To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress (WC) for adults with meibomian gland dysfunction (MGD).
This was a non-significant risk, ...prospective, open-label, randomized, crossover multicenter clinical trial. One hundred thirty-nine subjects were randomized between LipiFlow (n=69) and WC control (n=70). Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day, 2 weeks and 4 weeks. Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks. At 2 weeks, they crossed over (LipiFlow Crossover) and received the LipiFlow treatment. Effectiveness parameters: meibomian gland (MG) assessment, tear break-up time (TBUT) and dry eye symptoms. Safety parameters: adverse events, ocular health exam, ocular surface staining, intraocular pressure, visual acuity and discomfort.
LipiFlow resulted in significant improvement (P < 0.05) in MG secretion at 2 and 4 weeks (mean ± standard deviation at baseline = 6.3 ± 3.5; 2 weeks = 14.3 ± 8.7; 4 weeks = 16.7 ± 8.7); and TBUT at 2 and 4 weeks: (at baseline = 5.5 ± 2.9; 2 weeks = 6.9 ± 5.0; 4 weeks = 7.4 ± 5.5). There was no significant change in MG secretion or TBUT in the control group. LipiFlow resulted in a greater significant reduction in dry eye symptoms than the iHeat WC. The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow. There was no significant difference between groups in the incidence of non-serious, device-related adverse events.
The LipiFlow System was significantly more effective than iHeat WC. These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms.
Corneal ectasia is a progressive, degenerative, and noninflammatory thinning disorder of the cornea. Recently developed corneal reshaping techniques have expanded the treatment armamentarium ...available to the corneal specialist by offering effective nontransplant options. This review summarizes the current evidence base for corneal collagen crosslinking, topography-guided photorefractive keratectomy, and intrastromal corneal ring segment implantation for the treatment of corneal ectasia by analyzing the data published between the years 2000 and 2014.
No author has a financial or proprietary interest in any material or method mentioned.
The cornea is unique because of its complete avascularity. Corneal neovascularization (CNV) can result from a variety of etiologies including contact lens wear; corneal infections; and ocular surface ...diseases due to inflammation, chemical injury, and limbal stem cell deficiency. Management is focused primarily on the etiology and pathophysiology causing the CNV and involves medical and surgical options. Because inflammation is a key factor in the pathophysiology of CNV, corticosteroids and other anti-inflammatory medications remain the mainstay of treatment. Anti-VEGF therapies are gaining popularity to prevent CNV in a number of etiologies. Surgical options including vessel occlusion and ocular surface reconstruction are other options depending on etiology and response to medical therapy. Future therapies should provide more effective treatment options for the management of CNV.
To determine the incidence, clinical features, and outcomes of infectious keratitis after Boston type 1 keratoprosthesis (Kpro) implantation.
Ten cases of infectious keratitis were identified in a ...retrospective chart review of 105 patients (126 eyes) who received Kpro between November 2004 and November 2010 at the Cincinnati Eye Institute and were followed for at least 1 month (range, 1-66 months; mean, 25 months).
The incidence was 7.9%. Patient diagnoses included 4 chemical injuries, 3 Stevens-Johnson syndrome, 2 ocular cicatricial pemphigoid, and 1 congenital aniridia. Kpro implantation was indicated in 2 eyes for a failed ocular surface and in 8 for penetrating keratoplasty failure. Four patients were contact lens intolerant or noncompliant. All were on topical vancomycin and moxifloxacin for prophylaxis and 2 were on topical amphotericin for prophylaxis. Three infiltrates were culture negative, 5 were fungal (3 Candida, 1 Fusarium, 1 Dactylaria constricta), and 2 were bacterial (Rhodococcus equi and Gram-negative cocci). All patients were managed with topical agents and 4 were given an oral antifungal agent. Four patients had Kpro removal with therapeutic penetrating keratoplasty and 1 had Kpro replacement. At final follow-up, only 2 patients retained their preinfection best vision. Risk factors for infectious keratitis included a diagnosis of cicatrizing conjunctivitis (Stevens-Johnson syndrome, ocular cicatricial pemphigoid, or chemical injury) and a history of persistent epithelial defect (P = 0.0003 and 0.0142, respectively). Contact lens wear, vancomycin use, and a history of systemic immunosuppression (or use at the time of infection) were not statistically significant risk factors.
