Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial.

Importance: Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. Objective: To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. Design, Setting, and Participants: A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). Interventions: Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). Main Outcomes and Measures: Graft success at 3 years. Results: Of the 1090 participants (1330 study eyes; 60.2% women and 39.8% men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3% (95% CI, 93.6%-96.9%) in the 0-7d PT group and 92.1% (95% CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95% CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4% in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95% CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5% (95% CI, 92.3%-98.4%) for PT of 4 days or less, 94.9% (95% CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95% CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3% (95% CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). Conclusions and Relevance: The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

Lodged intracanalicular plugs as a cause of lacrimal obstruction.

PURPOSE: To evaluate the complications and success of treatment of migrated or lodged intracanalicular and punctal plugs. METHODS: A retrospective chart review of all cases having either a dacryocystorhinostomy or surgical removal of an intracanalicular or punctal plug from 1992 to 2006, in a single physician referral oculoplastics practice, was performed to identify cases in which a retained lacrimal plug required surgical intervention. Patients presented with symptoms of tearing, infection, or granuloma formation. The charts of 998 surgical cases were reviewed, from which 66 eyes (6.6%) were determined to have had lodged lacrimal plugs that required surgical removal, thus qualifying them for inclusion in this study. Patients were followed after surgery until reconstructive silicone tubing was removed (range, 6 weeks to 6 months), and each patient was questioned regarding symptoms. A comparison group of 336 eyes that had collared punctal plugs placed served as the control group. RESULTS: All cases were noted to have complications from intracanalicular plugs. No complications were noted from other forms of lacrimal plugs. All eyes in this series required a canaliculotomy or a dacryocystorhinostomy after office irrigation failed to dislodge the plug. Five eyes presented with canaliculitis, 28 eyes presented with epiphora, and 29 eyes presented with dacryocystitis. Four of 66 eyes (6%) in this cohort presented with a pyogenic granuloma. Five eyes (8%) presented with canaliculitis. Forty-nine of 66 eyes (74%) were asymptomatic following treatment, with no observable infection or epiphora. Seven of 66 eyes (11%) had some improvement in symptoms and another 10 of 66 eyes (15%) had no change in symptoms after treatment. No complications requiring surgical intervention were encountered in the control group of collared punctal plugs. CONCLUSIONS: Intracanalicular-type plugs may lodge in the lacrimal outflow system. This may result in epiphora, canaliculitis, or dacryocystitis that may require major reconstructive surgery. Despite surgical intervention, these symptoms do not always resolve (26% of eyes in this study had persistent epiphora). Intracanalicular plugs were observed to be associated with a higher rate of granulation tissue formation in the lacrimal outflow tract when compared with other forms of punctal plugs. As a result of the increased number of complications seen with intracanalicular plugs, caution is advised with respect to use of these devices. The relative infrequency of complications seen with collared punctal plugs suggests a safer alternative. Data from this study lead the authors to advocate the consideration of other forms of lacrimal occlusion due to the high number of complications noted with intracanalicular plugs, and the availability of other reversible forms of punctal occlusion.

Temporal hinge laser in situ keratomileusis: maximizing treatable stromal bed area.

PURPOSE: To compare the treatable stromal bed area created by a temporal versus superior hinge laser in situ keratomileusis (LASIK) flap. SETTING: Assil Sinskey Eye Institute, Santa Monica, California, USA. METHODS: A randomized retrospective case review was performed of 2 subgroups (each with 12 eyes) of a cohort having LASIK for the correction of hyperopic astigmatism between August 2001 and March 2002. In 1 group, superior hinge LASIK was performed using the standard surgical technique for the 9.5 mm Hansatome suction ring. In the other group, the keratome was rotated 90 degrees such that a temporal hinge LASIK was performed with the 9.5 mm Hansatome suction ring. Corneal curvature (central mean keratometric value), flap diameter (arc length), and treatable stromal bed area were measured in each eye, and mean values were compared between the 2 groups. A treatable stromal bed area was defined as the circle centered over the entrance pupil, tangent to the hinge (devoid of hinge interference). RESULTS: The mean keratometry and mean flap diameter in the superior and temporal hinge groups measured 42.3 diopters (D) and 9.68 mm and 42.2 D and 9.69 mm, respectively. These differences were not significant (P=.882 for average keratometry and P=.943 for flap diameter). The mean treatable stromal bed area in the superior versus temporal hinge group measured 44.14 mm(2) and 62.25 mm(2), respectively. The difference between the 2 groups was highly significant (P<.0001). CONCLUSIONS: A large diameter, temporal hinge LASIK flap yielded a significantly greater area of treatable corneal stromal bed than a superior hinge flap. There are several clinical and theoretical advantages of optimizing stromal bed exposure for any given flap diameter.