John Hovanesian

Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes.

PURPOSE To report 1-year safety and efficacy clinical outcomes of a shape-changing corneal inlay for the treatment of presbyopia. DESIGN Prospective, nonrandomized, multicenter United States Food and Drug Administration Investigational Device Exemption clinical trial (clinicaltrials.gov identifier, NCT01373580). PARTICIPANTS Nondominant eyes (N = 373) of emmetropic presbyopic subjects were implanted at 11 sites with the Raindrop Near Vision Inlay (ReVision Optics, Lake Forest, CA); 340 eyes underwent the 1-year follow-up visit. METHODS The corneal inlay was implanted under a corneal flap at the center of the light-constricted pupil created with a femtosecond laser. MAIN OUTCOME MEASURES For subjects completing the 1-year follow-up, monocular and binocular uncorrected and corrected visual acuity, refractive stability, contrast sensitivity (CS; photopic and mesopic), symptom and satisfaction questionnaire results, and adverse events. RESULTS At 1 year in the treated eye, on average, uncorrected near visual acuity (UNVA) improved by 5.1 lines, uncorrected intermediate visual acuity (UIVA) improved by 2.5 lines, and uncorrected distance visual acuity (UDVA) decreased by 1.2 lines. From 3 months through 1 year, 93% of subjects achieved UNVA of 20/25 or better, 97% achieve UIVA of 20/32 or better, and 95% achieved UDVA of 20/40 or better. Binocularly, the mean UDVA exceeded 20/20 from 3 months through 1 year. Contrast sensitivity loss occurred only at the highest spatial frequencies, with no loss binocularly. Absent or mild scores were reported in 96% of subjects for visual symptoms (glare, halos, double vision, and fluctuations in vision), in 99% for ocular symptoms (pain, light sensitivity, and discomfort), and in 95% for dryness. Adverse events were treatable and resolved. Eighteen inlays were replaced, usually soon after implantation because of decentration, but UNVA was little affected in this group thereafter. In the 11 cases requiring inlay explantations, 100% achieved a corrected distance visual acuity of 20/25 or better by 3 months after explant. CONCLUSIONS The Raindrop Near Vision Inlay provides significant improvement in near and intermediate visual performance, with no significant change in binocular distance vision or CS. Subject satisfaction is improved significantly with minimal ocular or visual symptoms.

Hydrogel sealant versus sutures to prevent fluid egress after cataract surgery

Purpose To evaluate the effectiveness of a hydrogel sealant versus a suture in preventing fluid egress after wound leakage in cataract surgery. Setting Twenty‐four ophthalmic clinical practices in the United States. Design Prospective randomized parallel‐arm controlled multicenter subject‐masked study. Methods Healthy patients having uneventful clear corneal incision (CCI) cataract surgery were eligible for the study. Spontaneous and provoked fluid egress from wounds was evaluated at the time of surgery using a calibrated force gauge. Eyes with leakage were randomized to receive a hydrogel sealant (Resure) or a nylon suture at the main incision site. Incision leakage was reevaluated 1, 3, 7, and 28 days postoperatively. Results Of 500 eyes, 488 had leakage at the time of cataract surgery. The leak was spontaneous in 244 cases (48.8%), and 488 (97.6%) of all incisions leaked with 1.0 ounce or less of applied force. After randomization, 12 (4.1%) of 295 eyes in the sealant group and 60 (34.1%) of 176 eyes in the suture group had wound leakage with provocation (P<.0001). The overall incidence of adverse ocular events was statistically significantly lower in the sealant group than in the suture group (P<.05). Conclusions In this study, 97.6% of CCIs leaked after cataract surgery. The hydrogel sealant was safe and effective and better than a suture for the intraoperative management of CCIs with leakage as seen on Seidel testing and for the prevention of postoperative fluid egress. Financial Disclosure Proprietary or commercial disclosures are listed after the references.

