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.

n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease.

BACKGROUND: Dry eye disease is a common chronic condition that is characterized by ocular discomfort and visual disturbances that decrease quality of life. Many clinicians recommend the use of supplements of n-3 fatty acids (often called omega-3 fatty acids) to relieve symptoms. METHODS: In a multicenter, double-blind clinical trial, we randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3000 mg of fish-derived n-3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group). The primary outcome was the mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months. Secondary outcomes included mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer's test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs. RESULTS: A total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively. The mean change in the OSDI score was not significantly different between the active supplement group and the placebo group (-13.9 points and -12.5 points, respectively; mean difference in change after imputation of missing data, -1.9 points; 95% confidence interval [CI], -5.0 to 1.1; P=0.21). This result was consistent across prespecified subgroups. There were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, -0.2 to 0.1), corneal staining score (0.1 point; 95% CI, -0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, -0.1 to 0.5), and result on Schirmer's test (0.0 mm; 95% CI, -0.8 to 0.9). At 12 months, the rate of adherence to treatment in the active supplement group was 85.2%, according to the level of n-3 fatty acids in red cells. Rates of adverse events were similar in the two trial groups. CONCLUSIONS: Among patients with dry eye disease, those who were randomly assigned to receive supplements containing 3000 mg of n-3 fatty acids for 12 months did not have significantly better outcomes than those who were assigned to receive placebo. (Funded by the National Eye Institute, National Institutes of Health; DREAM ClinicalTrials.gov number, NCT02128763 .).

Handling regular and irregular astigmatism during cataract surgery.

PURPOSE OF REVIEW: There are several different approaches to handling regular and irregular astigmatism during cataract surgery, but still much debate on which solutions are most effective given unique patient circumstances. In this review, we examine recent literature and studies to highlight some of the most effective ways to plan preoperatively, manage regular and irregular astigmatism during cataract surgery, as well as managing postoperative complications. RECENT FINDINGS: Recent developments in technology have provided increased courses of action for astigmatism management during cataract surgery. Additional options of toric IOLs with presbyopic platforms, light adjustable lenses, intraocular pinhole lenses, online technological tools and platforms, wavefront or topographic laser technology, and phototherapeutic keratectomy are all effective solutions to managing regular and irregular astigmatism. In this review, we will explore optimal approaches for unique situations. SUMMARY: With increased technology, research, and methods, correcting regular and irregular astigmatism during cataract surgery is achievable in most patients. With in-depth preoperative planning, analysis of patient-specific factors, and a tailored approach, surgeons can obtain excellent uncorrected vision for patients.

Study design and baseline findings from the progression of ocular findings (PROOF) natural history study of dry eye.

BACKGROUND: The aim of this research is to initiate a 5-year natural history study of dry eye disease (DED) using objectively assessed and patient-reported outcomes, to explore the hypothesis that DED is a progressive condition that has substantive and measurable impacts not only on the ocular surface, but on quality of life and visual functioning. Our objective for this report is to examine the baseline data. METHODS: A multicenter, prospective, controlled, observational study of Level 2 (mild-to-moderate) DED patients based on International Task Force Delphi Panel severity grading, and controls, documented baseline measures (including tear film biomarkers and quality of life). Tear cytokine concentrations were also measured in the tear film. Patients were using artificial tears as needed. RESULTS: Two hundred seventeen DED patients and 67 gender- and age-matched controls were enrolled. A majority were females and Caucasian and groups did not differ significantly in terms of gender, race, or age. Differences between DED and matched controls, at baseline, included mean scores for Ocular Surface Disease Index (31.7 vs 4.1, P < 0.0001), Schirmer test (5.7 vs 15.3 mm, P < 0.0001), corneal staining (1.4 vs 0.2, P < 0.0001), conjunctival staining (1.4 vs 0.3, P < 0.0001), and tear break-up time (5.7 vs 8.5 s, P < 0.0001). Tear cytokines levels were determined and included interferon-γ, interleukin (IL)-1ß, IL-2, IL-4, IL-6, IL-8, tumor necrosis factor-α, epidermal growth factor, IL-13, IL-17, IL-1α, and inducible protein-10. The mean levels of IL-8 and IL-6 were slightly higher in the DED group at baseline. Blurred vision was reported as moderate/severe/very severe at baseline in 57.6% of DED patients vs.10.5% of normal controls (P < 0.0001). DED patients reported greater reductions in work and non-work productivity, as well as greater need for visits to ophthalmologists during the prior year. CONCLUSIONS: In this report of the baseline findings of a 5-year natural history study of DED, a striking disease burden is observed with regard to blurred vision, productivity, and visits to eye care practitioners in mild to moderate DED patients compared to normal subjects of similar ages and genders. TRIAL REGISTRATION: ClinicalTrials.gov NCT00833235 on January 30, 2009.

