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Deep Anterior Lamellar Keratoplasty as an Alternative to Penetrating ...

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Reinhart et al <strong>Deep</strong> <strong>Anterior</strong> <strong>Lamellar</strong> <strong>Kera<strong>to</strong>pl<strong>as</strong>ty</strong>Rostron’s DALK procedures generally use fullthickness,lyophilized donor lenticules, where<strong>as</strong> Sugita <strong>an</strong>dKondo’s 7 earlier efforts used cryolathed lenticules. Glycerin-cryopreservedcorneal tissue h<strong>as</strong> also been acceptable. 14One study specifically compared eyes that had receivedlyophilized donor corne<strong>as</strong> or donor corne<strong>as</strong> kept in OptisolGS (Bausch & Lomb, Inc., Rochester, NY) <strong>an</strong>d found nostatistical differences between the 2 methods of donor cornealpreservation. 15 According <strong>to</strong> the recent literature, mostsurgeons use full-thickness donor lenticules obtained fromcorneal sclera rims preserved in intermediate s<strong>to</strong>rage media(e.g., Optisol GS) or org<strong>an</strong> culture media, <strong>as</strong> is common inEurope. The donor endothelium c<strong>an</strong> be removed with a drysurgical sponge. However, m<strong>an</strong>y surgeons also remove DM.In either c<strong>as</strong>e, the posterior face of the donor graft will havea smooth interface apposed <strong>to</strong> the smooth bed of the exposed(bared) host DM. The <strong>an</strong>tigenic load of the donor isalso decre<strong>as</strong>ed by removing the endothelial cells. In DALKprocedures where some residual stroma remains, the interfacewill not be <strong>as</strong> regular, <strong>an</strong>d presumably even less regularif the donor lenticule h<strong>as</strong> also been obtained through surgicaldissection, such <strong>as</strong> described by Tsubota et al 16 <strong>an</strong>dP<strong>an</strong>da et al. 17Question for AssessmentThe objective of this <strong>as</strong>sessment is <strong>to</strong> address the followingquestion: How does DALK compare with PK for the outcomesof BSCVA, refractive error, rejection, <strong>an</strong>d graftsurvival?Description of EvidenceA search of the peer reviewed English-l<strong>an</strong>guage literaturew<strong>as</strong> conducted in the PubMed datab<strong>as</strong>e on December 14,2006, <strong>an</strong>d Oc<strong>to</strong>ber 1, 2007, <strong>an</strong>d a search of the Cochr<strong>an</strong>eLibrary datab<strong>as</strong>e w<strong>as</strong> conducted on December 18, 2006, <strong>an</strong>dOc<strong>to</strong>ber 1, 2007, limited <strong>to</strong> citations starting in 1997. Keywords in the search were the MeSH heading corneal tr<strong>an</strong>spl<strong>an</strong>tationcombined with text words deep <strong>an</strong>terior lamellarkera<strong>to</strong>pl<strong>as</strong>ty or DALK or deep lamellar kera<strong>to</strong>pl<strong>as</strong>ty orDescemet’s membr<strong>an</strong>e baring or maximum depth <strong>an</strong>teriorlamellar kera<strong>to</strong>pl<strong>as</strong>ty. The authors <strong>as</strong>sessed the 236 citationsresulting from the electronic searches <strong>an</strong>d selected 88citations that definitely or potentially met the inclusioncriteria.The authors obtained the full copy of these 88 articles forfurther <strong>as</strong>sessment. The reviewers were not m<strong>as</strong>ked <strong>to</strong> trialresults or publication details. The authors reviewed the full tex<strong>to</strong>f these articles <strong>to</strong> <strong>as</strong>sess their inclusion according <strong>to</strong> theselection criteria. One additional article w<strong>as</strong> identified fromreview of <strong>an</strong> article reference list. The authors selected 42articles for methodological review, <strong>an</strong>d they chose <strong>an</strong> additional19 articles <strong>to</strong> send <strong>to</strong> the first author for <strong>as</strong>sist<strong>an</strong>ce inwriting the first draft. These 19 articles were review articles,single-c<strong>as</strong>e reports of complications, or single-c<strong>as</strong>e reports oftechnique, <strong>an</strong>d they did not receive methodological review.The methodologist <strong>as</strong>signed ratings of level of evidence<strong>to</strong> each of the selected articles. A level I rating