Surgeons at the Department of Ophthalmology at Emory University, Atlanta, have reported three-year results of the Food And Drug Administration clinical trial of the Artisan/Verisyse phakic IOL. The prospective, open-label, noncomparative, multicenter trial enrolled 684 adults with axial myopia from -4.5 D to -22 D: 662 in the primary analysis group and 22 under compassionate use protocol expansion. Main outcome measures included uncorrected distance visual acuity, refractive predictability and stability, patient satisfaction and contrast sensitivity.

At three years, UCVAs for first eyes were 20/40 or better in 84 percent (194/231) and 20/25 or better in 51.9 percent (120/231). Of first eyes, 71.7 percent to 76.7 percent were within 0.5 D of target refraction and, 93.1 percent to 95 percent were within 1 D at six months and later. Best spectacle-corrected visual acuity was 20/40 or better for 99 percent to 100 percent of first eyes from the one-month visit through three years. At three years, 54 percent of first eyes gained greater than/equal to 1 lines of BSCVA, and 7.5 percent lost greater than/equal to 1 lines of BSCVA. The mean change in endothelial cell density from baseline to three years was -4.8 percent +/= 7.8 percent, with a 2.4-percent loss between two and three years. One site had a mean cell loss of -5 percent (p=0.023), and the others combined had a mean cell loss of 1.7 percent +/= 5.4 percent. For a cohort of 57 eyes with ECD data for all visits, the mean change from baseline was -3.8 percent +/= 9.8 percent over three years. Approximately half (31/59) of the adverse events and preventative repositionings were among the first 10 cases performed by each investigator.

(Ophthalmology 2008;115:464-472)

Stulting RD, John ME, Maloney RK, Assil KK, Arrowsmith PN, Thompson VM; U.S. Verisyse Study Group.

What Contributes to Opaque Bubble Layer

Thicker corneas and smaller flaps were associated with a more opaque bubble layer, a phenomenon associated with IntraLase femtosecond laser flaps, in a study by a group at the Toronto Western Hospital, University of Toronto, Ontario. The investigators assessed 79 consecutive patients (149 eyes) who had LASIK for myopic astigmatism, with a flap created using the IntraLase (15 Khz) laser. They documented the preop visual acuity, refraction, keratometry, pachymetry and intraoperative data, including flap size and thickness. A computerized system was used to calculate the total area of the OBL.

Eighty-four eyes (56.4 percent) developed an OBL. The layer pattern was diffuse in 32.2 percent of eyes and hard in 24.2 percent. The diffuse OBL covered a mean of 13.4 percent +/= 10 percent of the corneal flap and the hard OBL, a mean of 21.6 percent +/=10 percent (p=.0004). A significant correlation was noted between the corneal steep curvature and central corneal thickness and the area of OBL. Multivariate logistic regression found that flap diameter (p=.04) and CCT (p=.045) affected the occurrence and area of the OBL (p=.04 and p=.05, respectively). Postop diffuse lamellar keratitis was not associated with an OBL. Three months postoperatively, visual acuity and refraction were not affected by the bubble layer. There was an increase in trefoil aberrations in eyes with a hard OBL (p=.01).

The presence of an OBL did not seem to have detrimental long-term sequelae, although a small harmful effect could not be ruled out, the group concludes.

(J Cataract Refract Surg 2008;34:417-23.)

Kaiserman I, Maresky HS, Bahar I, Rootman DS.