A novel explanation of corneal clouding in a bone marrow transplant-treated patient with Hurler syndrome.

One common complication of mucopolysaccharidosis I-Hurler (MPS1-H) is corneal clouding, which occurs despite current treatments, including bone marrow transplantation. Human corneas were obtained from a 14 year old subject with MPS1-H and visual disability from progressive corneal clouding despite a prior bone marrow transplant at age 2. This was compared to a cornea from a 17 year old donated to our eye bank after his accidental death. The corneas were analyzed microscopically after staining with Alcian blue, antibodies to collagen I, IV, VI, and α-smooth muscle actin. Differences in levels of expression of the indicated molecules were assessed. Corneas from Hurler and control mice were examined similarly to determine potential mechanistic overlap. The MPS1-H subject cornea showed elevations in mucopolysaccharide deposition. The MPS1-H and Hurler mice corneas showed increased and disorganized expression of collagen I and IV relative to the control corneas. The MPS1-H corneas also showed increased and disordered expression of collagen VI. Positive expression of α-smooth muscle actin indicated myofibroblast conversion within the MPS1-H cornea in both the patient and mutant mouse material compared to normal human and control mouse cornea. Increased deposition of collagens and smooth muscle actin correlate with corneal clouding, providing a potential mechanism for corneal clouding despite bone marrow transplantation in MPS1-H patients. It might be possible to prevent or slow the onset of corneal clouding by treating the cornea with drugs known to prevent myofibroblast conversion.

Financially efficient cataract surgery in today's healthcare environment.

PURPOSE OF REVIEW: To review the literature and create a concise evaluation and comment on the ways to provide financially efficient cataract surgery in a healthcare environment that produces significant challenges to providing care, while maintaining quality outcomes, safety, patient satisfaction, and employee satisfaction. RECENT FINDINGS: The recent reductions in reimbursement for cataract surgery have fueled an increased need to drive innovation in ways to be more financially efficient. At the same time, new technology in the field, especially as it relates to use of the femtosecond laser for portions of lens surgery, has increased the challenges in creating an efficient and cost-effective structure for providing care. SUMMARY: Cataract surgery is one of the most beneficial procedures for a patient's quality of life, and is one of the most common surgical procedures performed. At the same time, the current cost-effectiveness is quite high, and yet there are still ways to become more financially efficient in many centers providing cataract care.

Outcomes of photorefractive keratectomy enhancement after LASIK.