Infectious keratitis after Kpro can occur even when patients are on vancomycin and a fourth-generation fluoroquinolone for prophylaxis. Fungal organisms are a growing cause for concern, and we present the details of the first reported case of ocular D. constricta. The evolution of our management and prophylaxis strategy for fungal keratitis after Kpro implantation is also described.
To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein ...corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD.
This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks.
One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002).
Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.
To investigate the long-term outcomes of ocular surface stem cell allograft transplantation (OSST) in patients with total limbal stem cell deficiency (LSCD) owing to various etiologies with a ...follow-up ≥ 5 years.
Retrospective interventional cohort.
Setting: Single tertiary referral hospital. Study Population: Patients who had (1) presence of total LSCD, (2) surgical treatment with at least 1 allograft OSST procedure, and (3) minimum follow-up ≥ 5 years after OSST. Intervention: All patients underwent allograft OSST from March 1998 to June 2009. All patients received systemic immunosuppression. Main Outcome Measures: Ocular surface stability, best-corrected visual acuity (BCVA).
A total of 165 eyes of 110 patients fulfilled the inclusion criteria with a mean follow-up period of 109.22 ± 35.7 months or approximately 9.1 years (range 5.2–17.7 years). Ocular surface stability was achieved in 72.7% (120/165) of eyes at last follow-up, while 15.2% (25/165) maintained an improved ocular surface and 12.1% (20/165) developed total surface failure. Additional OSST surgery was necessary in 30.9% (51/165 eyes) to maintain a stable ocular surface. There was ≥ 2 lines BCVA improvement in 62.1%, no change in 7.7%, and a worsened BCVA in 18.6% at last follow-up.
With proper immunosuppression and repeat procedure in case of failure, allograft OSST can provide true long-term ocular surface stability and successful visual outcomes.
An investigation of the treatment effect of lifitegrast ophthalmic solution, 5.0%, in different subgroups by severity of dry eye disease (DED) seems warranted.
To explore the heterogeneity across ...different subgroups of DED and identify which participants were most likely to achieve clinically meaningful benefit with lifitegrast treatment.
This post hoc responder analysis was performed using the data from the phase 3 OPUS-2 and OPUS-3 studies, which were 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials that previously demonstrated the efficacy of lifitegrast in DED. Pooled data were stratified into 4 subgroups based on severity of inferior corneal staining score (ICSS; ≤1.5 vs >1.5) and eye dryness score (EDS; <60 or ≥60) at baseline. Data were collected from December 7, 2012, to October 5, 2015, and post hoc analysis was performed from April 14, 2020, to July 30, 2021.
Lifitegrast or placebo twice daily for 84 days.
Proportion of participants with (1) a clinically meaningful improvement in signs (ICSS or total corneal staining score TCSS) and symptoms (EDS or global visual analog scale VAS) and (2) a composite response for a given sign and symptom end point pair at day 84 were measured. Clinically meaningful improvement was defined as at least 30% improvement in symptoms (EDS or global VAS) and either at least a 1-point improvement in ICSS or at least a 3-point improvement in TCSS. For the composite responder analysis, the end point pairs were defined as at least a 30% reduction in EDS and at least a 1-point improvement in ICSS; at least a 30% reduction in EDS and at least a 3-point improvement in TCSS; at least a 30% improvement in global VAS and at least a 1-point improvement in ICSS; and at least a 30% improvement in global VAS and at least a 3-point improvement in TCSS.
In total, 1429 participants (716 in the placebo group and 713 in the lifitegrast group) were analyzed (1087 women 76.1%; mean SD age, 58.7 14.3 years). For the overall pooled population, responder and composite responder rates favored lifitegrast vs placebo (odds ratio range, 1.29 95% CI, 1.05-1.59 to 2.10 95% CI, 1.68-2.61; P ≤ .02). In the composite analysis, the subgroup with ICSS of greater than 1.5 and EDS of at least 60 at baseline (ie, moderate to severe DED) demonstrated a 1.70- to 2.11-fold higher odds of achieving clinically meaningful improvement with lifitegrast across all sign and symptom end point pairs (P ≤ .001).
These post hoc findings suggest that lifitegrast ophthalmic solution, 5.0%, treatment may be associated with a response in participants with moderate to severe signs and symptoms of DED.
ClinicalTrials.gov Identifier: NCT02284516.
To investigate the incidence of limbal stem cell deficiency (LSCD) in donor eyes after conjunctival limbal autograft (CLAU).
