities or an open posterior capsule.

Clinical and histopathological findings in the dead bag syndrome.

PURPOSE: To describe the findings of a recently described syndrome, the dead bag syndrome, in which the capsular bag appears to be clear many years postoperatively, becoming diaphanous and floppy and unable to support the intraocular lens (IOL) within it. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah. DESIGN: Case series with clinicopathological correlation. METHODS: Of 10 cases suspected to represent a dead bag syndrome, 8 IOLs and 7 capsular bags were removed because of subluxation or dislocation. The 7 capsular bags available for analysis were fixed in formalin and submitted to histopathological examination (hematoxylin-eosin and Masson trichrome stains). The associated explanted IOLs in 5 cases were also examined microscopically. RESULTS: Histopathologic examination of the 7 capsular bags showed capsular thinning and/or splitting. Lens epithelial cells (LECs) were completely absent on 2 specimens, whereas the other 5 specimens had rare LECs on the inner surface of the capsule. Explanted IOLs were 3-piece silicone IOLs or single-piece hydrophobic acrylic IOLs. 1 IOL optic showed a small amount of granular pigment deposition, but the optics of the other 4 IOLs were unremarkable. CONCLUSIONS: In this syndrome, there seems to be an absence of secondary proliferation of LECs and fibrotic changes. The capsule shows some signs of degradation, such as thinning and/or splitting. Weakness of zonular attachments seems to be an associated finding, with subsequent in-the-bag IOL dislocation. Further studies are necessary to ascertain the etiology of this condition.

Persistent negative dysphotopsia and small eyes August consultation #1.

A 56-year-old man with an ocular history of strabismus surgery at age 3 years, anatomically narrow angles, and patent laser peripheral iridotomies in both eyes underwent refractive lens exchange in which a SA60AT (Alcon Laboratories, Inc.) 38 diopter (D) intraocular lens (IOL) was implanted in the right eye and a SA60AT 36 D IOL was implanted in the left eye. He presented with symptoms consistent with negative dysphotopsia (ND) in both eyes immediately after surgery, describing temporal dark arcs that were constantly present and did not improve over the past 2 years. Of note, the patient was most symptomatic in the left eye. On examination, the manifest refractions and corrected distance visual acuities were -0.50 +1.50 × 20 and 20/20 in the right eye and +0.75 -1.25 × 158 and 20/20 in the left eye; visual fields, extraocular motility, and pupils were normal. Intraocular pressures were normal as measured by applanation tonometry at 10 mm Hg in both eyes. Slitlamp examination revealed trace meibomian gland disease in both eyes, normal tear lake and cornea, and patent peripheral laser iridotomies at the 11 o'clock position in the right eye and the 1 o'clock position in the left eye. The anterior chamber was slightly shallow temporally but deep centrally and quiet in both eyes. The lens examination revealed 4.0 mm anterior fibrotic capsule openings with well-positioned SA60AT posterior chamber IOLs in the bag with haptics at 1 and 7 o'clock in both eyes (Figure 1JOURNAL/jcrs/04.03/02158034-202108000-00021/figure1/v/2021-07-22T111213Z/r/image-tiff). The posterior capsule was intact with trace posterior capsule opacification in both eyes and striae in the posterior capsules. Dilated fundus examination was unremarkable with a cup-to-disc ratio of 0.4 in the right eye and 0.3 in the left eye and normal pink neuroretinal rims. What strategies would you offer this patient to treat the ND and what specific testing and counseling do you provide for patients with this condition?

Femtosecond laser-assisted intraocular lens exchange.

Intraocular lens (IOL) exchange in patients with anterior capsule contraction resulting from phimosis can complicate IOL exchange as the fibrotic anterior capsule must be cut to gain access to the IOL. Maintaining curvilinear capsulotomy is particularly important when the desired outcome is bag-to-bag IOL exchange. Similarly, when the posterior capsule is open, properly sized curvilinear anterior capsulotomy will allow for optic capture and further stability of the exchanged IOL. Secondary capsulotomy size ranged from 4.9 to 5.0 mm, and the energy was set at 4 to 10 µJ depending on diffusiveness of the anterior capsule. The femtosecond laser was adapted to create a secondary anterior capsulotomy to facilitate IOL exchange.