To assess the efficacy and safety of intravitreal inserts releasing 0.2 μg/day (low dose) or 0.5 μg/day (high dose) fluocinolone acetonide (FA) in patients with diabetic macular edema (DME).
Two ...parallel, prospective, randomized, sham injection-controlled, double-masked, multicenter clinical trials.
Subjects with persistent DME despite at least 1 macular laser treatment were randomized 1:2:2 to sham injection (n = 185), low-dose insert (n = 375), or high-dose insert (n = 393).
Subjects received study drug or sham injection at baseline and after 6 weeks were eligible for rescue laser. Based on retreatment criteria, additional study drug or sham injections could be given after 1 year.
The primary outcome was the percentage of patients with improvement from baseline best-corrected visual acuity (BCVA) in Early Treatment Diabetic Retinopathy Trial (ETDRS) letter score of 15 or more at month 24. Secondary outcomes included other parameters of visual function and foveal thickness (FTH).
The percentage of patients with improvement from baseline ETDRS letter score of 15 or more at month 24 was 28.7 and 28.6 in the low- and high-dose insert groups, respectively, compared with 16.2 in the sham group (P = 0.002 for each). Benefit occurred for both doses compared with sham at 3 weeks and all subsequent time points. The mean improvement in BCVA letter score between baseline and month 24 was 4.4 and 5.4 in the low- and high-dose groups, respectively, compared with 1.7 in the sham group (P = 0.02 and P = 0.016). At all time points compared with sham, there was significantly more improvement in FTH. Subjects requiring cataract surgery were more frequent in the insert groups, and their visual benefit was similar to that of subjects who were pseudophakic at baseline. Glaucoma requiring incisional surgery occurred in 3.7%, 7.6%, and 0.5% of the low-dose, high-dose, and sham groups, respectively.
Both low- and high-dose FA inserts significantly improved BCVA in patients with DME over 2 years, and the risk-to-benefit ratio was superior for the low-dose insert. This is the first pharmacologic treatment that can be administered by an outpatient injection to provide substantial benefit in patients with DME for at least 2 years.
To evaluate the efficacy of topical mitomycin C in treating conjunctival and corneal epithelial dysplasia and neoplasia.
Seven eyes of seven patients with conjunctival and corneal epithelial ...dysplasia and neoplasia were treated with one drop of topical mitomycin C 0.04% four times a day for 7 days in alternate weeks. The patients' charts were reviewed retrospectively. Patients with either multiple recurrences or extensive ocular surface involvement were treated. In all eyes, the diagnosis of epithelial dysplasia or neoplasia was confirmed by histopathology before the onset of therapy. Patients were examined at least every 14 days during treatment and examined at intervals after completion of treatment.
With topical mitomycin C, six eyes of seven patients had complete clinical regression of their conjunctival and corneal epithelial dysplasia and neoplasia. One eye of one patient had partial clinical regression of conjunctival and corneal epithelial dysplasia. Follow-up after completion of topical mitomycin C therapy and excision of residual disease ranged from 2 to 16 months (mean, 9 months; SD, 4.3 months) and was without clinical sign of recurrence. Topical mitomycin C therapy was associated with transitory ocular discomfort, conjunctival injection, tearing, photophobia, and punctate epithelial keratopathy.
In this small series of eyes, topical mitomycin C was effective as a treatment for conjunctival and corneal epithelial dysplasia and neoplasia.
Abstract A case of posttraumatic loss of vision was seen in the emergency department that was diagnosed as Purtscher's retinopathy or traumatic retinal angiopathy. Purtscher's retinopathy presents as ...an acute loss of vision after a traumatic event or as a sequelae of another disease process. The case is presented with a discussion of the pathophysiology, diagnosis, prognosis, and treatment options for this entity.
This is a preliminary report to describe our technique of office-based vitrectomy (OVIT) and to report the incidence of complications over a 6-year period.
In a retrospective, noncomparative case ...series, OVIT was performed on 225 patients in four participating offices. Each patient was operated on with a 23-gauge vitreous cutter that the authors have developed. They have also developed a 23-gauge transconjunctival infusion needle device. Diagnoses included endophthalmitis, uveitis, intravitreal lens fragments, ghost cell glaucoma, and rhegmatogenous retinal detachment.
The surgical goal was accomplished in all cases, but supplemental office procedures were required for two eyes, and a scleral buckle was necessary in one eye. There were 15 complications in 14 eyes: "fish-egg" gas bubbles (one eye), intraocular hemorrhage (nine eyes), choroidal detachment (two eyes), new retinal breaks (one eye), retinal detachment (one eye), and temporary elevation of intraocular pressure (one eye). The hemorrhages, choroidal detachments, and fish-egg bubbles all resolved spontaneously.
Office-based sutureless transconjunctival pars plana vitrectomy, with infusion when needed, is an effective operation for selected diseases of the posterior segment. In a multicenter series of 225 eyes, there were 15 complications in 14 (6%) eyes. Two of the complications were successfully managed with additional office procedures; one was managed in the operating room; and 12 resolved spontaneously.
