Volume 9, Number 18
Monday, May 11, 2009



In this issue: (click heading to view article)
Effects of Pars Plana Vitrectomy in DME Over the Long Term
Impact of Topical Anesthetic Cataract Surgery on Ocular Alignment
Correlation of IOP, CCT and Corneal Hysteresis
Central Corneal Thickness and Cerebral Palsy
Briefly





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Effects of Pars Plana Vitrectomy in DME Over the Long Term

In this interventional, retrospective, consecutive case series, the authors reported the long-term results of pars plana vitrectomy for diffuse nontractional diabetic macular edema (DME). They reviewed the clinical records of 332 consecutive patients (496 eyes) with DME without a thickened and taut posterior hyaloid on contact lens examination (486 eyes of 326 consecutive patients were included in the study).

All patients underwent pars plana vitrectomy with the creation of a posterior vitreous detachment by one surgeon and the authors performed simultaneous phacoemulsification with intraocular lens implantation on 456 phakic eyes. Additionally, they performed internal limiting membrane peeling on 178 (36.6%) of 486 eyes and used best-corrected visual acuity (BCVA) results during follow-up periods as the main outcome measured.

While postop follow up ranged from 12 to 170 months (mean, 74.0 months), five-year follow-up data were available for 356 (71.8%) of 496 eyes. The authors reported that mean preoperative BCVA significantly increased from 0.19 (20/105) to 0.32 (20/63) at 1 year after surgery (p<0.0001) and 0.30 (20/67) at the final visit (p<0.0001). They noted that the final BCVA improved in 256 (52.7%) of the 486 eyes, remained unchanged in 152 eyes (31.3%) and worsened in 78 eyes (16.0%). Additionally, postop major complications included neovascular glaucoma in 19 eyes (3.9%), recurrent vitreous hemorrhage in 10 eyes (2.1%), hard exudates deposits in the center of the macula in 21 eyes (4.2%) and glaucoma in 22 eyes (4.5%).

In their conclusion, the authors reported that pars plana vitrectomy with and without internal limiting membrane peeling appears to be beneficial in eyes with diffuse nontractional DME and that its effectiveness is maintained long term.

SOURCE: Kumagai K, Furukawa M, Ogino N, et al. Long-term follow-up of vitrectomy for diffuse nontractional diabetic macular edema. Retina 2009;29(4):464-472






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Impact of Topical Anesthetic Cataract Surgery on Ocular Alignment

According to the findings of this prospective Korean study, topical anesthetic cataract surgery could abolish the risk of postoperative diplopia and improve the heterophoric status of pre-existing misalignment.

A total of 160 consecutive patients who were scheduled for cataract surgery under topical anesthesia were evaluated to report the incidence of, and change in ocular misalignment following topical anesthetic cataract surgery. All patients had a complete ophthalmic examination, which included ocular alignment evaluation just before and 1 day, 1 week, 3 weeks and 2 months after cataract surgery.

Preoperatively, 26 patients had ocular misalignment (mean deviation 7.2 ± 6.8 prism diopters [PD]). Postoperatively, the angle of deviation improved to 5.4 ± 7.4 PD. Furthermore, acquired ocular misalignment after cataract surgery occurred in 12 of 160 patients (8%) at 1 day and 7 of 131 (5%) at 2 months (none of the 7 patients sought medical attention for the diplopia). The overall incidence of topical anesthesia-related change in ocular alignment after uneventful cataract surgery was 5%. No patients experienced symptomatic diplopia.

SOURCE: Chung SA, Kim CY, Chang JH, et al. Change in ocular alignment after topical anesthetic cataract surgery. Graefes Arch Clin Exp Ophthalmol 2009; Apr 30 [Epub ahead of print].






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Correlation of IOP, CCT and Corneal Hysteresis

UK investigators aimed to examine the relationship between office-hour changes in IOP measured with the Goldmann applanation tonometry (GAT) and dynamic contour tonometer (DCT) as well as central corneal thickness (CCT) and corneal hysteresis (CH).

They measured IOP in 62 eyes of 62 untreated glaucoma or normal subjects with the GAT and DCT every 2 hours over an 8-hour period. They also measured CCT (µm) using a non-contact optical low-coherence reflectometry pachymeter and CH (mmHg) using the Reichert Ocular Response Analyzer.

The investigators observed that GAT, DCT and CCT changed significantly (ANOVA; GAT: F = 19.9, p<0.001; DCT: F = 4.6, p=0.001; CCT: F=16.4; p<0.001) but observed no significant changed in CH. Multilevel modeling of the inter-relationships between CCT, CH and age on IOP revealed that CCT and CH changes were significantly associated with GAT IOP changes (GAT IOP/CCT slope; 0.04 mmHg/µm, 95% CI 0.02 to 0.06; GAT IOP/CH slope 0.20 mmHg/mmHg, 95% CI 0.01 to 0.39). CCT changes were significantly associated with DCT IOP changes (DCT IOP/CCT slope: 0.03 mmHg/µm, 95% CI 0.00 to 0.05).

While the association between CCT and GAT IOP was relatively uniform between subjects, the association between CCT and DCT IOP showed greater inter-subject variability. Additionally, age had no effect.

Measured IOP and corneal characteristics co-vary during office hours, the investigators concluded. Also, changes in CCT and CH are associated with changes in GAT and, less consistently, with DCT. They state that their data suggest that variations in corneal characteristics may explain a small proportion of the change in IOP measurements made with the GAT during office hours.