PURPOSE: To report the outcomes of photorefractive keratectomy (PRK) enhancement after LASIK for patients diagnosed as having hyperopic and myopic refractive errors. METHODS: In this retrospective case series at a single private practice in the United States, all patients undergoing PRK enhancement after LASIK were identified. Patients with visually significant cataract, non-plano targets, and follow-up of fewer than 226 days were excluded. The primary outcome measure was uncorrected distance visual acuity (UDVA) with secondary measures of corrected distance visual acuity (CDVA) and postoperative refractive error. Linear regression analysis was performed for actual versus targeted change in spherical equivalent. RESULTS: Mean UDVA improved from 20/39 to 20/24 for hyperopes (n = 14; P < .002) and from 20/45 to 20/22 for myopes (n = 29; P < .0000001) after enhancement. All patients had a UDVA of 20/40 or better at their most recent follow-up visit. Fifty percent of hyperopes and 65.5% of myopes were 20/20 or better. The mean refractive error for hyperopes changed from +1.10 ± 0.71 (range: +0.13 to +2.25 diopters [D]) to +0.38 ± 0.66 D (range: -0.75 to +1.38 D) and from -1.21 ± 0.61 (range: -3.25 to -0.38 D) to +0.34 ± 0.45 D (range: -0.25 to +1.75 D) for myopes. The manifest refraction cylinder decreased from 0.84 to 0.46 D in hyperopes (P = .02) and from 0.64 to 0.26 D in myopes (P < .002). CDVA was maintained in both groups, with only one patient in each worse than 20/20. There was a nonsignificant trend toward less haze in the patients receiving mitomycin C (5.1% vs 25%, P = .14). Linear regression showed a tendency toward overtreatment in the myopic group. CONCLUSIONS: PRK is safe and highly effective for patients who previously underwent LASIK and in whom the surgeon would prefer not to perform a flap-lift enhancement.

Presbyopia-correcting intraocular lenses and corneal refractive procedures: a review for retinal surgeons.

PURPOSE: To review the specific challenges and pitfalls that vitreoretinal surgeons may face when operating on eyes with presbyopia-correcting intraocular lenses or previous corneal refractive surgery. In addition, this review aims to familiarize vitreoretinal surgeons with specifications of currently available Food and Drug Administration-approved presbyopia-correcting intraocular lenses. METHODS: Review of current literature performed with PubMed for search terms "presbyopia," "correction," "IOL," "vitreoretinal," "challenges," and "surgical" both singly and in combination as well as closely related terms. RESULTS AND CONCLUSION: Specific intraoperative issues with presbyopia-correcting intraocular lenses that may be encountered include peripheral visualization, condensation, lens material issues particularly with silicone oil, decentration, Z-syndrome, and foveal image displacement. Every patient undergoing retinal surgery should also be asked about previous laser-assisted in situ keratomileusis/photorefractive keratectomy because those eyes require special attention to surface hydration and care to avoid epithelial removal if possible. Intracorneal ring segments and corneal inlays can cause effects similar to those of a small pupil. However, these can be managed with thorough preoperative evaluation and various intraoperative maneuvers. In addition, retinal physicians should be aware that macular disorders, such as age-related macular degeneration, may be exacerbated by potential loss of contrast sensitivity.

Descemet Stripping Endothelial Keratoplasty in Patients With a Custom Foldable Silicone Artificial Iris: Safety and Efficacy Outcomes.

PURPOSE: To assess outcomes of Descemet stripping endothelial keratoplasty (DSEK) in eyes with custom artificial iris (CAI) implantation. METHODS: This is a retrospective, interventional, consecutive, surgical case series of patients who underwent DSEK after CAI implantation between 2010 and 2021 at 2 referral centers. Primary safety measures were loss of corrected distance visual acuity (CDVA), increase in intraocular pressure (IOP), development or progression of glaucoma, and intraoperative and postoperative complications. Efficacy measures were graft survival at year 1 and improvement in cosmesis at postoperative month 3. In general, measures were compared between baseline and postoperative year 1 while any complication was reported for the full follow-up period. RESULTS: Thirty-nine eyes of 39 patients were identified. 64.1% of eyes had acquired aniridia from trauma. The mean follow-up interval was 27.7 months (range 12.2-117.4). Median CDVA improved from logMAR 1.0 to 0.7 at year 1 (P = 0.0047). At the final follow-up, permanent loss of CDVA occurred in 25.6% of eyes, of which 90% was due to glaucoma. The most common postoperative complication was IOP elevation (66.7% of eyes). Graft survival at postoperative year 1 was 82.0% (95% confidence interval, 66.3-91.4). Secondary graft failure occurred in 28.2% of eyes at a mean duration of 39.7 months (SD 27.9 months) after DSEK. Cosmesis improved among 87.2% of eyes at postoperative month 3. CONCLUSIONS: DSEK is an effective procedure for addressing corneal edema in eyes with a CAI, but a majority develop elevated IOP and graft survival is shorter than in eyes without a CAI.

