Rosacea Core Domain Set for Clinical Trials and Practice: A Consensus Statement.

Importance: Inconsistent reporting of outcomes in clinical trials of rosacea is impeding and likely preventing accurate data pooling and meta-analyses. There is a need for standardization of outcomes assessed during intervention trials of rosacea. Objective: To develop a rosacea core outcome set (COS) based on key domains that are globally relevant and applicable to all demographic groups to be used as a minimum list of outcomes for reporting by rosacea clinical trials, and when appropriate, in clinical practice. Evidence Review: A systematic literature review of rosacea clinical trials was conducted. Discrete outcomes were extracted and augmented through discussions and focus groups with key stakeholders. The initial list of 192 outcomes was refined to identify 50 unique outcomes that were rated through the Delphi process Round 1 by 88 panelists (63 physicians from 17 countries and 25 patients with rosacea in the US) on 9-point Likert scale. Based on feedback, an additional 11 outcomes were added in Round 2. Outcomes deemed to be critical for inclusion (rated 7-9 by ≥70% of both groups) were discussed in consensus meetings. The outcomes deemed to be most important for inclusion by at least 85% of the participants were incorporated into the final core domain set. Findings: The Delphi process and consensus-building meetings identified a final core set of 8 domains for rosacea clinical trials: ocular signs and symptoms; skin signs of disease; skin symptoms; overall severity; patient satisfaction; quality of life; degree of improvement; and presence and severity of treatment-related adverse events. Recommendations were also made for application in the clinical setting. Conclusions and Relevance: This core domain set for rosacea research is now available; its adoption by researchers may improve the usefulness of future trials of rosacea therapies by enabling meta-analyses and other comparisons across studies. This core domain set may also be useful in clinical practice.

Spherical Aberration of Cataractous Eyes and Its Relationship With Age, Ocular Biometry, and Various IOL Platforms.

PURPOSE: To determine the median spherical aberration (SA) of the cataractous population, how it relates to biometry, and the theoretical effect of different intraocular lens (IOL) platforms. METHODS: A retrospective chart review of patients undergoing cataract surgery evaluation with a high quality Pentacam (Oculus Optikgeräte GmbH) were included. Age, gender, Q-value, mean total SA, higher order aberration root mean square wavefront error, and equivalent keratometry were collected from the Holladay report and axial length and anterior chamber depth (ACD) from the IOLMaster 700 (Carl Zeiss Meditec AG). RESULTS: Data from 1,725 eyes of 999 patients were collected. SA had a median of 0.37 µm (95% confidence interval: 0.36 to 0.38. Age (r = .136, P < .001), Q-factor (r = .743, P < .001), and higher order aberration root mean square wavefront error (r = .307, P < .001) were positively correlated with SA. Average equivalent keratometry (r = -.310, P < .001) was negatively correlated with SA. Axial length (r = -0.037, P = .120) and ACD (r = .004, P = .856) had no association with SA. Up to 1,499 (86.9%) theoretically had SA moved closer to zero with IOLs that had negative SA. Up to 102 (5.9%) had SA theoretically worsened. CONCLUSIONS: SA is not normally distributed, suggesting that there may be no "average" SA that IOLs should aim to correct. Patients might benefit from tailoring IOL choice to individual SA. Without access to SA data, eyes with steeper average keratometry or younger patients may have less SA, which could influence IOL choice. [J Refract Surg. 2023;39(2):89-94.].

Subject Satisfaction with Trifarotene 50 µg/g Cream in the Treatment of Facial and Truncal Acne Vulgaris: A Case Series.

There is a paucity of literature covering patient-reported outcomes of treatments for truncal acne. Trifarotene 50 µg/g cream is a novel retinoid molecule approved for once-daily topical treatment of facial and truncal acne vulgaris. As physicians are starting to gain real-world experience with this retinoid treatment, their access to reporting from the patient's perspective provides a valuable adjunct to the pivotal studies. We report a case series of three subjects with moderate facial and truncal acne treated with trifarotene 50 µg/g cream on the face, shoulders, upper back and upper anterior chest for 12 weeks and evaluated by satisfaction questionnaires. This case series illustrating the treatment of facial and truncal acne with trifarotene 50 µg/g cream, in the form of real-world data, describes high overall satisfaction and excellent tolerability to support the use of this new retinoid molecule in the treatment of acne vulgaris on both the face and trunk.

Spectrum of Angle Closure, Uveal Effusion Syndrome, and Nanophthalmos.