An observational retrospective review was performed on all patients who ...underwent CLAU alone, combined keratolimbal allograft with CLAU ("Modified Cincinnati Procedure"), or combined living-related conjunctival limbal allograft (lr-CLAL) with CLAU having ≥6 months of follow-up after surgery. The outcome measures were best-corrected visual acuity (BCVA) and ocular surface status.
The inclusion criteria were fulfilled by 45 patients. Of these, 26 patients underwent CLAU, 18 underwent combined keratolimbal allograft/CLAU, and 1 underwent combined lr-CLAL/CLAU. Mean age at the time of surgery was 39.6 years. Mean logMAR preoperative BCVA was -0.08. There were no operative complications. The mean follow-up duration after surgery was 48.3 months (range 8.3-181.5 mo). At last follow-up, all eyes maintained a stable ocular surface, and mean logMAR BCVA was -0.05.
With the advent of newer ocular surface transplantation methods, there has been concern that CLAU carries the theoretical risk of inducing LSCD. Our long-term clinical results following donor eyes after CLAU demonstrate no signs of LSCD.
The aim of this study was to characterize a large cohort of patients presenting to a single referral center for limbal stem cell deficiency (LSCD).
A retrospective chart review of all patients with a ...clinical diagnosis of LSCD from 2002 to 2015 was performed. Demographics, etiology, previous ocular surgeries, visual acuity, and treatment were assessed.
Seven hundred thirty-eight eyes of 434 patients (51.4% male subjects) were diagnosed with LSCD. The mean presenting age was 42.9 years, 70% presented with bilateral disease, and overall vision was poor. The most common etiologies were congenital aniridia (30.9%), chemical or thermal injuries (20.6%), contact lens (16.8%), Stevens-Johnson syndrome (SJS, 10.4%), and iatrogenic (7.3%). Congenital aniridia had a significantly increased association with glaucoma or ocular hypertension (P < 0.0001). Chemical or thermal injuries (P = 0.0007), SJS (P < 0.0001), and mucous membrane pemphigoid (P < 0.0001) had a significantly increased association with eyelid pathology. The mean logMAR best corrected visual acuity (analysis excluded eyes with light perception and no light perception) at presentation was 1.145 (∼20/280). Keratoplasty performed (before presentation at our center) without first addressing the LSCD was seen in 80 eyes; all keratoplasties failed due to recurrence of the LSCD.
Patients presenting with LSCD were on average middle aged without sex predominance. LSCD was most commonly bilateral, comprised a wide range of etiologies, and decreased vision substantially. Ocular comorbidities may need to be treated before treating the LSCD surgically. Finally, not addressing the LSCD (primary issue) first can result in keratoplasty failure.
To evaluate the safety and efficacy of a nepafenac punctal plug delivery system (N-PPDS) after cataract surgery.
Three U.S. clinical sites.
Prospective, multicenter, randomized (2:1), parallel-arm, ...double-masked, placebo-controlled, phase II pilot study.
Fifty-six subjects (aged older than 22 years) with expected postcataract correctable distance vision of 20/30 or better and lower puncta allowing dilation up to 1.0 mm received either the nepafenac (N-PPDS group; n = 38 eyes) or a placebo punctal plug delivery system (p-PPDS group; n = 18 eyes). All eyes underwent routine unilateral cataract surgery with intraocular lens implantation. The primary and secondary efficacy measures were postoperative ocular pain and inflammation, respectively.
There were 38 patients in the experimental N-PPDS group and 18 patients in the control group. The N-PPDS group had a significantly higher percentage of pain-free patients than that in the p-PPDS group (22/32 69% vs 6/16 38% at 3 days, P = .038; and 24/36 67% vs 5/16 31% at 7 days, P = .018). A higher percentage of patients in the N-PPDS group (15/29 52% vs 0/14 0% in p-PPDS) was pain free at all visits (P = .001). Anterior chamber cell scores were better in the N-PPDS group (patients with no anterior chamber cells: 18/36 50% vs 3/16 19% in p-PPDS; P = .034) at 7 days. The plug retention rate was 98% (55/56) at 14 days. Adverse events having a suspected relationship with the punctal plug treatment occurred in 1 case of the N-PPDS group having to do with placement and zero in the p-PPDS group.
The N-PPDS was safe and effective for the management of ocular pain and inflammation after cataract surgery.
PDF
