Selective retina therapy (SRT) for clinically significant diabetic macular edema.
OBJECTIVE
To test selective retina therapy (SRT) as a treatment of clinically significant diabetic macular edema (DME).


METHODS
Prospective two-center interventional uncontrolled phase II pilot study. Thirty-nine eyes of 39 patients with previously untreated non-ischemic DME were treated with focal laser treatment using a Q-switched frequency doubled Nd:YLF laser which selectively affects the retinal pigment epithelium while sparing the photoreceptor layer. Optoacoustic measurements, fundus fluorescein angiography (FFA), and funduscopy were used to determine the individual threshold of RPE damage of each patient. The pulse energy was adjusted to apply angiographically visible but funduscopically invisible effects. Optoacoustic measurements were correlated with funduscopy and FFA. Follow-up examinations at 3 and 6 months post-treatment included best-corrected ETDRS visual acuity (BCVA), FFA, fundus photography, and retinal thickness measured by optical coherence tomography. The primary outcome measure was change of BCVA. Other outcome measures were change of retinal thickness, presence of hard exudates, leakage in FFA, accuracy of optoacoustic measurements, and correlation of BCVA with change of anatomical and systemic parameters.


RESULTS
Mean BCVA improved from 43.7 letters (standard deviation, SD=9.1) at baseline to 46.1 letters (SD=10.5) at the 6-month follow-up (p=0.02). BCVA improved (>5 letters) or remained stable (+/-5 letters) in 84% of eyes. Thirteen percent of eyes improved by > or =10 letters, while 16% of eyes lost more than 5 letters. There was no severe loss of vision (> or =15 letters). Overall, retinal thickness, hard exudates, and leakage in FFA did not change significantly (p> 0.05), while improvement of BCVA correlated with a reduction of hard exudates (p=0.01) and central retinal thickness (p=0.01). Specificity and sensitivity of detecting the angiographic visible threshold of RPE damage by optoacoustic measurements were 86% and 70% respectively. No adverse effects or pain were noted during or after treatment. Conclusions Functional and anatomical improvement or stabilization was observed in most patients. SRT appears to be safe. Optoacoustic measurements accurately detect the individual threshold of RPE damage. A randomized trial is required to further test efficacy and safety of SRT as a treatment of clinically significant diabetic macular edema (DME).
Roider
Johann
J
Department of Ophthalmology, University Medical Center Schleswig-Holstein, Campus Kiel, Arnold-Heller Strasse 3, Kiel, Germany. office@auge.uni-kiel.de
Liew
Shiao Hui Melissa
SH
Klatt
Carsten
C
Elsner
Hanno
H
Poerksen
Erk
E
Hillenkamp
Jost
J
Brinkmann
Ralf
R
Birngruber
Reginald
R
D001786:Blood Glucose / Q000032:analysis; D004396:Coloring Agents; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007208:Indocyanine Green; D017075:Laser Coagulation; D053844:Lasers, Solid-State / Q000627:therapeutic use*; D008269:Macular Edema / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology
D001786:Blood Glucose; D004396:Coloring Agents; D006442:Glycated Hemoglobin; D007208:Indocyanine Green
N Engl J Med. 1993 Sep 30;329(14):977-86
8366922
Surv Ophthalmol. 1984 May;28 Suppl:452-61
6379946
Am J Ophthalmol. 1996 Aug;122(2):258-60
8694095
Br J Ophthalmol. 2005 Jan;89(1):74-80
15615751
J Biomed Opt. 2005 Nov-Dec;10(6):064022
16409087
Acta Ophthalmol Scand. 2001 Oct;79(5):435-40
11594975
Ophthalmologe. 1993 Jun;90(3):274-8
8334331
Dev Ophthalmol. 1981;2:308-17
7262416
Eye (Lond). 1999 Apr;13 ( Pt 2):145-50
10450372
Health Phys. 1983 May;44(5):519-31
6853172
Ophthalmology. 1986 Jul;93(7):938-50
3763140
Semin Ophthalmol. 1999 Dec;14(4):210-3
10758221
Arch Ophthalmol. 1985 Dec;103(12):1796-806
2866759
Proc Natl Acad Sci U S A. 1993 Sep 15;90(18):8643-7
8378341
Bull Soc Belge Ophtalmol. 2006;(302):51-69
17265790
Ophthalmology. 2008 Aug;115(8):1366-71, 1371.e1
18675696
Eur J Ophthalmol. 2002 Mar-Apr;12(2):102-8
12022281
Lasers Surg Med. 1995;16(4):380-3
7651059
Lancet. 1998 Sep 12;352(9131):837-53
9742976
Ophthalmology. 2008 Sep;115(9):1447-9, 1449.e1-10
18662829
Ophthalmic Surg Lasers Imaging. 2007 Nov-Dec;38(6):478-83
18050810
Invest Ophthalmol Vis Sci. 2005 Feb;46(2):714-9
15671304
Ophthalmology. 1983 Nov;90(11):1301-17
6664669
Lasers Surg Med. 2000;27(5):451-64
11126439
Trans Ophthalmol Soc U K. 1979 Jul;99(2):314-20
298436
Arch Ophthalmol. 1992 Dec;110(12):1786-92
1463423
Ophthalmology. 1997 Dec;104(12):2030-8
9400762
Br J Ophthalmol. 2004 Sep;88(9):1173-9
15317711
Ophthalmology. 1984 Dec;91(12):1464-74
6521986
Ophthalmology. 1984 Jan;91(1):1-9
6709312
Am J Ophthalmol. 1992 Jun 15;113(6):652-6
1376019
Arch Ophthalmol. 1987 Mar;105(3):424-7
3827722
Arch Ophthalmol. 2001 Aug;119(8):1135-42
11483079
Retina. 2000;20(2):126-33
10783944
Arch Ophthalmol. 1989 Jan;107(1):119-22
2910270
Surv Ophthalmol. 2002 Dec;47 Suppl 2:S253-62
12507627
Surv Ophthalmol. 2002 Dec;47 Suppl 2:S270-7
12507629
Am J Ophthalmol. 1994 May 15;117(5):583-8
8172263
Graefes Arch Clin Exp Ophthalmol. 1998 Mar;236(3):213-9
9541826
Bull World Health Organ. 2004 Nov;82(11):844-51
15640920
Eye (Lond). 1998;12 ( Pt 1):64-8
9614520
Lasers Surg Med. 1997;20(4):409-15
9142680
Arch Ophthalmol. 1996 Sep;114(9):1079-84
8790092
Diabetes Care. 1998 Jan;21(1):143-56
9538986
Semin Ophthalmol. 2001 Mar;16(1):19-24
15487694
Am J Ophthalmol. 2001 Sep;132(3):427-9
11530069
Arch Ophthalmol. 1999 Aug;117(8):1028-34
10448745
Ophthalmology. 1990 Apr;97(4):503-10; discussion 510-1
1691477