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

Long-Term Outcomes of Deep Anterior Lamellar Keratoplasty Treating Posterior Stroma-Implicated Herpetic Corneal Opacities

Posted Posted in cornea
DALK,Deep Anterior Lamellar Keratoplasty,Herpes,Corneal Opacities
Cornea. 2016 Jan 16. [Epub ahead of print]

Long-Term Outcomes of Deep Anterior Lamellar Keratoplasty Treating Posterior Stroma-Implicated Herpetic Corneal Opacities.

Abstract

PURPOSE:

To evaluate the long-term outcomes of deep anterior lamellar keratoplasty for the management of deep stromal corneal opacities after herpes simplex keratitis (HSK) infection.

METHODS:

Case records of patients who underwent deep anterior lamellar keratoplasty between January 2006 and June 2012 to treat HSK-related deep stromal corneal scars were retrospectively analyzed. The cases were divided into folds-on, folds-off, and no-folds groups based on the presence of stromal folds intraoperatively. The main outcome measures were best-corrected visual acuity, endothelial cell density, and complications.

RESULTS:

A total of 89 patients (89 eyes; 54 men and 35 women; 47.1 ± 12.9 years old) were included. Based on intraoperative events, 48 eyes had no stromal folds, 27 eyes had folds that were centrally peeled off, and 14 eyes had folds that could not be peeled. The average follow-up period was 50.4 ± 12.7 months. The mean best-corrected visual acuity improved from 1.63 ± 60.52 logMAR preoperatively to 0.44 ± 0.31 logMAR at the last visit (P < 0.001). Mean postoperative endothelial cell density was 1738 ± 573 cells per square millimeter. Eight eyes experienced HSK recurrence, 3 eyes had an episode of stromal rejection, and 3 eyes developed corneal endothelial decompensation. Cases in the folds-off group had a significantly higher rate of Descemet membrane microperforations compared with the other groups.

CONCLUSIONS:

Deep anterior lamellar keratoplasty is a viable alternative for the management of HSK-related deep stromal opacity. Although posterior corneal folds can be relieved intraoperatively in some of these cases, folds near Descemet membrane should be left in situ because of the high risk of Descemet membrane perforation.

CONCLUSIONS:

Deep anterior lamellar keratoplasty is a viable alternative for the management of HSK-related deep stromal opacity. Although posterior corneal folds can be relieved intraoperatively in some of these cases, folds near Descemet membrane should be left in situ because of the high risk of Descemet membrane perforation.

An analysis of factors influencing quality of vision after big-bubble deep anterior lamellar keratoplasty in keratoconus.

Posted Posted in cornea
Am J Ophthalmol. 2015 Nov 14. pii: S0002-9394(15)00706-0. doi: 10.1016/j.ajo.2015.11.018. [Epub ahead of print]

An analysis of factors influencing quality of vision after big-bubble deep anterior lamellar keratoplasty in keratoconus.

Abstract

PURPOSE:

To identify causes of reduced visual acuity and contrast sensitivity after big-bubble deep anterior lamellar keratoplasty (DALK) in keratoconus.

DESIGN:

Prospective interventional case series.

METHODS:

This study included 36 eyes in 36 patients with keratoconus who underwent DALK using the big-bubble technique. A bare Descemet membrane was achieved in all cases. Univariate analyses and multiple linear regression were used to investigate recipient-, donor-, and postoperative-related variables capable of influencing the postoperative quality of vision, including best-spectacle corrected visual acuity (BSCVA) and contrast sensitivity.

RESULTS:

The mean patient age was 27.7±6.9 years old, and the patients were followed for 24.6±15.1 months postoperatively. The mean postoperative BSCVA was 0.17±0.09 LogMAR. Postoperative BSCVA ≥ 20/25 was achieved in 14 eyes (38.9%), whereas a BSCVA of 20/30, 20/40, or 20/50 was observed in 15 eyes (41.7%), six eyes (16.6%), and one eye (2.8%), respectively. Preoperative vitreous length was significantly associated with postoperative BSCVA (β=0.02, P=0.03). Donor-recipient interface reflectivity significantly influenced scotopic (β=-0.002, P=0.04) and photopic (β=-0.003, P=0.02) contrast sensitivity. The root mean square of tetrafoil was significantly negatively associated with scotopic (β=-0.25, P=0.01) and photopic (β=-0.23, P=0.04) contrast sensitivity. Recipient age, keratoconus severity, donor-related variables, recipient trephination size, and graft and recipient bed thickness were not significantly associated with postoperative visual acuity or contrast sensitivity.

