Category: Peer-reviewed

Erratum

Please note that one of the authors’ degrees in the publication entitled, “Lessons in Corneal Structure and Mechanics to Guide the Corneal Surgeon” (Ophthalmology 2013;120:1715-1717) had errors. The correct degrees for Dr. Jan P.G. Bergmanson shoul…

This Issue At A Glance

Young et al (p. 2390) compared the long-term outcome of limbal conjunctival autograft (LCAU) with that of intraoperative applications of mitomycin C (MMC) in minimizing pterygium recurrence. They also evaluated the effects of MMC on corneal endothelia…

Author reply

We appreciate Suelves, Gregori, and Diaz-Llopis’ interest in our recent article “A National Survey of Practice Patterns: Temporal Artery Biopsy.” In this study, we surveyed neuro-ophthalmologists, oculoplastic surgeons, and rheumatologists regarding temporal artery biopsy practices in the assessment of patients suspected to have giant cell arteritis (GCA). Specifically, we questioned practitioners as to whether they favored unilateral or bilateral temporal artery biopsy and their thoughts regarding the effect of prior corticosteroid therapy on biopsy findings. In short, responses varied greatly within and between specialists. Of slightly >1000 respondents, 37% recommended unilateral biopsy alone, 29% recommended initial unilateral biopsy with biopsy of the contralateral side if the first side is negative, 18% recommended bilateral biopsy in all cases, and 16% stated that their preference depended on the degree of suspicion. Most respondents believed that biopsies remained accurate for >14 days after initiating steroid therapy.

Reply

Thank you very much for your comments concerning our article, Surgical Results of a Muscle Transposition Procedure for Abducens Palsy without Tenotomy and Muscle Splitting. As you pointed out, in Figure 3, the eyes of patient 7 in right gaze seem to…

Reporting Visual Acuities

The AJO encourages authors to report the visual acuity in the manuscript using the same nomenclature that was used in gathering the data provided they were recorded in one of the methods listed here. This table of equivalent visual acuities is provided…

Reply

We thank the authors for their interest in our recently published article. This study was strictly a microbiological study using data from the microbiology department. These data did not include any clinical information regarding etiology of endophthal…

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We thank Abramson and associates for their comments regarding our report and welcome the opportunity to clarify our conclusions. In our study, only 1 of 252 patients that had received systemic chemotherapy developed pineoblastoma, while 3 of 156 patien…

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The authors appreciate the questions posed by Drs. Carifi, Zygoura, Deshmuck, and Kopsakilis regarding the issues of capsule-optic overlap and whether intraoperative bleeding, iris trauma, or postoperative inflammation were considered as exclusion crit…

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I have been involved at every stage in the development of the Neusidl Corneal Inserter (NCI), from the moment that a talented ophthalmologist and innovative engineer, William Neusidl, showed me his initial drawings, through laboratory testing and revis…

Endothelial Keratoplasty: Prospective, Randomized, Masked Clinical Trial Comparing an Injector With Forceps for Tissue Insertion

In regard to the recent paper by Terry and associates, I would like to point out a potential mitigating factor that limits the clinical applicability of the paper. Although the authors state, “All other steps of the surgical procedure were exactly the same,” this is not precisely correct. The authors utilized viscoelastic protection for the Charlie II forceps (Bausch & Lomb Surgical, St. Louis, Missouri, USA) group and did not utilize any viscoelastic for the Neusidl Cornea Inserter (Fischer Surgical, Imperial, Missouri, USA) group, stating that viscoelastic is not part of the standard operating procedure for the Neusidl Cornea Inserter. The authors are confusing standard or typical use with what a manufacturer can list in its labeling. As the authors know, the Charlie forceps did not require any clinical data to support its marketing and, as such, the companies do not supply any use information or suggest the use of a viscoelastic. The procedure used by the authors is their standard of practice for the Charlie forceps and not a manufacture-supplied procedure. The Food and Drug Administration (FDA) required extensive clinical data from Fischer Surgical prior to their marketing of the Neusidl Cornea Inserter. The procedure the authors followed is not typical of the standard practice with the Neusidl Cornea Inserter, in which the majority of surgeons utilize viscoelastic. The original Neusidl Cornea Inserter standard operating procedure included the optional use of viscoelastic protection but that information was removed for the submission. The lack of viscoelastic use in the FDA protocol (personal communication) was based on limiting variables and potentially further data requests from the FDA as well as the belief that cell loss without viscoelastic would still be at an acceptable level. A proper or more comparative study would have used viscoelastic in both arms to better reflect the different insertion devices and techniques and would then have been more clinically meaningful.

Lifitegrast Ophthalmic Solution 5.0% for Treatment of Dry Eye Disease: Results of the OPUS-1 Phase 3 Study – Corrected Proof

Purpose: To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry eye disease.Design: Prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial.Participants: A total of 588 adult subjects with dry eye disease.Methods: Eligible subjects were randomized 1:1 to receive topically administered lifitegrast (5.0%) or placebo (vehicle) twice daily for 84 days after a 14-day open-label placebo run-in period. After enrollment (day 0), subjects were evaluated at days 14, 42, and 84. Key objective (fluorescein and lissamine staining scores [Ora scales]) and subjective (Ocular Surface Disease Index [OSDI], 7-item visual analog scale, and ocular discomfort score [Ora scale]) measures were assessed at all visits.Main Outcome Measures: The primary objective efficacy measure (sign) was mean change from baseline inferior corneal staining score (ICSS) at day 84. The co-primary subjective efficacy measure (symptom) was the mean change from baseline in the visual-related function subscale score of the Ocular Surface Disease Index (VR-OSDI). Supportive measures included corneal fluorescein scores (superior, central, total region) and conjunctival lissamine scores (nasal, temporal, total region) and symptom scores at day 84.Results: The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo (P = 0.0007). Lifitegrast significantly reduced corneal fluorescein staining (superior, P = 0.0392; total cornea, P = 0.0148) and conjunctival lissamine staining (nasal, P = 0.0039; total conjunctiva, P = 0.0086) at day 84 versus placebo. Significant (P < 0.05) improvements in nasal and total lissamine scores were observed at day 14 and maintained through day 84. The study did not meet the co-primary subjective VR-OSDI measure (P = 0.7894). However, significant improvements were observed at day 84 in ocular discomfort (P = 0.0273) and eye dryness (P = 0.0291), the most common and severe symptoms reported at baseline in both groups. There were no unanticipated or serious ocular adverse events (AEs). The most frequent reported ocular AEs were transient intermittent instillation site symptoms (irritation, discomfort) primarily on the initial lifitegrast dose at day 0.Conclusions: Lifitegrast ophthalmic solution 5.0% significantly reduced corneal fluorescein and conjunctival lissamine staining and improved symptoms of ocular discomfort and eye dryness compared with placebo when administered twice daily over 84 days.Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.