In a study comparing the accommodation-restoration properties of accommodating and monofocal intraocular lenses, no clear evidence of near acuity improvement was found, despite statistically significant pilocarpine-induced anterior lens displacement. The authors of the study, which took place at
The meta-analysis comprised 12 randomized controlled studies of 727 eyes. Based on 10 studies that compared DCNVA, accommodating IOLs were favored but failed the test of heterogeneity (I2=94 percent). Pooling the six homogeneous trials (I2=43 percent) showed no difference (standardized mean difference, -0.16; 95 percent CI, -0.56 to 0.25). Heterogeneity could not be explained by any characteristic of the study population or methodology. Based on four studies that evaluated pilocarpine-induced IOL shift, there was a significant anterior shift compared with the control (weighted mean difference, 95 percent CI, -0.36, -0.47 to -0.24), although the studies were heterogeneous (I2=58 percent). Three of five studies mentioning posterior capsule opacification reported increased rates in the accommodating IOL group postoperatively. The study's authors conclude that further randomized controlled studies with standardized methods evaluating adverse effects (e.g., PCO) are needed to clarify the trade-offs.
J Cataract Refract Surg 2010;36:380-8
Takakura A, Iyer P, Adams JR, Pepin SM
DSAEK and PK Yield Similar One-Year, Post-Transplantation Results
One-year post-transplantation, overall graft success was comparable for Descemet's stripping automated endothelial keratoplasty and penetrating keratoplasty procedures, and endothelial cell loss was higher with DSAEK, according to researchers behind the Specular Microscopy Ancillary Study (SMAS) of the Cornea Donor Study. The multicenter, prospective, nonrandomized clinical trial took 173 subjects undergoing DSAEK for a moderate-risk condition (principally Fuchs' dystrophy or pseudophakic/aphakic corneal edema) and compared them with 410 subjects undergoing PK from the SMAS who had clear grafts with at least one postoperative specular image within a 15-month follow-up period. The DSAEK procedures were performed by two experienced surgeons per their individual techniques, using the same donor and similar recipient criteria as with the PK procedures in the SMAS, performed by 68 surgeons at 45 sites, with donors provided from 31 eye banks. Graft success and complications for the DSAEK group were assessed and compared with the SMAS group. Endothelial cell density was determined from baseline donor six-month (r: five to seven months) and 12-month (r: nine to 15 months) postoperative central endothelial images, by the same reading center used in the SMAS. Outcome was measured by endothelial cell density and graft survival at one year.
Although the DSAEK recipient group criteria were similar to the PK group, Fuchs' dystrophy was more prevalent in the DSAEK group (85 percent vs. 64 percent) and pseudophakic corneal edema was less prevalent (13 percent vs. 32 percent, p<0.001). The regraft rate within 15 months was 2.3 percent (DSAEK group) and 1.3 percent (PK group) (p=0.50). Percent endothelial cell loss was 34 ±22 percent versus 11 ±20 percent (six months) and 38 ±22 percent vs. 20 ±23 percent (12 months) in the DSAEK and PK groups, respectively (both p<0.001). Preoperative diagnosis affected endothelial cell loss over time; in the PK group, the subjects with pseudophakic/aphakic corneal edema experienced significantly higher 12-month cell loss than the subjects with Fuchs' dystrophy (28 percent vs. 16 percent, p=0.01), whereas in the DSAEK group, the 12-month cell loss was comparable for the two diagnoses (41 percent vs. 37 percent, p=0.59).
GDx Software May Be Useful in Tracking Progression
GDx Variable Corneal Comp-ensation (VCC) Guided Progression Analysis (GPA) software may be used to complement clinical evaluation in the detection of longitudinal change in glaucoma, according to an analysis of data from the Diagnostic Innovations in Glaucoma Study. The observational cohort study included 453 eyes from 252 individuals followed for an average of 46 ±14 months. At baseline, 29 percent of the eyes were classified as glaucomatous, 67 percent of the eyes were classified as suspects, and 5 percent of the eyes were classified as healthy. Images were obtained annually with the GDx VCC and analyzed for progression using the Fast Mode of the GDx GPA software. Progression using conventional methods was determined by the GPA software for standard automated achromatic perimetry, and by masked assessment of optic disc stereophotographs by expert graders. Sensitivity, specificity and likelihood ratios for detection of glaucoma progression using the GDx GPA were calculated with SAP and optic disc stereophotographs used as reference standards. Agreement among the different methods was reported using the AC1 coefficient.