Randomized comparison of postoperative use of hydrogel ocular bandage and collagen corneal shield for wound protection and patient tolerability after cataract surgery

PURPOSE: To compare the safety and efficacy of a hydrogel bandage and a collagen corneal shield in providing wound protection and relief of pain/discomfort in the acute period after uneventful unilateral clear corneal phacoemulsification cataract surgery with foldable intraocular lens (IOL) implantation. SETTING: Seventeen investigational sites in the United States. DESIGN: Prospective randomized single‐masked parallel study. METHODS: The study comprised patients scheduled to have unilateral clear corneal cataract surgery with posterior chamber intraocular lens implantation. The patients were examined preoperatively and frequently for 30 days postoperatively. The design was a noninferiority study of the 2 primary endpoints, device performance and maximum reported postoperative pain. RESULTS: The device performance success was 78.6% (228/290) for the hydrogel bandage and 26.5% (26/98) for the corneal shield (P<.0001 for noninferiority). Analyses indicated that the hydrogel bandage was superior to the corneal shield in device performance (P<.001; difference = 52.1%; 95% confidence interval, 41.6%‐61.4%). The maximum postoperative pain/discomfort score of the hydrogel bandage (mean 1.3 ± 1.8 [SD]; scale 0 to 10) was noninferior to that of the corneal shield (1.1 ± 1.6) in the first 4 hours after surgery (P<.001). Adverse events in the cataract surgeries were reported in 22.2% (70/316) and 36.5% (38/104) of hydrogel bandage patients and corneal shield patients, respectively (P = .0045). CONCLUSION: The hydrogel bandage was safe and effective for ocular surface protection and relief of pain/discomfort when applied topically to clear corneal incisions used in cataract or IOL implantation surgery. Financial Disclosure: No author has a financial or proprietary interest in any material or method mentioned. Additional disclosures are found in the footnotes.

Use of a calibrated force gauge in clear corneal cataract surgery to quantify point-pressure manipulation

Purpose To develop and evaluate a calibrated force gauge designed to simulate the effect of patient‐induced manipulation of the eye with resultant elevation of intraocular pressure (IOP) and use the device to determine the stability of cataract incisions. Setting Three private practice study sites. Design Clinical trials. Methods A calibrated force gauge was developed to apply controlled and quantifiable amounts of force to the eye. In study 1, the calibrated force gauge was used to evaluate the change in IOP during application of 1 oz of external force in a group of healthy volunteers. In studies 2 and 3, the calibrated force gauge was used to assess wound leakage of clear corneal incisions that were subjected to stromal hydration or sutures, respectively. Results In study 1, with the application of 1.00 oz of external force, the mean IOP rose from a baseline of 17.49 mm Hg to 43.44 mm Hg. In study 2 (stromal hydration) using up to 1.00 oz of force, the leak rate was 67% for the main incision. The overall leak rate for study 3 (sutures) using up to 1.00 oz of force was 23.8%. No adverse events or serious adverse events occurred during these studies. Conclusions Study 1 confirmed that 1.00 oz of force is a realistic approximation of the amount of force a patients eye may experience during rubbing. After clear corneal cataract surgery, the application of 1.00 oz of force to the ocular surface for approximately 2 to 3 seconds may simulate the propensity for postoperative wound leak resulting from patient manipulation. Financial Disclosure Drs. Masket, Hovanesian, and Raizman are consultants to Ocular Therapeutix. Dr. Masket is also a medical monitor for Ocular Therapeutix. Drs. Hovanesian and Masket are shareholders in Ocular Therapeutix. Drs. Wee and Fram have no financial disclosures.

Safety and effectiveness of a new toric presbyopia-correcting posterior chamber silicone intraocular lens.

