Dexamethasone intravitreal implants (0.7 mg and 0.35 mg) met the primary endpoint for improvement in best-corrected visual acuity in two randomized, multicenter, masked and sham-controlled clinical trials in patients with diabetic macular edema. Additionally, the safety profile was acceptable and consistent with previous reports.
Patients (n=1,048) with DME, a BCVA of 20/50 to 20/200 Snellen equivalent and central retinal thickness of ≥300 μm by optical coherence tomography were randomized into a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg or sham procedure and followed for three years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every six months. The predefined primary efficacy endpoint for the U.S. Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures include adverse events and intraocular pressure.
Mean number of treatments received over three years was 4.1, 4.4 and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg and sham, respectively. The percentage of patients with ≥15-letter improvement was greater with DEX implant 0.7 mg (22.2 percent) and DEX implant 0.35 mg (18.4 percent) than sham (12 percent; p≤0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 μm) and DEX implant 0.35 mg (-107.9 μm) than sham (-41.9 μm; p<0.001). Rates of cataract-related adverse events in phakic eyes were 67.9 percent in the DEX implant 0.7-mg group; 64.1 percent in the DEX implant 0.35-mg group; and 20.4 percent in the sham group. Increases in IOP were usually controlled with medication or no therapy; only two patients (0.6 percent) in the DEX implant 0.7-mg group and one patient (0.3 percent) in the DEX implant 0.35-mg group required trabeculectomy.
Ophthalmology 2014;121:1904-1914.
This is an open access article.
Boyer D, Yoo Y, Belfort R, Bandello F, et al.
Topical NSAIDs Beneficial After Routine Cataract Surgery
Researchers in Denmark conducting a systematic literature review found high-quality evidence that topical non-steroidal anti-inflammatory drugs are more effective than topical steroids in preventing pseudophakic cystoid macular edema. The researchers also found low to moderate quality evidence that topical NSAIDs are more effective than steroids in controlling postoperative inflammation after cataract surgery.
The researchers conducted a literature search in Medline, CINAHL, Cochrane and EMBASE databases to identify randomized trials published from 1996 onward comparing steroids with topical NSAIDs in controlling inflammation and preventing PCME in patients undergoing phacoemulsification with posterior chamber intraocular lens implantation for age-related cataract. Fifteen randomized trials were identified. Postoperative inflammation was less in patients randomized to NSAIDs. The prevalence of PCME was significantly higher in the steroid group than in the NSAID group: 3.8 percent vs. 25.3 percent of patients (r: 5.35; 95 percent confidence interval, 2.94 to 9.76).
Ophthalmology 2014;121:1915-1924.
Kessel L, Tendal B, Jørgensen K, Erngaard D, et al.
A Novel Drug Coating for Glaucoma Drainage Devices
Researchers from Tulane have developed a novel, porous coating for Ahmed glaucoma valves based on biodegradable poly(lactic-co-glycolic acid), which allows for the combined use of both mitomycin-C and 5-fluorouracil to inhibit cell proliferation in a tissue culture model. This has the potential to reduce fibrosis and increase the success rate for glaucoma drainage devices.
Thin films of PLGA were fabricated using a spin-coating technique. The procedure led to an asymmetric pore structure that was exploited to control the rate of dissolution. Double-layered porous films were constructed to achieve continuous drug release, providing a burst release of mitomycin-C followed by a slow release of 5-FU, which together prevented fibrosis over the most active period of postoperative wound healing (zero to 28 days). Double-layered films containing only 5-FU in the bottom layer showed a three to five day delay in drug release, followed by a sharp increase that continued for 28 days. Mitomycin-C was only stable when it was surface-loaded; it was therefore surface-loaded onto the top PLGA layer to provide a continuous release of antifibrotics over the wound-healing period.
J Glaucoma 2014;23:526-534.
Ponnusamy T, Yu H, Jon V, Ayyala R, et al.
