Navigated macular laser decreases retreatment rate for diabetic macular edema: a comparison with conventional macular laser

Aljoscha S Neubauer, Julian Langer, Raffael Liegl, Christos Haritoglou, Armin Wolf, Igor Kozak, Florian Seidensticker, Michael Ulbig, William R Freeman, Anselm Kampik, Marcus Kernt, Aljoscha S Neubauer, Julian Langer, Raffael Liegl, Christos Haritoglou, Armin Wolf, Igor Kozak, Florian Seidensticker, Michael Ulbig, William R Freeman, Anselm Kampik, Marcus Kernt

Abstract

Background: The purpose of this study was to evaluate and compare clinical outcomes and retreatment rates using navigated macular laser versus conventional laser for the treatment of diabetic macular edema (DME).

Methods: In this prospective, interventional pilot study, 46 eyes from 46 consecutive patients with DME were allocated to receive macular laser photocoagulation using navigated laser. Best corrected visual acuity and retreatment rate were evaluated for up to 12 months after treatment. The control group was drawn based on chart review of 119 patients treated by conventional laser at the same institutions during the same time period. Propensity score matching was performed with Stata, based on the nearest-neighbor method.

Results: Propensity score matching for age, gender, baseline visual acuity, and number of laser spots yielded 28 matched patients for the control group. Visual acuity after navigated macular laser improved from a mean 0.48 ± 0.37 logMAR by a mean +2.9 letters after 3 months, while the control group showed a mean -4.0 letters (P = 0.03). After 6 months, navigated laser maintained a mean visual gain of +3.3 letters, and the conventional laser group showed a slower mean increase to +1.9 letters versus baseline. Using Kaplan-Meier analysis, the laser retreatment rate showed separation of the survival curves after 2 months, with fewer retreatments in the navigated group than in the conventional laser group during the first 8 months (18% versus 31%, respectively, P = 0.02).

Conclusion: The short-term results of this pilot study suggest that navigated macular photocoagulation is an effective technique and could be considered as a valid alternative to conventional slit-lamp laser for DME when focal laser photocoagulation is indicated. The observed lower retreatment rates with navigated retinal laser therapy in the first 8 months suggest a more durable treatment effect.

Keywords: Navilas®; diabetes mellitus; diabetic macular edema; diabetic retinopathy; macular laser; navigated focal laser.

Figures

Figure 1
Figure 1
Examples before and after laser. Two sample patients conventionally treated (patient A) or treated by Navilas® (patient B). (A) Fluorescein angiography with treatment area marked. (B) Navilas fundus photograph with fluorescein angiography overlay and preplanned laser spots. (C) Three-month follow-up on fluorescein angiography. (D) Fluorescein angiogram with executed laser treatment spots marked by Navilas.
Figure 2
Figure 2
Visual acuity change over time (mean letters gained). Note: *Indicates statistical significance.
Figure 3
Figure 3
Visual acuity change over time [letters gained] matched for age, gender, and baseline visual acuity but unmatched for the number of laser spots. Note: *Indicates significant difference.
Figure 4
Figure 4
Kaplan-Meier analysis of retreatment rate. Notes: After approximately 2 months, the survival curves separate, indicating more retreatments for the conventional laser group (P = 0.02). The 3-month period after first laser treatment, in which usually no retreatment is performed, is marked green.