Thirty-four of the 431 glaucoma and glaucoma suspect eyes (8 percent) showed progression by SAP or optic disc stereophotographs. The GDx GPA detected 17 of these eyes, for a sensitivity of 50 percent. Fourteen eyes showed progression only by the GDx GPA, with a specificity of 96 percent. Positive and negative LRs were 12.5 and 0.5, respectively. None of the healthy eyes showed progression by the GDx GPA, with a specificity of 100 percent in this group. Inter-method agreement (AC1 coefficient and 95 percent confidence intervals) for non-progressing and progressing eyes was 0.96 (0.94 to 0.97) and 0.44 (0.28 to 0.61), respectively.
Alencar LM, Zangwill LM, Weinreb RN, et al.
Study Raises Tolerability Concerns Over IV Infliximab
Not only is low-dose intra-vitreal infliximab (Remicade) not well-tolerated in some patients with refractory diabetic macular edema or choroidal neovascularization secondary to age-related macular degeneration, but it is also both immunogenic and probably retinotoxic, says a new study. The authors of the prospective, interventional, noncomparative, open-label, 12-week pilot study observed intravitreal infliximab in four patients who failed conventional therapies. Two had diabetic macular edema and two had choroidal neovascularization secondary to AMD. All patients received 0.5 mg/0.05 mL intravitreal infliximab and were eligible for a second injection at six weeks if reinjection criteria were met. Outcome measures were best-corrected visual acuity using standard ETDRS refraction, central retinal thickness on optical coherence tomography, fluorescein angiography, standard electroretinography and microperimetry. Patients were evaluated at days 0 and one and weeks two, six and 12. Six months after study completion, all patients were tested for human antimouse and human antichimeric antibodies.
At week 12, visual acuity scores had declined in three patients. All patients had persistence of cystoid macular edema on optical coherence tomography, although two had a decrease in central retinal thickness. Three patients had an overall worsened ap-pearance on angiography. On the final electroretinography, all patients had a decrease in maximal combined responses, from 7 percent to 24 percent from baseline, which may have been within expected variability of electroretinography data. To photopic flicker stimulus, three patients had slower latency of response, and all had decreased amplitudes. All patients declined on microperimetry. The first patient entered in the study met the criteria for a second injection because of improved standard electroretinography and microperimetry at week six. However, two weeks after the second injection, he developed panuveitis. Two other patients, after one injection only, had evidence of inflammation (vitritis or panuveitis) on examination at week six. Three patients developed systemic antibodies against infliximab (human antichimeric antibodies).
Giganti M, Beer PM, Lemanski N, et al.
New Treatments Show Potential for
Both the anterior juxtascleral depot of a drug and anecortave acetate demonstrate potential as promising candidates for intraocular pressure reduction in eyes with open-angle glaucoma, says a recent study. The authors of the prospective, interventional case series evaluated seven eyes of six subjects presenting with OAG with uncontrolled IOP while being administered one or more topical medications. Subjects then received 24 mg of anecortave acetate delivered by anterior juxtascleral depot. IOP was then assessed at baseline and regularly after treatment for up to 24 months.
Mean IOP before the anecortave acetate treatment was 31.3 ±11.3 mmHg, which then dropped by 9.5 ±4.5 mmHg (32.7 ±16.8 percent) within one week after treatment. This IOP reduction was sustained through the six months (8.4 ±5.4 mmHg [29.6 ±12.4 percent]) and 12 months (9.5 ±5.7 mmHg [34 ±15.9 percent]) following the single anecortave acetate treatment. The injection process was well-tolerated, and no eyes experienced any injection-related or drug-related serious adverse events.
Despite the positive results, additional studies are required to better establish the efficacy and safety, optimal dosing frequency, mechanism of action, and potential additivity to other IOP-lowering therapies.
Am J Ophthalmol 2009;147:45-50