SOURCE: Kotecha A, Crabb DP, Spratt A, Garway-Heath DF. The relationship between diurnal variations in intraocular pressure measurements and central corneal thickness and corneal hysteresis. Invest Ophthalmol Vis Sci 2009; Apr 30 [Epub ahead of print].







Central Corneal Thickness and Cerebral Palsy

Researchers evaluated central corneal thickness (CCT) values in the 77 children with cerebral palsy (CP) and 58 healthy control children (125 children total) enrolled in their study. They measured the CCT value by ultrasound pachymetry and took consecutive measurements from the center of the cornea of each eye.

The researchers found that the mean CCT value in the CP group was 568.46 ± 31.94 µm in the right eye and 568.01 ± 32.50 µm in the left eye. In the control group, the mean CCT value was 549.53 ± 26.16 µm in the right eye and 549.62 ± 27.58 µm in the left eye. They noted that the CCT value was significantly higher in the CP group than in the control group for both eyes (p<0.001) and that there was no statistically significant difference between the right and left eyes of children with CP and intellectual disability (ID) and those with CP and no ID (p=0.344 and 0.076, respectively).

Children with CP had an increased CCT compared with healthy control subjects. According to the researchers, they found no significant difference in CCT values between the children with and without ID in their CP group.

SOURCE: Cumurcu T, Cumurcu BE, Kilic R, et al. Increased central corneal thickness in children with cerebral palsy. Cornea 2009;28(4):375-378.

 




  • AZASITE THE SUBJECT OF TWO NEW CLINICAL TRIALS FOR BLEPHARITIS. Inspire Pharmaceuticals, Inc. is seeking a potential indication for the treatment of blepharitis for its azithromycin ophthalmic solution 1% (AzaSite), which is currently approved in the United States for the treatment of bacterial conjunctivitis. As part of its quest, the company has initiated two Phase 2 clinical trials. One is a randomized, placebo-controlled, multi-center trial at approximately 30 clinical sites evaluating the safety and efficacy of two weeks of AzaSite treatment compared to placebo in roughly 300 subjects with blepharitis (trial 044-101), while the other is a randomized, placebo-controlled, multi-center trial at about 30 clinical sites evaluating the safety and efficacy of four weeks of treatment with AzaSite compared to placebo in approximately 300 subjects with blepharitis (trial 044-102). Both trials will evaluate various signs and symptoms of blepharitis, as well as safety and tolerability and Inspire is expecting the results from each trial to be available in the first half of 2010.
  • NOVAGALI CLEARED FOR PHASE III GLAUCOMA TRIAL. The FDA recently granted Novagali Pharma's Investigational New Drug Application to conduct a Phase III clinical trial in the United States with Catioprost (Nova21027) for the treatment of glaucoma. According to Novagali, Catioprost is a topical ocular BAK-free emulsion of latanoprost that presents a safer profile than BAK-containing marketed products for glaucoma. The pivotal trial will evaluate the safety and the efficacy of the product. More information is available here.
  • PHASE 3 STUDIES PLANNED FOR 2009. Bayer HealthCare AG and Regeneron Pharmaceuticals, Inc. are extending their global development program for vascular endothelial growth factor (VEGF) Trap-Eye, an investigational agent for the treatment of certain eye disease, to include central retinal vein occlusion (CRVO). A recent press release reveals that the companies plan to initiate a Phase 3 program evaluating the efficacy and safety of VEGF Trap-Eye in the treatment of CRVO in the second half of 2009. The Phase 3 program in CRVO will consist of two multinational, one-year clinical studies that have been reviewed with regulatory authorities. The studies are anticipated to expand the companies' global development collaboration for VEGF Trap-Eye, which currently includes two ongoing Phase 3 studies in patients with neovascular AMD and a Phase 2 study in patients with diabetic macular edema and enrollment in both studies is expected to be complete later this year. For additional information, visit www.regeneron.com.
  • NEI TO RENEW KANSAS STATE PROFESSOR'S GRANT. The National Eye Institute of the National Institutes of Health has announced a four-year grant renewal for Kansas State University professor Gary Conrad's research that could improve LASIK surgery. Conrad and his research associates have identified a difference in the connective tissue of normal corneas compared to those that have been cut during LASIK. Thanks to the grant renewal, the researchers will be able to test a possible solution that would strengthen the stromal flap and allow it to permanently bind back to the cornea after LASIK using a combination of riboflavin and UVA light to permanently cross-link the connective tissue of the flap to the underlying corneal connective tissue. According to the Kansas State press release, the treatment is currently in U.S. clinical trials for keratoconus.
  • POSITIVE PHASE 1 RESULTS REPORTED BY OPHTHOTECH CORP. According to Ophthotech Corp., E10030, its novel anti-platelet derived growth factor (anti-PDGF) therapy, in conjunction with an anti-vascular endothelial growth factor (anti-VEGF), resulted in enhanced visual outcome and was associated with significant neovascular regression in a phase 1 clinical study to treat wet AMD. Of patients treated with anti-PDGF and anti-VEGF, 59% gained significant vision (3-line gain) at week 12 after therapy and 100% of treated patients demonstrated neovascular regression. Ophthotech reported that E10030 was well tolerated with no evidence of drug-related adverse events. Read the press release to learn more about E10030 or about the results of this trial.

 




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