OBJECTIVE To describe a new treatment for vision loss caused by subretinal fluid associated with circumscribed choroidal hemangioma. METHODS Three patients were treated with photodynamic therapy ...using verteporfin for injection (Visudyne; QLT Phototherapeutics Inc, Vancouver, British Columbia). All patients had pretreatment and posttreatment fluorescein angiography and ultrasonography. Treatment parameters used were verteporfin, 6 mg/m2, and laser light at 689 nm delivered at 50 J/cm2 with an intensity of 600 mW/cm2 for 83 seconds. RESULTS All patients had complete resolution of subretinal fluid within 2 weeks of treatment. Fluorescein angiography performed 2 to 4 weeks after treatment showed absence of tumor leakage. All eyes had reduced tumor thickness or complete flattening. Visual acuity was improved in each eye. Average follow-up was 5.3 months. No complications were noted. CONCLUSION Photodynamic therapy with verteporfin is effective in eliminating subretinal fluid and improving vision in patients with circumscribed choroidal hemangioma.Arch Ophthalmol.2001;119:1606-1610-->
To study the histopathology of a stage III macular hole that had been treated by vitrectomy with cortical vitreous and epicortical vitreous membrane peeling and gas tamponade.
The light and electron ...microscopic features of a treated macular hole were studied.
A 16-microns-wide break was present in the external limiting membrane. This was sealed by Müller cell processes. Photoreceptors adjacent to the healed defect appeared normal. No cystoid macular edema was present.
Cortical vitreous peeling and gas tamponade can allow the macular hole to settle and the edges to re-approximate. The residual defect can be sealed by Müller cells.
Varicella-zoster virus (VZV) causes ocular and other central nervous system (CNS) disease in human immunodeficiency virus (HIV)-infected persons. To study the prevalence of CNS disease due to VZV, ...cerebrospinal fluid (CSF) specimens from 84 consecutive HIV-infected patients with new neurologic symptoms were tested for VZV DNA by a polymerase chain reaction (PCR) assay. Six patients were PCR-positive for VZV in CSF; 3 additional patients were subsequently identified who were not part of the serial population sample. Among these 9 patients, all had clinical presentations consistent with ocular and other CNS disease due to VZV; 4 were without zoster on presentation. Sustained improvement in association with antiviral therapy was observed in 3. Therefore, VZV DNA was detected in the CSF of 7% of HIV-infected patients presenting with neurologic symptoms; the diagnosis of VZV-related CNS disease was facilitated by this assay; improvement in association with antiviral therapy was observed in some patients.
To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME).
Secondary analysis of a ...36-month, phase IV, nonrandomized, open-label, observational study.
The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication.
Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant.
Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan–Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable.
Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To evaluate effects of the 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (ILUVIEN) on intraocular pressure (IOP) in patients with diabetic macular edema (DME).
Secondary analysis of a ...36-month, phase IV, nonrandomized, open-label, observational study.
The study included 202 eyes from 159 patients who received the 0.19-mg FAc implant after a successful prior steroid challenge per the United States label indication.
Study eyes were assessed for IOP values, incidence of IOP elevations, and best-corrected visual acuity (BCVA) for up to 36 months post-FAc implant.
Mean IOP was stable over 36 months post-FAc; IOP change from baseline peaked at 2.12 mmHg at 9 months, then declined to baseline levels. At 36 months, eyes had a 32.5% cumulative probability of an IOP event > 25 mmHg and a 15.6% probability of an IOP event > 30 mmHg (Kaplan-Meier). The probability of requiring IOP-lowering medication at any time by month 36 was 38.3%. A total of 78% of eyes did not have IOP elevations > 25 mmHg if similar values were seen with the previous steroid challenge. Although 7.4% of eyes had an IOP > 30 mmHg during a scheduled study visit, most exceeded this threshold only once (60%). Regardless of IOP status, mean BCVA remained stable.
Over 36 months, the 0.19-mg FAc implant was associated with relatively stable IOPs in patients with DME, and there was no significant impact of IOP elevations identified regarding their effects on long-term visual outcomes. The probability that a prior corticosteroid challenge will not predict an IOP elevation > 25 mmHg over 36 months post-FAc is 22%; therefore, routine IOP monitoring should be scheduled.
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
To determine the ultrastructural characteristics of the operculum associated with macular holes.
We developed instrumentation and a technique to capture the operculum observed with macular holes. Two ...opercula were studied by transmission electron microscopy.
The two specimens were attached to a layer of native collagen identified as cortical vitreous and were composed primarily of Mueller cells and fibrous astrocytes without adjacent inner limiting membrane. No distinct retinal neuronal tissue was present.
Our findings indicate that proliferation of fibrous astrocytes and Mueller cells occurs with the formation of a macular hole, that this reparative tissue may be dislodged, and it is the reparative tissue that previously has been interpreted as an operculum.
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