CONCLUSION:

Large vitreous length, higher-order aberrations, and surgical interface haze may contribute to poor visual outcomes after big-bubble DALK in keratoconus.

RESULTS:

The mean patient age was 27.7±6.9 years old, and the patients were followed for 24.6±15.1 months postoperatively. The mean postoperative BSCVA was 0.17±0.09 LogMAR. Postoperative BSCVA ≥ 20/25 was achieved in 14 eyes (38.9%), whereas a BSCVA of 20/30, 20/40, or 20/50 was observed in 15 eyes (41.7%), six eyes (16.6%), and one eye (2.8%), respectively. Preoperative vitreous length was significantly associated with postoperative BSCVA (β=0.02, P=0.03). Donor-recipient interface reflectivity significantly influenced scotopic (β=-0.002, P=0.04) and photopic (β=-0.003, P=0.02) contrast sensitivity. The root mean square of tetrafoil was significantly negatively associated with scotopic (β=-0.25, P=0.01) and photopic (β=-0.23, P=0.04) contrast sensitivity. Recipient age, keratoconus severity, donor-related variables, recipient trephination size, and graft and recipient bed thickness were not significantly associated with postoperative visual acuity or contrast sensitivity.

CONCLUSION:

Large vitreous length, higher-order aberrations, and surgical interface haze may contribute to poor visual outcomes after big-bubble DALK in keratoconus.

Copyright © 2015 Elsevier Inc. All rights reserved.

Changing indications and surgical techniques for corneal transplantation between 2004 and 2009 at a tertiary referral center.

Posted Posted in cornea
Corneal Transplantation, Deep Anterior Lamellar Keratoplasty,Lamellar Keratoplasty
Middle East Afr J Ophthalmol. 2012 Jul-Sep;19(3):323-9. doi: 10.4103/0974-9233.97941.

Changing indications and surgical techniques for corneal transplantation between 2004 and 2009 at a tertiary referral center.

Abstract

PURPOSE:

The aim of this study is to report the indications, techniques, and clinical outcomes of corneal transplantation and investigate any changing trends in surgical techniques over a 6 year period.

MATERIALS AND METHODS:

Records of patients who had undergone any kind of corneal transplantation at Labbafinejad Medical Center, Tehran, Iran, from January 2004 to December 2009 were reviewed to determine the indications and types of corneal transplantation. Postoperative best-corrected visual acuity, refractive error, graft clarity, and complications were reported.

RESULTS:

During this period, 1859 eyes of 1624 patients with a mean age of 41.3 ± 21.3 years underwent corneal transplantation. The most common indication was keratoconus (38.4%) followed by aphakic/pseudophakic bullous keratopathy (11.7%), previous failed grafts (10.6%), infectious corneal ulcers (10.1%), non-herpetic corneal scars (7.6%), trachoma keratopathy (4.7%), stromal corneal dystrophies (4.6%), post-herpeticcorneal scar (3.7%), Fuchs’ endothelial dystrophy (0.8%), and congenital hereditary endothelial dystrophy (0.4%). Techniques of corneal transplantation included penetrating keratoplasty (PKP; 70.9%), deep anterior lamellar keratoplasty (DALK; 20.1%), conventional lamellar keratoplasty (LKP; 4.4%), and Descemet’s stripping automated endothelial keratoplasty (DSAEK; 2.3%). Over the study period, there was a significant increase in the relative frequency of infectious corneal ulcers, failed grafts, and trachoma keratopathy. Additionally, a significant reduction was observed in PKP and LKP procedures, and volume of DALK and DSAEK increased significantly. At final follow-up, 69.0% of grafts were clear in the PKP group. This figure was 82.6%, 82.7%, and 97.6% in the DALK, LKP, and DSAEK groups, respectively.

CONCLUSION:

Keratoconus was the most common indication and PKP was the most prevalent technique used for corneal transplantation. However, significant changes in the indications and surgical techniques were observed from 2004 to 2009.

KEYWORDS:

Corneal Transplantation; Deep Anterior Lamellar Keratoplasty; Descemet Stripping Automated Endothelial Keratoplasty; Indication; Lamellar Keratoplasty; Penetrating Keratoplasty; Surgical Technique