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

Posted Posted in cornea

Cornea Preservation, Descemet Stripping Automated Endothelial Keratoplasty

2017 Nov 10. doi: 10.1001/jamaophthalmol.2017.4989. [Epub ahead of print]

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

Abstract

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.

Cornea Preservation, Descemet Stripping Automated Endothelial Keratoplasty REGISTRATION:

clinicaltrials.gov Identifier: NCT01537393.

PMID:
29127431
DOI:
10.1001/jamaophthalmol.2017.4989

Meta-Analysis of Postoperative Outcome Parameters Comparing Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty

Posted Posted in cornea
Analysis,Postoperative,Descemet Membrane Endothelial Keratoplasty, Descemet Stripping Automated Endothelial Keratoplasty
2017 Sep 26. doi: 10.1097/ICO.0000000000001384. [Epub ahead of print]

Meta-Analysis of Postoperative Outcome Parameters Comparing Descemet Membrane Endothelial Keratoplasty Versus Descemet Stripping Automated Endothelial Keratoplasty.

Abstract

PURPOSE:

This meta-analysis compares Descemet membrane endothelial keratoplasty (DMEK) with Descemet stripping automated endothelial keratoplasty (DSAEK) to evaluate their strength and weakness profiles.

DESIGN:

Meta-analysis.

METHODS:

We performed a meta-analysis and searched the peer-reviewed literature in PubMed, Cochrane Library, Web of Science, and Embase following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Prospective and retrospective trials performing and comparing DMEK and DSAEK were included. Effects were calculated as odds ratios or standardized mean differences.

RESULTS:

A total of 11 studies with a total of 723 eyes (350 DMEK and 373 DSAEK) were included. No significant difference was found regarding the total detachment rate, graft failure, and rejection. One of 340 eyes undergoing DMEK showed total detachment and 5 of 363 eyes undergoing DSAEK showed total detachment (P = 0.28). Six of 280 eyes undergoing DMEK showed graft failure; 1 of 313 eyes undergoing DSAEK developed this complication (P = 0.18). No rejection was observed in 158 eyes undergoing DMEK; 4 cases of rejection occurred in 196 eyes undergoing DSAEK (P = 0.37). No significant difference was found regarding endothelial cell loss (P = 0.48). There was a significantly higher partial detachment rate with DMEK: 88 of 340 eyes undergoing DMEK showed partial detachment; 16 of 363 eyes undergoing DSAEK showed this complication (P < 0.00001). DMEK was superior in best-corrected visual acuity after 6 months (P < 0.001), subjective evaluation of visual acuity (P = 0.001), patient satisfaction (P < 0.001), and was the method preferred by patients (P = 0.001).

CONCLUSIONS:

DMEK and DSAEK have a similar complication profile. However, the superiority in the visual outcome and patient satisfaction makes DMEK the preferred option for most patients.

Analysis,Postoperative,Descemet Membrane Endothelial Keratoplasty, Descemet Stripping Automated Endothelial Keratoplasty

 

PMID:
28957976
DOI:
10.1097/ICO.0000000000001384