Medical Policies - Other
Photocoagulation of Macular Drusen
Photocoagulation of macular drusen with laser therapy is considered not medically necessary.
Photocoagulation describes the use of focused laser energy to treat disease. Laser photocoagulation of macular drusen has been evaluated as a method of slowing progression to advanced age-related macular degeneration (AMD).
AMD is a painless, insidious process. In its earliest stages, it is characterized by minimal visual impairment and the presence of large or “soft” drusen, i.e., subretinal accumulations of cellular debris adjacent to the basement membrane of the retinal pigment epithelium.
Large drusen appear as large, pale yellow or pale gray domed elevations and result in thickening of the space between the retinal pigment epithelium and its blood supply, the choriocapillaris. Clinical and epidemiologic studies have shown that the presence of large and/or numerous soft drusen is associated with an increased risk of the development of choroidal neovascularization (CNV) in eyes with AMD. For example, in patients with bilateral drusen, the 3-year risk of developing CNV is estimated to be 13%, rising to 18% for those older than age of 65 years. The emergence of CNV greatly increases the risk of subsequent irreversible loss of vision.
Two different kinds of low energy laser therapies, argon and infrared laser, have been investigated as techniques to eliminate drusen by photocoagulation in an effort to prevent the evolution to CNV, ultimately leading to improved preservation of vision. The lasers used are those that are widely used for standard photocoagulation of extrafoveal CNV. Therefore, the treatment of macular drusen represents an additional indication for an existing laser approved by the U.S. Food and Drug Administration (FDA).
Laser photocoagulation for macular drusen is a procedure and, as such, is not subject to regulation by the FDA. However, laser devices used to perform photocoagulation are regulated by the FDA. They are classified under two product codes, HQB (Ophthalmic Photocoagulator) and HQF (Ophthalmic Laser), incorporating more than 100 approved devices. An example of an ophthalmic laser used for photocoagulation of macular drusen is the Iris Medical OcuLight
(Iridex Corp.) (product code HQF). This device was approved by the FDA on August 27, 2003. (1)
This policy was originally created in December 2003 and has been updated regularly with searches of the MEDLINE database. Most recently, the literature was searched through April 30, 2018. Following is a summary of the key literature to date.
While studies have shown that laser therapy can induce regression of drusen, not only at the treatment site, but also at sites remote from the laser, (2-4) outcomes of greatest interest are preventing vision loss from atrophy and choroidal neovascularization (CNV). Unfortunately, the biologic rationale has not translated into patient benefit, as demonstrated in multiple trials.
Following initially optimistic results, (2) Figueroa and colleagues updated follow-up in 46 patients with confluent soft drusen. (5) A total of 30 patients with bilateral drusen were randomized to receive argon green laser therapy in 1 eye. The remaining 16 patients had CNV in 1 eye and laser therapy performed on the other eye. Although laser therapy resulted in resolution of the drusen, after 3 years there was no difference between the groups regarding development of CNV.
The Choroidal Neovascular Prevention Trial (CNVPT) randomized eyes with exudative age-related macular degeneration (AMD) in 1 eye and 10 or more large drusen in the other (Fellow Eye Study, 120 patients, 120 study eyes) or bilateral large drusen without exudative AMD (Bilateral Drusen Study, 156 patients, 312 study eyes) to receive argon green laser therapy or observation. (6) Due to an increased incidence of CNV in laser-treated eyes, enrollment and treatment was suspended in December 1996. An earlier report excluding eyes developing CNV found eyes with 50% or more drusen reduction at 1 year had more increases in visual acuity compared to the control group. (7) An updated report from the Fellow Eye Study found no significant differences in visual acuity between photocoagulation or observation eyes during a 4-year follow-up. (8) In addition, the authors noted an increased risk of CNV in treated eyes treated early during follow-up (23% treated eyes vs. 5% observed at 1 year) but this diminished over time (33% and 32% at 30 months, respectively). Higher intensity laser treatment was associated with greater risk of developing CNV.
The National Eye Institute-sponsored Complications of AMD Prevention Trial (CAPT) enrolled patients with bilateral large drusen (n=1,052); 1 eye was assigned to low-intensity laser treatment and the other to observation. After 5 years, there were no differences between treated and observed eyes in worsening visual acuity (20.5% in both groups lost >3 ETDRS [Early Treatment of Diabetic Retinopathy Study] lines), development of CNV (13.3% in both groups), or geographic atrophy. (9)
A pilot study of infrared laser therapy (810 nm) enrolled 152 patients (229 eyes) who had either bilateral drusen or unilateral drusen if CNV was detected in the fellow eye. (10) Eyes were randomized to receive laser therapy or observation. While laser therapy was associated with resolution of drusen and improved visual acuity, the study was not powered to detect an effect on progression to CNV. Based on these results, the prophylactic treatment of AMD trial (PTAMD) followed 244 patients with CNV or advanced AMD in 1 eye and equal to or greater than 5 drusen and no CNV in the fellow eye. (11) Treatment consisted of an extrafoveal grid of subthreshold 810-nm laser spots. Enrollment was halted after 47 months due to an excess of CNV in treated eyes. CNV occurred more often in treated eyes (15.8% vs. 1.4% at 1 year); there were no differences in moderate (>3 ETDRS lines) visual loss after 6 months, with or without treatment.
