Clinical Outcomes Of Descemet Stripping Automated

Endothelial Keratoplasty In A Series Of 218 Cases

Bryan Y Kim 1,

Shintaro Kanayama MD PhD 1, Tueng T Shen MD PhD 1, Thomas E Gillette MD 2

1 University of Washington Department of Ophthalmology, 2 Eye Associates Northwest,

Seattle, WA

April 7, 2010

Financial Disclosure:

The authors have no financial interest in the subject matter of this poster.

Background / Purpose

BACKGROUND• Descemet’s stripping automated endothelial keratoplasty (DSAEK) is the most widely

performed endothelial keratoplasty. (1)

• Numerous benefits over penetrating keratoplasty (PKP) for treatment of corneal endothelial disease including less induced astigmatism, shorter visual recovery, and better tectonic support.

• Few studies exist on outcomes of DSAEK performed with concurrent procedures such as cataract phacoemulsification and intraocular lens implantation (PE/IOL) or IOL exchange. (2,3,4)

PURPOSE• To report clinical outcomes of a large retrospective study of DSAEK and to compare

to existing published data. • To compare clinical outcomes of DSAEK performed with concurrent procedures to

DSAEK performed alone.

1. Lee WB et al. Descemet’s Stripping Endothelial Keratoplasty: Safety and Outcomes. Ophthalmology 2009;116:1818-1830.2. Terry MA et al. Endothelial Keratoplasty for Fuchs’ Dystrophy with Cataract. Ophthalmology 2009;116:631-639.3. Covert DJ, Koenig SB. New Triple Procedure: Descemet’s Stripping and Automated Endothelial Keratoplasty Combined with Phacoemulsification and Intraocular Lens Implantation.

Ophthalmology 2007;114:1272-12774. Shah AK et al. Complications and Clinical Outcomes of Descemet Stripping Automated Endothelial Keratoplasty With Intraocular Lens Exchange. Am J Ophthalmology 2010;149:390-397.

MethodsSTUDY METHODS

• Retrospective, nonrandomized case series of 218 consecutive DSAEK operations.

• Performed between April 2006 and April 2009 by a single surgeon (TEG) at an ambulatory surgery center.

• Chart review performed with approval of and in accordance with policies of institutional review board of parent medical center.

• Statistical analysis– Visual acuity measured by Snellen BCVA.

Pinhole VA used when manifest refraction not available.

– BCVA converted to logMAR for analysis. – Groups compared using Student’s T test,

ANOVA, and Chi-squared test with statistical significance at P<0.05. For small n values, Fisher’s exact test and randomization test for goodness-of-fit were used.

SURGICAL METHODS

• DSAEK technique– Anesthesia by retrobulbar block and IV

sedation. – Anterior chamber entered through 5.0mm

temporal corneal incision and paracentesis. – 6.5-8.5mm diameter descemetorhexis. – Graft dissected with Moria CB microkeratome

and trephinated to match stripping area. – Graft inserted in 40/60 taco configuration,

placed into position, and unfolded with air.– Anterior chamber filled with air for 10 minutes

to promote graft adhesion. – Air replaced by small bubble and incisions

made in host cornea as needed to drain residual fluid.

– Postoperatively, patient remained supine for 1 hour.

• If performed, concurrent surgical procedures (PE/IOL or IOL exchange) were performed prior to DSAEK.

Results

Preoperative Clinical Data

• Most patients received DSAEK for treatment of Fuch’s dystrophy or pseudophakic corneal edema.

• “Pseudophakic/aphakic corneal edema” includes 3 cases of aphakic corneal edema.

• “Other corneal edema” includes 1 Descemet’s detachment and 8 unspecified corneal edema.

No. (%)Demographics

Total DSAEK procedures 218 Age, yrs (mean ± SD) 72 ± 12, Range (5-95) Female: 135 62% Male: 83 38%

Distinct Eyes 194 Distinct Patients 155

DSAEK Indication Fuchs' dystrophy 130 60% Pseudophakic/aphakic corneal edema 35 16% PKP graft failure 20 9% Repeat DSAEK due to primary graft failure 13 6% Repeat DSAEK due to dislocated graft 6 3% Repeat DSAEK due to endothelial rejection 5 2% Other corneal edema 9 4%

Concurrent Procedures PE/IOL 88 40% IOL Exchange 16 7% Other (iridotomy, vitrectomy, IOL scleral fixation) 3 1.4% None 111 51%

Results

Overall Complications

• Comparative complication rates reported in a DSAEK outcomes literature review by Lee et al. (1):– Average graft dislocation rate: 14.5% (range 0-82%)– Average endothelial rejection rate: 10% (range 0-45%)– Average primary graft failure rate: 5% (range 0-29%)

1. Lee WB et al. Ophthalmology 2009;116:1818-1830.

No. (%)Total Cases 218

Graft dislocationReposition only 4 1.8%Repeat DSAEK or PKP after dislocation 8 3.7%