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.

Rotation Characteristics of Three Toric Monofocal Intraocular Lenses.

PURPOSE: To evaluate the rotational stability of the three monofocal toric intraocular lenses (IOLs) via data from an online toric IOL back-calculator. METHODS: A retrospective data review of an online toric IOL back-calculator, which allows users to input preoperative toric planning information, postoperative lens orientation, and subjective refraction. Inputted data were used to determine the optimal orientation of the toric IOL to minimize residual refractive astigmatism. Aggregate data from 3/11/2019 to 3/10/2020 were extracted and validated. Only data with ≥0.5D of residual refractive astigmatism were used in the study. Pre-operative intended IOL orientation and post-operative IOL orientation were used to calculate IOL rotation. RESULTS: After validation, 5397 entries were determined to represent patient eyes, of which 3238 represented the three monofocal IOLs evaluated. The rate of rotation for AcrySof, TECNIS, and enVista Toric IOLs was 72.7%, 83.4%, and 83.0%, respectively, and location only significantly impacted TECNIS IOLs. The magnitude of rotation for rotated IOLs was similar for all models and was significantly more for IOLs initially placed in the oblique axis. All IOL models tended to rotate in a counterclockwise direction (53.2%, 73.0%, 69.7%, respectively; p<0.05), and the tendency was greater for IOLs initially located horizontally. CONCLUSION: The AcrySof IQ Toric IOL was more rotationally stable than both the TECNIS and enVista Toric IOLs; there was no significant difference in rotational stability of the latter two.

Wavefront-guided photorefractive keratectomy in eyes with prior radial keratotomy: a multicenter study.

PURPOSE: To investigate the outcomes of wavefront-guided photorefractive keratectomy (WG PRK) using prophylactic mitomycin C (MMC) in eyes that had previously undergone radial keratotomy (RK). DESIGN: Retrospective, observational, consecutive case series. PARTICIPANTS: Thirty-two eyes of 27 patients with previous RK that underwent WG PRK with MMC. METHODS: The records were reviewed of consecutive RK patients whose eyes underwent WG PRK with MMC in 4 centers with postoperative follow-up of 6 months or longer (range, 6-21 months). Eyes were divided into myopic WG PRK and hyperopic WG PRK groups based on their preoperative spherical equivalent (SE). Preoperative best spectacle-corrected visual acuity (BSCVA) was compared with postoperative uncorrected visual acuity (UCVA) and BSCVA to ascertain efficacy and safety. Change in SE and attempted versus achieved SE were evaluated. Incidences of haze and other complications were recorded. MAIN OUTCOME MEASURES: Uncorrected visual acuity, BSCVA, SE, corneal haze, and other complications. RESULTS: In the myopic WG PRK group (n = 9), UCVA improved by 3 lines on average (P = 0.015) with UCVA of > or =20/20 in 56% and > or =20/40 in 100% of eyes; 55% were within 0.5 diopter (D), and 100% were within 1 D of attempted refraction. In the hyperopic WG PRK group (n = 23), UCVA improved for 3 lines on average (P<0.001), with UCVA of > or =20/20 in 48% and > or =20/40 in 100% of eyes; 57% were within 0.5 D and 74% were within 1 D of attempted refraction. One eye lost 2 lines of BSCVA as a result of the development of mild to moderate haze, but recovered in 4 months. No eyes lost more than 2 lines of BSCVA. Six eyes (19%; 6/32) experienced the development of haze in the postoperative course, with mild to moderate haze in 1 eye and trace haze in the other 5 eyes. No other complications were noted. CONCLUSIONS: Wavefront-guided PRK with MMC in eyes with prior RK improved the UCVA significantly and was safe over the short follow-up of this series. Although haze occurred, no eye suffered persistent visual loss of 2 or more lines. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.