References

    1. Klein R, Klein BE, Moss SE. The Wisconsin Epidemiological Study of Diabetic Retinopathy: a review. Diabetes Metab Rev. 1989;5:559–570.
    1. Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995;102:716.
    1. Klein R, Klein BE, Moss SE, Davis MD, DeMets DL. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. IV. Diabetic macular edema. Ophthalmology. 1984;91:1464–1474.
    1. Klein R, Knudtson MD, Lee KE, Gangnon R, Klein BE. The Wisconsin Epidemiologic Study of Diabetic Retinopathy XXIII: the twenty-five-year incidence of macular edema in persons with type 1 diabetes. Ophthalmology. 2009;116:497–503.
    1. Klein R, Moss SE, Klein BE, Davis MD, DeMets DL. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XI. The incidence of macular edema. Ophthalmology. 1989;96:1501–1510.
    1. Chen E, Looman M, Laouri M, et al. Burden of illness of diabetic macular edema: literature review. Curr Med Res Opin. 2010;26:1587–1597.
    1. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053.
    1. Elman MJ, Bressler NM, Qin H, et al. Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2011;118:609–614.
    1. Mitchell P, Bandello F, Schmidt-Erfurth U, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology. 2011;118:615–625.
    1. Nguyen QD, Shah SM, Khwaja AA, et al. Two-year outcomes of the ranibizumab for edema of the macular in diabetes (READ-2) study. Ophthalmology. 2010;117:2146–2151.
    1. Stewart MW. Anti-vascular endothelial growth factor drug treatment of diabetic macular edema: the evolution continues. Curr Diabetes Rev. 2012;8:237–246.
    1. Beck RW, Edwards AR, Aiello LP, et al. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009;127:245–251.
    1. Bandello F, Cunha-Vaz J, Chong NV, et al. New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel. Eye (Lond) 2012;26:485–493.
    1. Treatment techniques and clinical guidelines for photocoagulation of diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report Number 2. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1987;94:761–774.
    1. Sharma S, Brown GC, Brown MM, Hollands H, Shah GK. The cost-effectiveness of grid laser photocoagulation for the treatment of diabetic macular edema: results of a patient-based cost-utility analysis. Curr Opin Ophthalmol. 2000;11:175–179.
    1. Smiddy WE. Economic considerations of macular edema therapies. Ophthalmology. 2011;118:1827–1833.
    1. Campbell CJ, Noyori KS, Rittler MC, Innis RE, Koester CJ. The application of fiber laser techniques to retinal surgery. Arch Ophthalmol. 1964;72:850–857.
    1. Meyer-Schwickerath G. Light coagulation; a method for treatment and prevention of the retinal detachment. Albrecht Von Graefes Arch Ophthalmol. 1954;156:2–34. German.
    1. Neubauer AS, Ulbig MW. Laser treatment in diabetic retinopathy. Ophthalmologica. 2007;221:95–102.
    1. Velez-Montoya R, Guerrero-Naranjo JL, Gonzalez-Mijares CC, et al. Pattern scan laser photocoagulation: safety and complications, experience after 1301 consecutive cases. Br J Ophthalmol. 2010;94:720–724.
    1. Nakamura Y, Mitamura Y, Ogata K, Arai M, Takatsuna Y, Yamamoto S. Functional and morphological changes of macula after subthreshold micropulse diode laser photocoagulation for diabetic macular oedema. Eye (Lond) 2010;24:784–748.
    1. Bolz M, Kriechbaum K, Simader C, et al. In vivo retinal morphology after grid laser treatment in diabetic macular edema. Ophthalmology. 2010;117:538–544.
    1. Kernt M, Cheuteu R, Vounotrypidis E, et al. Focal and panretinal photocoagulation with a navigated laser (Navilas) Acta Ophthalmol. 2011;89:e662–e664.
    1. Kozak I, Kim JS, Oster SF, Chhablani J, Freeman WR. Focal navigated laser photocoagulation in retinovascular disease: clinical results in initial case series. Retina. 2012;32:930–935.
    1. Kozak I, Oster SF, Cortes MA, et al. Clinical evaluation and treatment accuracy in diabetic macular edema using navigated laser photocoagulator Navilas. Ophthalmology. 2011;118:1119–1124.
    1. Johnson ML, Bush RL, Collins TC, et al. Propensity score analysis in observational studies: outcomes after abdominal aortic aneurysm repair. Am J Surg. 2006;192:336–343.
    1. McCaffrey DF, Ridgeway G, Morral AR. Propensity score estimation with boosted regression for evaluating causal effects in observational studies. Psychol Methods. 2004;9:403–425.
    1. Silber JH, Rosenbaum PR, Trudeau ME, et al. Multivariate matching and bias reduction in the surgical outcomes study. Med Care. 2001;39:1048–1064.
    1. Landrum MB, Guadagnoli E, Zummo R, Chin D, McNeil BJ. Care following acute myocardial infarction in the Veterans Administration Medical Centers: a comparison with Medicare. Health Serv Res. 2004;39:1773–1792.
    1. Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study Report no 1. Early Treatment Diabetic Retinopathy Study Research Group. Arch Ophthalmol. 1985;103(12):1796–1806.
    1. Photocoagulation for diabetic macular edema: Early Treatment Diabetic Retinopathy Study Report no. 4. The Early Treatment Diabetic Retinopathy Study Research Group. Int Ophthalmol Clin. 1987;27:265–272.
    1. Elman MJ, Aiello LP, Beck RW, et al. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010;117:1064–1077.
    1. Fong DS, Strauber SF, Aiello LP, et al. Comparison of the modified Early Treatment Diabetic Retinopathy Study and mild macular grid laser photocoagulation strategies for diabetic macular edema. Arch Ophthalmol. 2007;125:469–480.

Source: PubMed

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

3
Subskrybuj