Total 12 5.5%

Endothelial Rejection 6 2.8%

Primary graft failureRepeat DSAEK after primary graft failure 14 6.4%PKP after primary graft failure 7 3.2%

Total 21 9.6%

Snellen BCVA PreOp 1 Day 1 Week 1 Month 6 MonthsMean 20/124 20/262 20/132 20/54 20/5020/20 or better 0.5% - 0.5% 1.1% 3.1%20/40 or better 27% 2.4% 21% 43% 64%20/100 or better 64% 26% 57% 79% 88%20/200 or better 71% 47% 68% 87% 91%

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ResultsOverall Visual Acuity Outcomes

LogMAR BCVA Snellen BCVA

• Comparative VA outcomes reported by Lee et al.: (1)

– Mean VA over 3 to 21 month follow up periods ranged from 20/34 to 20/66.– Percentage seeing 20/40 or better ranged from 38% to 100% (from 3 to 20 months)

1. Lee WB et al. Ophthalmology 2009;116:1818-1830.

LogMAR BCVA PreOp 1 Day 1 Week 1 Month 6 MonthsMean 0.79 1.12 0.82 0.43 0.40SD 0.58 0.53 0.56 0.34 0.32N 215 203 206 181 162

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7.50mm 7.75mm 8.00mm 8.25mm 8.50mm PreoperativeDemographics No. % No. % No. % No. % No. % P Value

No. 23 17 134 31 9Female 20 87% 7 41% 83 62% 15 48% 8 89%Male 3 13% 10 59% 51 38% 16 52% 1 11% 0.07Age 71 ±16 (range 33-90) 70 ±8 (range 55-82) 74 ±10 (range 43-95) 68 ±10 (range 47-84) 68 ±24 (range 17-95) 0.08

Complications No. Rate No. Rate No. Rate No. Rate No. RateGraft dislocation 2 9% 2 12% 4 3% 1 3% 2 22% 0.07Endothelial rejection - - - - 4 3% 1 3% 1 11% 0.47Primary DSAEK graft failure 4 17% 3 18% 12 9% 2 6% - - 0.42 Total 6 26% 5 29% 20 15% 4 13% 3 33% 0.34

Preoperative 6 Month Postoperative7.50mm 7.75mm 8.00mm 8.25mm 8.50mm P Value 7.50mm 7.75mm 8.00mm 8.25mm 8.50mm P Value

Visual AcuityLogMAR mean BCVA 1.01 1.01 0.75 0.56 0.98 0.02 0.51 0.55 0.40 0.42 0.37 0.73

Standard deviation 0.60 0.62 0.56 0.48 0.64 0.44 0.55 0.40 0.48 0.46

Snellen mean BCVA 20/206 20/202 20/111 20/73 20/190 20/64 20/71 20/51 20/52 20/47

% 20/20 or better - - 0.7% - - 1.00 - - 5% - - 0.47% 20/40 or better 4% 18% 30% 39% 22% 0.13 44% 50% 65% 76% 83% 0.69% 20/100 or better 57% 47% 66% 84% 44% 0.49 75% 83% 90% 86% 83% 0.98% 20/200 or better 57% 53% 75% 87% 56% 0.55 94% 83% 92% 86% 83% 0.99

ResultsComparison by Donor Graft Diameter

No significant difference in outcomes between graft diameters for:• Complication rates• 6 month postoperative BCVA

Visual Acuity

Demographics and Complications

DSAEK w/ PE/IOL DSAEK alone P valueDemographics No. % No. %

No. 88 41Female 57 65% 27 66% 0.91Male 31 35% 14 34%Age 68 ± 10 (range 43-84) 76 ± 7 (range 58-90) <0.001

Complications No. Rate No. RateGraft dislocation 2 2% 2 5% 0.59Endothelial rejection 3 3% - - 0.55Primary graft failure 4 5% 4 10% 0.26

Preoperative 6 Month PostoperativeDSAEK DSAEK DSAEK DSAEK

Visual Acuity w/ PE/IOL Alone P value w/PEIOL Alone P value

No. 88 41 72 31LogMAR mean BCVA 0.41 0.57 0.01 0.26 0.36 0.04

Standard deviation 0.29 0.33 0.22 0.22

Snellen mean BCVA 20/51 20/75 20/36 20/46

% 20/20 or better 1.1% - 1.00 7% - 0.32% 20/40 or better 56% 22% <0.001 85% 71% 0.14% 20/100 or better 92% 83% 0.17 96% 94% 0.65% 20/200 or better 95% 93% 0.55 99% 97% 0.60

Results

• 129 total DSAEK performed to treat Fuchs’ dystrophy.

• 88 DSAEK performed with concurrent PE/IOL (triple procedure).

• 41 DSAEK performed alone.