PURPOSE: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN: Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS: Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.

Effect of astigmatism on visual acuity after multifocal versus monofocal intraocular lens implantation.

PURPOSE: To determine whether there is a difference in how much residual astigmatism impacts uncorrected distance visual acuity (UDVA) after multifocal versus monofocal intraocular lens (IOL) implantation. SETTING: Database study. DESIGN: Retrospective data review. METHODS: An online toric IOL back-calculator allows users to input preoperative toric planning information and postoperative IOL orientation and refractive results. These data are used to determine the optimal orientation of the IOL to minimize residual refractive astigmatism. Aggregate data were extracted from this calculator to investigate factors associated with UDVA and relative magnitudes of residual astigmatic refractive error up to 2.5 diopters (D) after implantation of toric IOLs. RESULTS: Of 1919 pertinent records (455 multifocal toric IOLs and 1464 monofocal toric IOLs), a statistically significant difference by refractive cylinder category (P < .01) and a statistically significant difference by IOL type (P = .042) were noted. This difference was mostly driven by patients with residual refractive astigmatism of 1.5 D. The mean change in UDVA was 0.16 logarithm of the minimum angle of resolution per 1.0 D of astigmatism. Evaluating a more homogenous dataset with the same monofocal and multifocal IOL design, there was a statistically significant effect of refractive cylinder (P < .01) but no significant effect of IOL type (monofocal or multifocal, P = .45). The differences in UDVA at different refractive cylinder values was not statistically significantly different by orientation of the current astigmatism (P = .28). CONCLUSION: Residual astigmatism after toric IOL implantation impacts visual acuity similarly in patients who had multifocal and monofocal toric IOL implantation.

Factors Associated With Residual Astigmatism After Toric Intraocular Lens Implantation Reported in an Online Toric Intraocular Lens Back-calculator.

PURPOSE: To evaluate factors associated with residual astigmatism after toric intraocular lens implantation based on data from an online toric intraocular lens (IOL) back-calculator. METHODS: This was a retrospective data review of an online toric IOL back-calculator, which allows users to input preoperative toric planning information and postoperative lens orientation and refractive results. These data were used to determine the optimal orientation of the IOL to minimize residual refractive astigmatism. Aggregate data were extracted from this calculator to investigate factors associated with relative magnitudes of residual astigmatic refractive error after implantation of toric IOLs. RESULTS: A total of 3,159 validated records with an average reported postoperative refractive astigmatism of 1.85 diopters (D) were analyzed; 566 included data allowing calculation of surgically induced astigmatism. The relative magnitude of reported residual astigmatism appeared similar whether a femtosecond laser system was used or not. Significant differences relative to the use of intraoperative aberrometry were observed, as were differences by toric calculator. Higher measured surgically induced astigmatism was most associated with higher levels of reported residual astigmatism. A significant potential decrease in the mean refractive astigmatism was expected with IOL reorientation; in 1,416 cases (44.8%), the expected residual refractive astigmatism after lens reorientation was less than 0.50 D, with a mean reduction of 56% ± 31%. CONCLUSIONS: When present after cataract surgery, higher levels of residual refractive astigmatism were most associated with large differences in measured preoperative to postoperative keratometry. To a lesser degree, intraoperative aberrometry was associated with lower levels. [J Refract Surg. 2018;34(6):366-371.].

Retreatment after LASIK using epithelial ablation alone.

PURPOSE: Retreatments after refractive surgery may be associated with complications similar to the original surgical procedure. Excimer laser ablation of the epithelium may be associated with fewer complications and may prevent the need for flap-lift retreatment after LASIK. METHODS: A retrospective chart review identified eyes that had undergone epithelial retreatments after primary LASIK. Treatment was performed with excimer laser correction on a dry intact epithelium. RESULTS: Of the 27 eyes that were treated in this fashion, 8 (29.6%) eyes went on to subsequent flap-lift retreatment. The most common complication at 1 day was punctate keratopathy (7 eyes, 25.9%). No eyes lost best spectacle-corrected visual acuity during follow-up. CONCLUSIONS: The high rate of subsequent flap-lift retreatment, as well as the lack of statistically significant changes in refractive error, will limit the usefulness of epithelial retreatments. Because of the low incidence of complications, improvement in a small number of patients, and the lack of desire of some patients to undergo further flap-lift retreatment, epithelial retreatment may be useful in some eyes with minimal residual refractive error after LASIK.