Safety and Efficacy of PRK: 20-year Follow-up
Researchers from the Keratoconus Research Institute in London found, in a 20-year observational study investigating the safety and efficacy of photorefractive keratectomy, that there was a slight but significant increase in myopic spherical equivalent refractive error after PRK between one and 20 years, particularly in those under 40 at the time of treatment and in female patients. Corneal power remained unchanged but axial length increased. Overall, the procedure was safe, with no long-term, sight-threatening complications and with improvements in corrected distance visual acuity and corneal transparency with time.
In the setting of a university hospital, a study population of 42 patients (42 eyes) who had, as part of a randomized, prospective trial, undergone PRK 20 years previously were studied. All had received either -3 D or -6 D corrections with either 5 or 6 mm optical zones or a multizone treatment. The mean preoperative SEQ was -5.13 D (r: -2.75 to -8 D). The outcome measures included visual acuity, refractive error, corneal topography and axial length.
Between one and 20 years there was an increase in mean myopic SEQ of -0.54 D (p<0.02). In patients younger than 40 years of age at the time of correction, this increase was -0.92 D (p<0.002) with an accompanying increase in variance (p<0.02), whereas in those older than 40 it was -0.08 D (p=0.8). In female patients the change was -0.69 D (p<0.01), while in males it was -0.26 D (p=0.6). The efficacy index at 20 years was 0.49 and the safety index was 0.97. Corrected distance visual acuity improved between one and 20 years (p<0.01); 93 percent of corneas were clear at 20 years; three eyes had trace haze. There was an improvement in haze scores between one and 20 years (p<0.02). Cornea power remained unchanged between six months and 20 years (p=0.4). Axial length increased by a mean of 0.84 (p<0.0001), and there was no ectasia.
Am J Ophthalmol 2014;158:651-663.
O’Brart D, Shalchi Z, McDonald R, Patel P, et al.
Evaluating Presbyopia-Correcting IOLs After Bilateral Implants
In a clinical trial comparing contrast sensitivity, visual acuity and halos in subjects bilaterally implanted with one of three FDA-approved presbyopia-correcting intraocular lenses, the Crystalens AO (Bausch + Lomb Surgical) had statistically better uncorrected intermediate visual acuity and distance-corrected intermediate visual acuity than the AcrySof IQ ReSTOR +3.0 (Alcon Laboratories) or Tecnis Multifocal (Abbott Medical Optics) lenses. The Crystalens AO also had fewer photic phenomenon than the Tecnis Multifocal lens. However, both the ReSTOR +3.0 and the Tecnis Multifocal lenses had better distance-corrected near visual acuity and uncorrected near visual acuity than the Crystalens AO.
Subjects (n=78) were randomized sequentially in a partially masked, multicenter trial for bilateral implantation with the Crystalens AO, ReSTOR +3.0 or Tecnis Multifocal lenses. Subjects were evaluated through visit four (four to six months after surgery) with the following monocular and binocular assessments: high- and low-contrast visual acuity; contrast sensitivity without glare, halos or starbursts; defocus curves; optical scatter; retinal point spread function; and safety.
The Crystalens AO and ReSTOR +3.0 demonstrated better monocular and binocular contrast sensitivity without glare at low to mid spatial frequencies compared with the Tecnis Multifocal lens. Binocular uncorrected distance visual acuity was not significantly different between the lenses. The Crystalens AO had significantly better binocular low-contrast distance-corrected visual acuity than the ReSTOR +3.0 and better mean monocular low-contrast DCVA than the Tecnis Multifocal lens. The Crystalens AO demonstrated significantly better monocular and binocular uncorrected and distance-corrected intermediate visual acuity than the ReSTOR +3.0 or Tecnis Multifocal lens. The ReSTOR +3.0 lens had significantly better monocular and binocular uncorrected and distance-corrected near visual acuity tested at 40 cm compared with the Crystalens AO and the Tecnis Multifocal lens. The Crystalens AO elicited significantly less occurrence of halos than the Tecnis Multifocal lens and less optical scatter than either the ReSTOR +3.0 or Tecnis Multifocal lens.
Am J Ophthalmol 2014;158:436-446.
Pepose J, Qazi M, Chu R, Stahl J.
