TY - JOUR
T1 - A randomized multicenter clinical trial of ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) versus DSAEK
AU - Dickman, M.M.
AU - Kruit, P.J.
AU - Remeijer, L.
AU - van Rooij, J.
AU - van der Lelij, A.
AU - Wijdh, R.H.J.
AU - van den Biggelaar, F.J.H.M.
AU - Berendschot, T.T.J.M.
AU - Nuijts, R.M.M.A.
N1 - The Best of Anterior Segment specialty meeting, American Academy of Ophthalmology Annual Meeting, Las Vegas, NV, 2015.
PY - 2016/11
Y1 - 2016/11
N2 - Objective
To compare visual acuity, refraction, endothelial cell density (ECD), and complications after Descemet stripping automated endothelial keratoplasty (DSAEK) and ultrathin DSAEK (UT-DSAEK).
Design
A multicenter, prospective, double-masked, randomized, controlled clinical trial.
Participants
From 66 patients with irreversible corneal endothelial dysfunction dues to Fuchs' dystrophy who enrolled from 4 tertiary medical centers in the Netherlands, 66 eyes were studied.
Methods
Participants were centrally randomized to undergo either UT-DSAEK or DSAEK, based on preoperative best spectacle-corrected visual acuity (BSCVA), recipient central corneal thickness, patient age, and recruitment center. Donor corneas were precut by a single cornea bank.
Participants
Participants underwent ophthalmic examinations preoperatively and 3, 6, and 12 months after the operation, including manifest refraction, BSCVA using an Early Treatment Diabetic Retinopathy Study chart, and endothelium imaging.
Main Outcome Measures
BSCVA 12 months postoperatively.
Results
Preoperative BSCVA did not differ between patients undergoing DSAEK (0.35 logarithm of the minimum angle of resolution [logMAR] [95% confidence interval {CI} 0.27–0.43]; n = 32) and UT-DSAEK (0.37 logMAR [95% CI 0.31–0.43]; n = 34; P = 0.8). BSCVA was significantly better after UT-DSAEK compared with that after DSAEK at 3 months (0.17 logMAR [95% CI 0.13–0.21], n = 31 vs. 0.28 logMAR [95% CI 0.23–0.33], n = 31; P = 0.001), 6 months (0.14 logMAR [95% CI 0.10–0.18], n = 30 vs. 0.24 logMAR [95% CI 0.20–0.28], n = 30; P = 0.002), and 12 months (0.13 logMAR [95% CI 0.09–0.17], n = 33 vs. 0.20 logMAR [95% CI 0.15–0.25], n = 29; P = 0.03). Refraction, ECD loss (40% at 3 months; P < 0.001), donor loss (DSAEK n = 2 vs. UT-DSAEK n = 3 [relative risk {RR} 1.4 {95% CI 0.24–7.5}; P = 0.7]), and graft dislocation (DSAEK n = 5 vs. UT-DSAEK n = 5 [RR 1.0 {95% CI 0.34–3.33}; P = 0.9]) did not differ between UT-DSAEK and DSAEK.
Donor thickness was significantly thinner for UT-DSAEK (101 μm [95% CI 93–110 μm]; range 50–145 μm) than for DSAEK (209 μm [95% CI 196–222 μm]; range 147–289 μm; P < 0.001).
Conclusions
This study indicates that compared with DSAEK, UT-DSAEK results in faster and better recovery of BSCVA with similar refractive outcomes, endothelial cell loss, and incidence of complications.
AB - Objective
To compare visual acuity, refraction, endothelial cell density (ECD), and complications after Descemet stripping automated endothelial keratoplasty (DSAEK) and ultrathin DSAEK (UT-DSAEK).
Design
A multicenter, prospective, double-masked, randomized, controlled clinical trial.
Participants
From 66 patients with irreversible corneal endothelial dysfunction dues to Fuchs' dystrophy who enrolled from 4 tertiary medical centers in the Netherlands, 66 eyes were studied.
Methods
Participants were centrally randomized to undergo either UT-DSAEK or DSAEK, based on preoperative best spectacle-corrected visual acuity (BSCVA), recipient central corneal thickness, patient age, and recruitment center. Donor corneas were precut by a single cornea bank.
Participants
Participants underwent ophthalmic examinations preoperatively and 3, 6, and 12 months after the operation, including manifest refraction, BSCVA using an Early Treatment Diabetic Retinopathy Study chart, and endothelium imaging.
Main Outcome Measures
BSCVA 12 months postoperatively.
Results
Preoperative BSCVA did not differ between patients undergoing DSAEK (0.35 logarithm of the minimum angle of resolution [logMAR] [95% confidence interval {CI} 0.27–0.43]; n = 32) and UT-DSAEK (0.37 logMAR [95% CI 0.31–0.43]; n = 34; P = 0.8). BSCVA was significantly better after UT-DSAEK compared with that after DSAEK at 3 months (0.17 logMAR [95% CI 0.13–0.21], n = 31 vs. 0.28 logMAR [95% CI 0.23–0.33], n = 31; P = 0.001), 6 months (0.14 logMAR [95% CI 0.10–0.18], n = 30 vs. 0.24 logMAR [95% CI 0.20–0.28], n = 30; P = 0.002), and 12 months (0.13 logMAR [95% CI 0.09–0.17], n = 33 vs. 0.20 logMAR [95% CI 0.15–0.25], n = 29; P = 0.03). Refraction, ECD loss (40% at 3 months; P < 0.001), donor loss (DSAEK n = 2 vs. UT-DSAEK n = 3 [relative risk {RR} 1.4 {95% CI 0.24–7.5}; P = 0.7]), and graft dislocation (DSAEK n = 5 vs. UT-DSAEK n = 5 [RR 1.0 {95% CI 0.34–3.33}; P = 0.9]) did not differ between UT-DSAEK and DSAEK.
Donor thickness was significantly thinner for UT-DSAEK (101 μm [95% CI 93–110 μm]; range 50–145 μm) than for DSAEK (209 μm [95% CI 196–222 μm]; range 147–289 μm; P < 0.001).
Conclusions
This study indicates that compared with DSAEK, UT-DSAEK results in faster and better recovery of BSCVA with similar refractive outcomes, endothelial cell loss, and incidence of complications.
U2 - 10.1016/j.ophtha.2016.07.036
DO - 10.1016/j.ophtha.2016.07.036
M3 - Article
C2 - 27659544
SN - 0161-6420
VL - 123
SP - 2276
EP - 2284
JO - Ophthalmology
JF - Ophthalmology
IS - 11
ER -
