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.