Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial.

BACKGROUND: The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin® SF), for management of postoperative inflammation and pain, after cataract surgery. METHODS: This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intent-to-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). RESULTS: A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). CONCLUSION: The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.

Efficacy and safety of bromfenac 0.09% and sodium hyaluronate 0.4% combination therapy, versus placebo in patients with pterygium I-III for clinical signs on ocular inflammation.

Purpose: This study evaluated the clinical efficacy and safety of bromfenac 0.09%, sodium hyaluronate 0.4% (SH) combination therapy, versus placebo and SH in a clinical model of pterygium I-III. Methods: A total of 166 eyes (99 patients) with pterygium grade I-III were randomized to bromfenac 0.09% ophthalmic solution+SH 0.4% or placebo+SH 0.4%. This was a Phase IV, prospective, parallel, double-masked, multicenter clinical trial. One drop of bromfenac or placebo was instilled two times a day (BID) for 20 days, both groups accompanied treatments with one drop of SH three times a day (TID). The primary efficacy endpoints were the conjunctival hyperemia and the Ocular Surface Disease Index (OSDI) score. Other results measured included burning, foreign body sensation, and photophobia. The safety was assessed by the tear break-up time (TBUT), visual acuity (VA), IOP, lissamine green, fluorescein stains, and the incidence of adverse events (AEs). Results: Compared with baseline, there was a significant reduction in the conjunctival hyperemia (p=0.0001) and OSDI score in both groups (p=0.0001). There was a significant improvement in ocular symptomatology for both, placebo/SH and bromfenac/SH groups (p=0.0001), the decrement in the ocular burning was 41.1% vs 24.6%, the foreign body sensation was 31.5% vs 36.2% and, for photophobia was 23.3% vs 30.5%, respectively. A statistically significant difference was observed in TBUT for bromfenac/SH (p=0.045), at day 20. There were no significant alterations in IOP (p=0.068) or VA (p=0.632). Similar improvements were observed in the fluorescein and green lissamine staining. Finally, the incidence of AE was similar between groups. Conclusion: The treatment with bromfenac 0.09% ophthalmic solution and SH 0.4% combination therapy for 3 weeks reduced clinical signs, in patients with pterygium I-III. The results suggest that bromfenac 0.09% can improve the symptomatology, reduce the presentation of clinical signs associated with superficial ocular inflammation.

Objective and subjective results following implantation of the FineVision trifocal intraocular lens in Mexican patients.

PURPOSE: To evaluate objective and subjective results after bilateral implantation of a diffractive trifocal intraocular lens (IOL) in a Mexican population. METHODS: Prospective, interventional case series involved 15 cataract surgery patients who underwent bilateral implantation of the trifocal Micro F lens FineVision IOL (PhysIOL, Liège, Belgium). Objective analysis involved assessment of monocular uncorrected distance (UDVA), near (UNVA) at 30 and 40 cm, and intermediate visual acuity (UIVA) at 50, 60, and 70 cm, preoperatively, and at postoperative months 1, 3, and 6. Higher-order aberrations were assessed via aberrometry. Contrast sensitivity was determined via modulation transfer function. Subjective outcomes were assessed using the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25). RESULTS: At postoperative month 6, mean monocular UDVA was 0.06 ± 0.11 logMAR, and UNVA was 0.03 ± 0.04 logMAR at 30 cm and 0.05 ± 0.08 logMAR at 40 cm. Mean UIVA at 50, 60, and 70 cm was 0.12 ± 0.06, 0.13 ± 0.08, and 0.04 ± 0.08 logMAR, respectively. Spherical equivalent at postoperative month 3 was 0.23 ± 0.4 diopters (D). Aberrometry revealed a mean RMS of 0.18 microm and PSF of 0.19 (Strehl ratio). VFQ-25 questionnaire results showed a mean score of 93.64 ± 4.19 points (maximum 100 points). Vision during distance and near activities was reported as "excellent." Adverse events were reported as occurring "never to occasionally." CONCLUSION: Implantation of a diffractive trifocal IOL in a Mexican population appears safe and effective, both objectively and subjectively. Good uncorrected visual acuity outcomes were achieved at far, near, and intermediate distances. Overall patient satisfaction was excellent.

Management of traumatic cataract in adults at a reference center in Mexico City.