Purpose To evaluate the safety and effectiveness of the Trulign toric intraocular lens (IOL) in adults with cataract. Setting Eight private practices in the United States and 1 in Canada. Design Prospective randomized single‐masked multicenter study. Methods A toric IOL (1.25 D, 2.00 D, or 2.75 D, determined by a toric calculator) was implanted in eligible patients with age‐related cataract requiring a 16.00 to 27.00 diopter (D) spherical IOL power and with a predicted postoperative astigmatism of 0.83 to 2.50 D. Eyes within the lowest cylinder range (predicted postoperative astigmatism 0.83 to 1.32 D) were randomized in a 1:1 ratio between the 1.25 D toric IOL group and the nontoric accommodating IOL (Crystalens) control group. Results The toric 1.25 D group had a statistically significantly greater percentage reduction in absolute cylinder (P < .001) and uncorrected distance visual acuity (P = .002) than the control group at the 120‐ to 180‐day visit. The mean monocular uncorrected vision at distance, intermediate, and near was 20/25, 20/22, and 20/39, respectively, with the 1.25 D, 2.00 D, and 2.75 D toric IOLs in aggregate (toric group). In addition, 96.1% of patients (123/128) had 5.0 degrees or less absolute IOL rotation postoperatively. Regarding safety, the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met. Conclusion The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision. Financial Disclosures Dr. Pepose is a consultant to Bausch & Lomb and was medical monitor of this study. Drs. Buckhurst, Whitman, Feinerman, Hovanesian, Davies, Labor, and Carter are consultants to Bausch & Lomb. At the time of the study, Drs. Hayashida, and Khodai were employees of Bausch & Lomb. Drs. Colvard and Mittleman have financial or proprietary interest in any material or method mentioned.

Current knowledge about and recommendations for ocular methicillin-resistant Staphylococcus aureus.

UNLABELLED Staphylococcus aureus is the most important and common pathogen that infects patients following cataract surgery, laser in situ keratomileusis, and photorefractive keratectomy. It is reported to be the second most common pathogen causing bacterial keratitis around the world. Of special concern are increasing reports of postoperative methicillin-resistant S aureus (MRSA) infection. For example, MRSA wound infections have been reported with clear corneal phacoemulsification wounds, penetrating keratoplasty, lamellar keratoplasty, and following ex vivo epithelial transplantation associated with amniotic membrane grafts. These and other data suggest that MRSA has become increasingly prevalent worldwide. In this article, we review the current medical literature and describe the current challenge of ocular MRSA infections. Recommendations are made based on an evidence-based review to identify, treat, and possibly reduce the overall problem of this organism. FINANCIAL DISCLOSURE No author has a financial or proprietary interest in any material or method mentioned.

Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies

Background: These studies evaluated the safety and efficacy of a single-dose sustained release dexamethasone depot (DEXTENZA™, Intracanalicular Depot) for the treatment of pain and inflammation following cataract surgery. Methods: Patients were randomized (2:1) on Day 1 to receive a sustained release dexamethasone depot, (0.4 mg; Study 1, n=164; Study 2, n=161) or placebo vehicle depot (Study 1, n=83; Study 2, n=80) in the inferior canaliculus. Results: A significantly greater proportion of patients in the dexamethasone groups (Study 1, 80.4% [131/164] vs. 43.4% [36/83], P<0.0001; Study 2, 77.5% [124/161] vs. 58.8% [47/80], P=0.0025) had an absence of ocular pain at Day 8. At Day 14 more patients in the dexamethasone groups had an absence of anterior chamber cells (Study 1, 33.1% [54/164] vs. 14.5% [12/83], P=0.0018; Study 2, 39.4% [63/161] vs. 31.3% [25/80], P=0.2182). Statistically significant differences favoring dexamethasone were observed in both studies for proportions of patients with: an absence of ocular pain at days 2, 4, 8, and 14; an absence of anterior chamber flare at days 8 and 14; mean anterior cell scores at days 8 and 14. Significantly fewer patients in the dexamethasone groups required rescue medications on days 8 and 14. No serious adverse events related to treatment occurred in either group. Transient IOP increases of ≥ 10 mmHg in the study eye were observed in similar proportions of patients in the sustained release dexamethasone groups, (6.8% in Study 1 and 4.4% in Study 2) and the placebo groups (3.6% and 5.0%, respectively). However, only 1 incidence of IOP elevation was thought to be product related (0.3%). Conclusions: These two studies demonstrate that a single dose, sustained release dexamethasone intracanalicular depot is safe and effective for the treatment of ocular pain and inflammation following cataract surgery.