w<strong>as</strong> <strong>as</strong>signed<strong>to</strong> well-designed <strong>an</strong>d well-conducted r<strong>an</strong>domized clinicaltrials; a level II rating w<strong>as</strong> <strong>as</strong>signed <strong>to</strong> well-designed c<strong>as</strong>econtrol<strong>an</strong>d cohort studies or poor-quality r<strong>an</strong>domized clinicaltrials; <strong>an</strong>d a level III rating w<strong>as</strong> <strong>as</strong>signed <strong>to</strong> c<strong>as</strong>e series,c<strong>as</strong>e reports, <strong>an</strong>d poor-quality c<strong>as</strong>e-control or cohort studies.Two studies were r<strong>an</strong>domized controlled trials that wererated <strong>as</strong> level II evidence because of insufficient power, lackof m<strong>as</strong>king, <strong>an</strong>d a less rigorous r<strong>an</strong>domization method. 15,18All other articles were comparative <strong>an</strong>d noncomparativec<strong>as</strong>e series, prospective <strong>an</strong>d retrospective, or c<strong>as</strong>e reports<strong>an</strong>d were rated <strong>as</strong> level III evidence.An updated search, conducted on May 28, 2009, includedthe additional search term penetrating kera<strong>to</strong>pl<strong>as</strong>ty(MeSH <strong>an</strong>d text) <strong>an</strong>d retrieved 788 citations, of which <strong>an</strong>additional 73 possibly relev<strong>an</strong>t studies were identified <strong>an</strong>dreviewed. Of these, 13 were judged relev<strong>an</strong>t. In addition,surveill<strong>an</strong>ce of the literature identified more recent relev<strong>an</strong>tpublications. These additional studies were rated <strong>as</strong> level IIIevidence.Published ResultsDetailed descriptions <strong>an</strong>d Tables (1–6) of the outcomesfrom the included studies are included in the Appendix(available at http://aaojournal.org).Eleven published studies were identified in which theoperative <strong>an</strong>d pos<strong>to</strong>perative results of DALK <strong>an</strong>d PK procedureswere compared directly. Only 1 study 18 w<strong>as</strong> <strong>as</strong>signeda level II rating, <strong>an</strong>d the other 10 studies were rated<strong>as</strong> level III. All were single-institution studies, often withone operative surgeon, <strong>an</strong>d attempts were made <strong>to</strong> controlfor common fac<strong>to</strong>rs such <strong>as</strong> diagnosis or age. These 11studies are particularly useful for comparing the visual,refractive, early pos<strong>to</strong>perative ECD results, <strong>an</strong>d surgicalcomplications of the 2 procedures. These data are presentedin Table 1 (available at http://aaojournal.org). The DALKdata from 10 of these 11 studies were then abstracted <strong>an</strong>dcompiled along with DALK data from 31 other clinicalstudies (1 study rated <strong>as</strong> level II <strong>an</strong>d 30 rated <strong>as</strong> level III) <strong>to</strong>obtain a broader view of the operative complications ofDALK, <strong>as</strong> well <strong>as</strong> pos<strong>to</strong>perative visual, refractive, <strong>an</strong>d ECDdata. The results of those 41 studies are presented, in part,in Table 2 (available at http://aaojournal.org).The 11 identified clinical comparative DALK/PK studiesinclude data on a <strong>to</strong>tal of 481 eyes that had DALK <strong>an</strong>d 501eyes that had PK. Eight studies had 26 eyes in eachgroup, 17–24 one study had 41 DALK <strong>an</strong>d 43 PK eyes, 25 onestudy had 135 DALK <strong>an</strong>d 76 PK eyes, 26 <strong>an</strong>d one study had150 in each group. 27 Seven of the studies 19–24,26 enrolledonly patients with kera<strong>to</strong>conus, one study enrolled onlypatients with lattice or macular corneal dystrophy, 25 <strong>an</strong>d theremaining 3 studies included various corneal stromaldise<strong>as</strong>es. 17,18,27Table 3 (available at http://aaojournal.org) lists the reportedcomplications for the 1843 eyes in the 41 studies forpl<strong>an</strong>ned DALK procedures only. The most common operativecomplication w<strong>as</strong> DM perforation(s), which occurredin 11.7% of c<strong>as</strong>es. Air or g<strong>as</strong> injections in<strong>to</strong> the <strong>an</strong>teriorchamber at the time of surgery or in the pos<strong>to</strong>perative period211

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