The purpose of the study was to determine the clinical presentation, mode of injury, surgical, and postoperative outcomes in adult patients with traumatic cataract. This is a clinical, observational, and retrospective study with review of records of patients in the period 2010-2012. Eighty patients were included, of whom 67 (83.75 %) were male. The mean age at presentation was 46 years (range 18-82 years). Sixty-four patients (80 %) had a closed-globe blunt ocular trauma and 16 (20 %) had an open-globe penetrating trauma. Seventy-seven (96.25 %) patients underwent phacoemulsification; 13.7 % (n = 11) required placement of capsular tension rings and 22.5 % (n = 18) automated anterior vitrectomy. In 53 % of the cases the intraocular lens (IOL) was placed in the capsular bag. Forty-seven patients (58.75 %) achieved a best-corrected visual acuity of 20/40 or better. In 57 (71.25 %) the final refraction was obtained, with a mean spherical equivalent of -0.56D (range -3.50D to +2.00 D). The improvement in visual acuity was significantly higher when the IOL was placed in the capsular bag compared to when it was placed in the sulcus (average difference of 0.667, p = 0.001). The most common mechanism of trauma is closed globe. Phacoemulsification was the procedure most common performed, with the IOL placed most commonly in the capsular bag. The final best-corrected visual acuity in most patients was 20/40 or better. Placing the IOL in the capsular bag represented an improvement in visual acuity compared to placement in the sulcus.

Anterior chamber bacterial contamination in cataract surgery.

BACKGROUND: The incidence of postoperative endophthalmitis has reduced during last several years to <0.01%; however, its associated complications continue to be devastating. Several sources of infection, including contamination by air, solutions, surgical instruments, intraocular lens, and wound leakage have been identified. The objective of this study was to evaluate the surgical technique, antibiotics, and asepsis that are used to reduce the risk of infection during cataract surgery. METHODS: This was a transversal prospective study, in which 64 cataract surgeries were evaluated from 32 patients, with 1 month recovery time; and cultures from preoperative and postoperative aspirates were analyzed. Two groups were established based on whether preoperative antibiotics were given or not. The analysis employed descriptive statistics. RESULTS: Of the 32 patients whose aspirates were obtained, three (9.37%) and 10 (31.25%) yielded positive cultures preoperative and postoperatively respectively. Staphylococcus species was the most common contaminating bacteria. The isolation of Staphylococcus species may indicate its potential as exogenous contaminant at time of wound closure. The cultures obtained from patients using preoperative antibiotics were positive for S. aureus in 10% (n = 2) of cases, and positive in 8.33% (n = 1) of cases not using antibiotics. The mean transoperative time with positive growth was 67 ± 17.8 minutes, and with negative growth was 76.3 ± 25.2 minutes. Two surgical techniques were evaluated: phacoemulsification and extracapsular extraction. The extracapsular technique showed a contamination rate of 33.33% (n = 8) compared to phacoemulsification with a rate of 25% (n = 2) (RR = 1.33). CONCLUSIONS: Common contaminating microorganisms included the Staphylococcus species, which was isolated from the eyelids and ocular annexes at the time of wound closure. The isolation of microorganisms postoperatively could have been influenced by the surgical technique used, the surgical time, and the use of antibiotics.

Four years old, one eye, pars planitis and cataract: surgical challenges give challenging surprises.

Pars planitis (PP) is an intermediate form of uveitis, which, if left untreated, can result in vision loss. Although phacoemulsification with IOL implantation in eyes with PP often results in improved vision, it represents a surgical challenge due to inflammatory sequelae and the possibility of postoperative complications. This case report describes a 4-year-old male who was admitted for poor visual acuity and severe photophobia. The patient previously received vitreo-retinal surgery on his right eye due to an 'unknown disease'. Ophthalmological evaluation revealed NLP, pupillary seclusion and band keratopathy in the right eye; echographic scans revealed funnel retinal detachment. The left eye had a visual acuity of CF at 1 foot, minimal band keratopathy, posterior synechiae and the following echographic findings: abundant vitreous opacities and increased chorioretinal thickness (1.6 mm). Complete medical and laboratory assessments found no infectious pathologies. The patient was diagnosed with PP. Anti-inflammatory and immunological therapy was given in order to control inflammation. Within four months, the inflammation was controlled. Slow motion phacoemulsification with iris-retractors was performed. During the surgery, an unexpected challenge was identified: an opaque-vascular retrolental membrane. The membrane was cauterized with diathermy. Primary posterior capsulotomy and membranectomy were performed, followed by a limited anterior vitrectomy. An in-the-bag IOL was implanted successfully, with no postoperative complications, and visual acuity improved to 20/200.

Surgical management and scheimpflug analysis of an atypical lens coloboma.

A lens coloboma is not a true coloboma; it is just a zonular absence that causes a defect in the lens equator and hence a more spherical lens. It can be isolated or in association with iris, choroid or retinal colobomas. Typically the defect is present at the site of the embryonic fissure, but it can be present elsewhere. This congenital defect can cause amblyopia, especially when it is associated with cataract. We describe a case of a 39-year-old male with an atypical coloboma that was managed successfully with phacoemulsification, capsular tension ring and intraocular lens implantation. Scheimpflug image analysis and full ophthalmological assessment were performed. Scheimpflug images demonstrated a notching of the lens equator and an absence of zonulae. During the surgical procedure an ophthalmic viscosurgical device was used to tamponade the vitreous, and after continuous curvilinear capsulorhexis the capsular tension ring was inserted to allow the surgeon to perform a safe phacoemulsification.