Nanophthalmos, uveal effusion syndrome, and acute angle closure glaucoma (ACG) can present as a continuum in a patient, as is described here. This patient's angle closure was thought to be caused by idiopathic uveal effusion syndrome, and while there are no generally accepted diagnosis criteria for nanophthalmos, our patient fulfilled the criteria as defined by Wu.10 To prevent development of further angle closure, the decision was made to do cataract extraction as opposed to medical management. HOW TO CITE THIS ARTICLE: Areiter E, Neale M, Johnson SM. Spectrum of Angle Closure, Uveal Effusion Syndrome, and Nanophthalmos. J Curr Glaucoma Pract 2016;10(3):113-117.

Complications of inadvertent filtering blebs after cataract extraction.

UNLABELLED: We report 2 cases of inadvertent filtering blebs that developed vision-threatening complications many years after uneventful cataract extraction with scleral incisions. These inadvertent blebs can create complications similar to the intentionally produced blebs from trabeculectomy surgery; thus, follow-up and management should be handled in a similar manner. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Efficacy and patient tolerability of travoprost BAK-free solution in patients with open-angle glaucoma and ocular hypertension.

The medical treatment of glaucoma has evolved significantly over the past several decades. The main driving forces behind this evolution are the safety profiles and efficacy of these medications. Prostaglandin (PG) analogues are shown to be superior to older drugs in both efficacy and tolerability. Though there are much fewer side effects that manifest after using PG analogues, the adherence and compliance to medication regimens are surprisingly lower than expected. A commonly sited reason is the ocular irritation and inflammation with these medications. Much of this inflammation can be attributed to the preservative, benzalkonium chloride (BAK). The chronic clinical and subclinical inflammation becomes increasingly detrimental when filtration surgery fails from bleb fibrosis secondary to this hypercellularity. A BAK-free formulation of a PG analogues recently became available. BAK-free travoprost is reviewed here. It has demonstrated equal efficacy and less ocular surface toxicity than its preserved counterparts. It is expected to serve as an instrumental resource in managing ocular hypertension and glaucoma in patients who demonstrate significant sensitivity to BAK. More randomized, controlled, double-blind studies are encouraged to evaluate its improved safety and tolerability.

Intralesional immunotherapy of warts with mumps, Candida, and Trichophyton skin test antigens: a single-blinded, randomized, and controlled trial.

BACKGROUND: Warts occur commonly in humans. Destructive modalities are generally the first physician-administered therapy. Other treatment options include immunotherapy. Intralesional immunotherapy using mumps, Candida, or Trichophyton skin test antigens has proved efficacy in the treatment of warts. OBJECTIVES: To determine rates of wart resolution in response to injection of antigen alone, antigen plus interferon alfa-2b, interferon alfa-2b alone, and normal saline; and to compare response according to viral type, major histocompatibility complex antigens, and peripheral blood mononuclear cell proliferation to autologous human papillomavirus antigen before and after injection. DESIGN: Randomized, single-blinded, placebo-controlled, clinical trial. SETTING: Medical school-based dermatology department. PATIENTS: Two hundred thirty-three patients clinically diagnosed as having 1 or more warts. Main Outcome Measure Clinical resolution of warts in response to intralesional immunotherapy. RESULTS: Responders were observed in all treatment arms, but were significantly more likely to have received antigen (P<.001). Resolution of distant untreated warts was observed, and was significantly more likely in subjects receiving antigen (P<.001). Interferon did not significantly enhance the response rate (P = .20) and did not differ from normal saline (P = .65). No viral type or major histocompatibility complex antigen correlated with response or lack of response (P>.99 and P = .86, respectively). A positive peripheral blood mononuclear cell proliferation assay result (2 times pretreatment levels) was significantly more likely among responders (P = .002). While there was no significant difference in response based on sex (P = .56), older subjects (>40 years) were less likely to respond (P = .01). CONCLUSIONS: Intralesional immunotherapy using injection of Candida, mumps, or Trichophyton skin test antigens is an effective treatment for warts, as indicated by significantly higher response rates and distant response rates in subjects receiving antigen. Viral type and major histocompatibility complex antigens did not seem to influence treatment response. Response is accompanied by proliferation of peripheral blood mononuclear cells to human papillomavirus antigens, suggesting that a human papillomavirus-directed cell-mediated immune response plays a role in wart resolution.

Lateral tarsorrhaphy for prevention of postoperative complications resulting from globe luxation.

We present a case of spontaneous globe luxation and wound dehiscence that developed in a patient with proptosis 1 day after phacoemulsification with posterior chamber intraocular lens implantation. The wound was repaired and a lateral tarsorrhaphy was performed with successful prevention of further luxations. Upon cataract extraction in the patient's other eye, lateral tarsorrhaphy was performed concurrently to prevent operative complications. This report underscores the importance of lateral tarsorrhaphy performed at the time of cataract surgery to avoid postoperative globe luxation with possible wound dehiscence in patients with proptosis or shallow orbits and a history of luxation.