Clinicopathologic correlation of explanted AlphaCor artificial cornea after exposure of implant.

PURPOSE: To describe the clinical presentation and histopathologic findings in a case of explantation of an AlphaCor artificial cornea implant caused by exposure of the skirt. METHODS: We describe the case report of a 46-year-old man who suffered trauma to the right eye, resulting in 4 failed penetrating keratoplasties (PKPs). Subsequently, an AlphaCor implantation was performed with some visual improvement. Slightly more than 2 years after the implant, skirt exposure occurred, possibly secondary to infectious keratitis in an area of a ruptured bulla, and explantation was performed. Corneal stability was established with repeat corneal transplantation. RESULTS: Histopathologic evaluation of the surgical specimen revealed chronic nongranulomatous inflammation and fibrosis in the peripheral skirt, indicating that biointegration was maintained. However, peripheral corneal stromal melting led to skirt exposure. Focal calcification, as well as retroprosthetic membrane formation, was also identified. CONCLUSIONS: The AlphaCor implant is a viable method of treatment for multiple failed PKPs, but it may be associated with unique complications, including corneal stromal melting, focal calcification, and retroprosthetic membrane formation. Infectious keratitis may be a risk factor for corneal stromal melting and needs to be managed aggressively. Explantation of the implant is essential if the skirt is exposed.

The Effect of Lens Sphere and Cylinder Power on Residual Astigmatism and Its Resolution After Toric Intraocular Lens Implantation.

PURPOSE: To analyze correlations between residual refractive cylinder (and its correction through lens reorientation) with the sphere and cylinder power of the toric intraocular lens (IOL) implanted. METHODS: An online toric back-calculator (www.astigmatismfix.com) allows users to input toric IOL planning data, along with postoperative IOL orientation and refractive results; these data are used to determine the optimal orientation of the IOL to reduce refractive astigmatism. This was a retrospective data analysis; aggregate historical data were extracted from this calculator to investigate the relationship between residual refractive astigmatism and IOL cylinder and sphere power. RESULTS: A total of 12,812 records, 4,619 of which included IOL sphere power, were available for analysis. There was no significant effect of sphere power on residual refractive astigmatism (P = .25), but lower IOL cylinder powers were associated with significantly lower residual refractive astigmatism (P < .05). The difference between the intended and ideal orientation was higher in the lower IOL cylinder power groups (P < .01). Overcorrection of astigmatism was significantly more likely with higher IOL cylinder power (P < .01), but not with sphere power (P = .33). Reorientation to correct residual refractive cylinder to less than 0.50 diopters (D) was more successful with IOL cylinder powers of 1.50 D or less (P < .01); IOL sphere power had no apparent effect. CONCLUSIONS: There were significant effects of IOL cylinder power on residual refractive astigmatism, the difference between intended and ideal orientation, the likelihood of overcorrection, and the likelihood of astigmatism reduction with lens reorientation. IOL sphere power appeared to have no such effects. [J Refract Surg. 2017;33(3):157-162.].

Enhancing intraocular lens outcome precision: an evaluation of axial length determinations, keratometry, and IOL formulas.

Accurate biometry and intraocular lens (IOL) calculations have consequence in patient satisfaction and depend on correct determination of eye length, IOL position, refractive power of the cornea, and selection of the proper IOL formula. Familiarity with these variables will make it easier to achieve precise results in both the intact eyes and eyes that have had previous surgeries, including keratorefractive procedures. This articles provide practical tips and methods to avoid refractive surprises.