Intraocular lens iris fixation. Clinical and macular OCT outcomes.

BACKGROUND: To assess the efficacy, clinical outcomes, visual acuity (VA), incidence of adverse effects, and complications of peripheral iris fixation of 3-piece acrylic IOLs in eyes lacking capsular support. Thirteen patients who underwent implantation and peripheral iris fixation of a 3-piece foldable acrylic PC IOL for aphakia in the absence of capsular support were followed after surgery. Clinical outcomes and macular SD-OCT (Cirrus OCT; Carl Zeiss Meditec, Germany) were analyzed. FINDINGS: The final CDVA was 20/40 or better in 8 eyes (62%), 20/60 or better in 12 eyes (92%), and one case of 20/80 due to corneal astigmatism and mild persistent edema. No intraoperative complications were reported. There were seven cases of medically controlled ocular hypertension after surgery due to the presence of viscoelastic in the AC. There were no cases of cystoid macular edema, chronic iridocyclitis, IOL subluxation, pigment dispersion, or glaucoma. Macular edema did not develop in any case by means of SD-OCT. CONCLUSIONS: We think that this technique for iris suture fixation provides safe and effective results. Patients had substantial improvements in UDVA and CDVA. This surgical strategy may be individualized however; age, cornea status, angle structures, iris anatomy, and glaucoma are important considerations in selecting candidates for an appropriate IOL fixation method.

Ultrabiomicroscopic-histopathologic correlations in individuals with autosomal dominant congenital microcoria: three-generation family report.

BACKGROUND: Congenital microcoria (CMC) is due to a maldevelopment of the dilator pupillae muscle of the iris, with a pupil diameter of less than 2 mm. It is associated with juvenile open angle glaucoma and myopia. We report on a three-generation Mexican-Mestizo family with CMC. The eldest member's iris biopsy proved muscle anomalies. Further, we analyzed novel ultrasound biomicroscopy findings in the family members who did not require surgery. PATIENTS AND METHODS: A 62-year-old woman, her 41-year-old son and her 9-year-old grandson affected with microcoria since birth, documented by clinical examination and ultrasound biomicroscopy. The eldest member underwent phacoemulsification, and a biopsy of the iris and the anterior capsule of the lens was taken. RESULTS: Ultrasound biomicroscopy confirmed the CMC diagnosis showing iris thinning and a pupil diameter of less than 2 mm. Histopathology of the iris showed a significant reduction of smooth muscle cells, but no alterations of the anterior lens capsule. DISCUSSION: Although CMC is a rare disorder, which is due to a maldevelopment of the dilator pupillae muscle of the iris, it could be associated with juvenile open angle glaucoma and myopia; therefore, precise diagnosis is required. Ultrasound biomicroscopy could be a great option to confirm the disorder.

Sensibilidad al contraste postfacoemulsificación e implante de lente intraocular / Contrast sensitivity after phacoemulsification and intraocular lens implant

Objetivo: Conocer si existe alteración en la sensibilidad al contraste en pacientes operados de catarata mediante facoemulsificación e implante de distintos tipo de lentes intraoculares (LIO). Método: Se realizó un estudio prospectivo para evaluar la sensibilidad al contraste posterior a facoemulsificación e implante de LIO. Al tercer mes postoperatorio se evaluó la sensibilidad al contraste con la cartilla Vistech 6500 en 45 pacientes que presentaban en ese momento agudeza visual con su mejor corrección de 20/30 o mejor. Dependiendo del tipo de LIO, se dividió a los pacientes en tres grupos de estudio: Grupo 1) LIO monofocal de polimetilmetacrilato (PMMA) con 22 pacientes, Grupo 2) LIO flexible de silicón (Silicon) con 14 pacientes y Grupo 3) LIO multifocal de PMMA (Multifocal) con 9 pacientes. Cincuenta pacientes fáquicos sin ninguna patología oftálmica fueron incluidos como grupo control. Resultados: Se encontró una disminución de la sensibilidad al contraste estadísticamente significativa en los grupos estudiados al compararlos con el grupo control (p<0.01). Aunque entre los tres grupos estudiados no hubo diferencia estadística significativa, el grupo de silicón resultó ser el de la sensibilidad al contraste más disminuida. Conclusión: Observamos que aunque los pacientes tengan buena visión postoperatoria con facoemulsificación e implante de LIO, la sensibilidad al contraste está disminuida pudiéndose modificar la agudeza visual cualitativa.