• No significant difference of:• Complication rates.• Percentages of patients at

various VA’s at 6 months.

• Significant difference:• Mean BCVA of DSAEK

performed with PE/IOL better than without at 6 months.

Comparison of DSAEK for Fuch’s DystrophyWith or Without Concurrent PE/IOL

Visual Acuity

Demographics and Complications

DSAEK w/ IOL Exc DSAEK alone P valueDemographics No. % No. %

No. 16 111Female 6 38% 70 63% 0.07Male 10 63% 41 37%Age 82 ± 10 (range 64-95) 74 ± 14 (range 5-95) 0.01

Complications No. Rate No. RateGraft dislocation 1 6% 9 8% 1.00Endothelial rejection - - 3 3% 1.00Primary graft failure - - 15 14% 0.21

Preoperative 6 Month PostoperativeDSAEK DSAEK DSAEK DSAEK

Visual Acuity w/ IOL Exc Alone P value w/ IOL Exc Alone P value

No. 16 111 13 76LogMAR mean BCVA 1.09 1.06 0.86 0.76 0.54 0.27

Standard deviation 0.64 0.57 0.67 0.46

Snellen mean BCVA 20/249 20/228 20/116 20/69

% 20/20 or better - - 1.00 - - 1.00% 20/40 or better - 8% 0.60 23% 51% 0.05% 20/100 or better 56% 43% 0.33 77% 82% 0.69% 20/200 or better 56% 54% 0.88 77% 86% 0.48

Results

• 16 DSAEK performed with concurrent IOL exchange

• 15 due to pseudophakic corneal edema

• 1 due to PKP graft failure

• 111 DSAEK performed alone• Multiple indications

• No significant difference of:• Complication rates• Mean BCVA at 6 months. • Percentages of patients at

most VA’s at 6 months.

• Significant difference:• Higher percentage of

patients receiving DSAEK alone had 20/40 VA or better at 6 months.

Comparison of DSAEK With or Without Concurrent IOL Exchange

Visual Acuity

Demographics and Complications

Conclusions

• Overall DSAEK outcomes for our series of 218 eyes are comparable with existing literature data.

• Concurrent PE/IOL implantation does not lead to worse visual outcomes or higher complication rates when compared to DSAEK alone.

• Similarly, concurrent IOL exchange generally does not lead to worse visual outcomes or higher complication rates compared to DSAEK alone.

• Donor graft diameter from 7.5mm to 8.5mm does not have a significant affect on visual outcomes or complication rates.

• This study data strengthens the existing literature supporting DSAEK as an effective treatment for corneal endothelial disease and further provides evidence that PE/IOL and IOL exchange can safely and efficaciously be performed concurrently with DSAEK.

References

• Chen ES et al. Descemet-Stripping Endothelial Keratoplasty: Six-month Results in a Prospective Study of 100 Eyes. Cornea 2008;27:514-520.

• Covert DJ, Koenig SB. New Triple Procedure: Descemet’s Stripping and Automated Endothelial Keratoplasty Combined with Phacoemulsification and Intraocular Lens Implantation. Ophthalmology 2007;114:1272-1277

• Gorovoy MS. Descemet-Stripping Automated Endothelial Keratoplasty..Cornea 2006;25:886-9.

• Koenig SB, Covert DJ. Early Results of Small-Incision Descemet’s Stripping Endothelial Keratoplasty. Ophthalmology 2007;114:221-26

• Koenig SB et al. Visual Acuity, Refractive Error, And Endothelial Cell Density Six Months After Descemet Stripping And Automated Endothelial Keratoplasty (DSAEK). Cornea 2007;26:670–4.

• Lee WB et al. Descemet’s Stripping Endothelial Keratoplasty: Safety and Outcomes. Ophthalmology 2009;116:1818-1830.

• Melles GR et al. Preliminary Clinical Results of Descemet Stripping Endothelial Keratoplasty. Am J Ophthalmology 2008;145:222-227

• Price FW, Price MO. Descemet’s Stripping with Endothelial Keratoplasty in 200 Eyes: Early Challenges and Techniques to Enhance Donor Adherence. J Cataract Refract Surg 2006;32:411-418.

• Shah AK et al. Complications and Clinical Outcomes of Descemet Stripping Automated Endothelial Keratoplasty With Intraocular Lens Exchange. Am J Ophthalmology 2010;149:390-397.

• Terry MA et al. Endothelial Keratoplasty for Fuchs’ Dystrophy with Cataract. Ophthalmology 2009;116:631-639.

Acknowledgements

Special thanks to:• Thomas E. Gillette, MD• Tueng T. Shen, MD PhD• Shintaro Kanayama, MD PhD• Staff at Eye Associates Northwest

Author:Bryan Y. Kim is a medical student at the University of Washington School of Medicine and is pursuing ophthalmology as a career.