Through-focus performance with a corneal shape-changing inlay: One-year results.

Purpose To evaluate improvement in the through‐focus acuity and visual function provided by a corneal inlay designed to modify the surface shape of the central cornea. Setting Two clinical practices, United States. Design Prospective nonrandomized clinical trial. Methods Emmetropic patients with presbyopia who required a reading addition (add) from +1.50 to +2.00 diopters (D) had implantation of the Raindrop Near Vision Inlay in the nondominant eye. The inlay was designed to modify the anterior curvature of the central cornea with the intent to improve near and intermediate vision. At the preoperative and 1‐year postoperative visits, the following visual functions were recorded: defocus curves in the nondominant eye, required add for best near vision, distance‐corrected binocular contrast sensitivity, and uncorrected and corrected visual acuity at 6 m, 80 cm, and 40 cm. Results The study comprised 30 patients. One year postoperatively, on average, distance‐corrected near acuity improved by more than 3 lines, with patients achieving a distance‐corrected acuity of 0.3 logMAR (20/40) or better across a 3.50 D range of defocus. Binocular uncorrected visual acuity of 0.2 logMAR (20/32) or better at distance, intermediate, and near distances was obtained in 97% of patients. The mean reduction in the reading add was 1.60 D. There was no significant change in binocular contrast sensitivity. Overall patient satisfaction was high. Conclusion A corneal inlay in the nondominant eye of emmetropic patients provided a significant increase in the range of functional vision at intermediate and near, with no loss in binocular distance acuity. Financial Disclosure Drs. Whitman, Hovanesian, Steinert, and Koch received compensation for participating in the study from Revision Optics, Inc. Drs. Steinert and Koch are medical monitors for Revision Optics, Inc. None of the other authors has a financial or proprietary interest in any material or method mentioned.

Effect of Volatile Compounds on Excimer Laser Power Delivery

PURPOSE To determine whether vapors from perfume, hairspray, oil-based paint, or water-based paint affect excimer laser beam power delivery at the corneal surface. METHODS We measured the power delivery of an Apex Plus laser before, during, and after exposure to vapors from the following volatile compounds: three types of perfume, hair spray, an oil-based paint, and a water-based paint. A digital calorimeter was used to measure the steady-state beam power of the laser during laser discharge at the corneal plane. Multiple trials were run with each compound, and the change in laser energy over time was examined to determine if any of the compounds caused degradation of the laser optics. RESULTS The presence of a volatile compound in the room caused no change in mean laser energy in comparison to before and after the compound was present. However, perfumes caused a progressive decline in laser beam power throughout the trials. Controlling for this progressive decline, there was no significant difference from perfume to perfume. CONCLUSIONS None of the compounds tested caused a decline in laser beam power while present in the room. However, the presence of any perfume caused a deterioration in beam power over time, suggesting a degradation of the laser optics for all perfumes. Laser centers should consider advising their patients and staff to not wear perfumes in the laser suite.

Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease

Purpose: Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease. Methods: Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score ⩾1 and ⩽10 mm, eye dryness score ⩾40 (visual analog scale 0–100), corneal staining score ⩾2.0 (0–4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment-emergent adverse events and drop comfort scores were assessed. Results: Overall, 2464 participants (lifitegrast, n = 1287; placebo, n = 1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (> 5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8). Conclusion: Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.