The drusen laser study randomized patients with eyes at high risk for AMD. (12) Follow-up was completed over 3 years. A unilateral group (n=177) in the trial included patients with drusen in the study eye and CNV in the fellow eye; the bilateral group (n=105) had drusen in both eyes. The treatment protocol was revised, and recruitment ultimately halted after 23 months due to concerns over laser-induced CNV in interim analyses. In the unilateral group, prophylactic laser treatment hastened the onset of CNV (29.7% vs. 17.7% observed, respectively; p=0.06) and was associated with worsening visual acuity. In the bilateral group, 3-year CNV incidence was 11.6% in laser-treated eyes versus 6.8% without treatment (p=0.22). In both groups, visual loss paralleled development of CNV.
In 2009, Friberg and colleagues from the PTAMD study group reported 3-year outcomes from 639 participants (1,278 eyes). (13) Treatment consisted of the placement of an annular grid of 48 extrafoveal, subthreshold laser applications in one eye of each participant. Subthreshold laser treatment did not decrease the incidence of CNV in comparison with the other (fellow) eye. A very slight benefit in visual acuity (1.5 letter difference) was found at 24 months, but this effect was not sustained at 3 years. The authors concluded that a single subthreshold 810-nanometer laser treatment to eyes of participants with drusen is not an effective prophylactic strategy against CNV.
A Cochrane review on laser treatment of drusen to prevent progression to advanced AMD was published in 2009. (14) Nine randomized studies with a total of 2,216 patients were included in the systematic review. Two of the studies reported significant drusen disappearance at 2 years, but photocoagulation did not appear to affect the development of CNV at 2 years’ follow-up. The authors concluded that the trials confirmed the clinical observation that laser photocoagulation of drusen leads to their disappearance. However, there is no evidence that this reduces the risk of developing CNV, geographic atrophy, or visual acuity loss.
Lenassi and colleagues (2013) performed a prospective, interventional case series that evaluated the laser clearance of drusen deposits in patients with autosomal dominant drusen. (15) The goal was to assess whether laser treatment to the retinal pigment epithelium anterior to drusen in eyes of patients with EFEMP1-related maculopathy affects visual acuity, deposit volume, and retinal sensitivity. In 11 patients with autosomal dominant drusen and confirmed disease-causing EFEMP1 mutation, the worse-seeing eye was treated with Argon green laser (10 to 15 laser spots; 200-μm spot size, 0.1-second duration, 80 to 120 mW). Patients were examined before treatment as well as 1, 3, 6, and 12 months after the procedure. Clinical assessment included visual acuity, fundus-controlled perimetry, spectral-domain optical coherence tomography, and autofluorescence imaging. Custom-made software allowed for coregistration of fundus-controlled perimetry and spectral-domain optical coherence tomography data sets. The main outcome measures were change in visual acuity, retinal sensitivity, and drusen volume. The untreated eyes lost an average of 0.8 letters, whereas the treated eyes gained an average of 4.9 letters. For fundus-controlled perimetry, locus-by-locus differences in sensitivity were calculated between pretreatment and posttreatment assessments; subsequently, the overall difference in the treated and untreated eye was compared. Five patients showed significant improvement in retinal sensitivity, 5 patients showed no change, and 1 patient showed significant deterioration. An increase in mean drusen thickness was observed in the untreated eyes, but not in the treated eyes (P = .0322). The thickness of the drusen correlated with retinal sensitivity (ρ = -0.49; P < .0001). Safety was demonstrated and no adverse events were observed. The authors concluded that low-energy laser treatment is safe and may be effective in the treatment of autosomal dominant drusen and further evaluation with long-term assessment is required to confirm the benefits.
In 2015, Virgili et al. published a Cochrane systematic review of the literature on laser treatment of macular drusen. (16) Eleven randomized controlled trials (RCTs) with a total of 2159 patients comparing laser treatment to no treatment or a sham intervention were included. In a meta-analysis of the 11 trials, compared with control interventions, photocoagulation did not significantly reduce the risk of developing CNV 2 years after treatment (odds ratio [OR], 1.07, 95% confidence interval [CI]; 0.79 to 1.46). Meta-analyses of secondary outcomes found that photocoagulation did not significantly decrease visual loss of 2 or more lines (9 studies, OR, 0.99, 95% CI; 0.81 to 1.22) or increase the likelihood of drusen reduction (3 studies, OR, 9.16, 95% CI; 6.28 to 13.37). A meta-analysis of 2 trials found a statistically significant reduction in the development of geographic atrophy with laser treatment versus control, but the CI in this analysis was wide (OR, 1.30, 95% CI; 0.38 to 4.51). The authors concluded that photocoagulation does not result in a reduction in the risk of developing CNV, and was not shown to limit the occurrence of geographic atrophy or visual acuity loss. The authors indicated that ongoing studies are being conducted to assess whether the use of extremely short laser pulses (i.e., nanosecond laser treatment) can not only lead to drusen regression but also prevent neovascular AMD.
Practice Guidelines and Position Statements
In 2015, the American Academy of Ophthalmology (AAO) updated their preferred practice pattern for AMD which recommends regular dilated eye exams for the early detection of the intermediate stage of AMD and possible treatment with antioxidants and minerals for patients who have progressed to intermediate or advanced AMD in 1 eye. No recommendations were made regarding photocoagulation of macular drusen. The guidelines state that “patients with intermediate AMD who are at increased risk of visual loss or of progression to advanced AMD should be educated about methods of detecting new symptoms of CNV and about the need for prompt notification to an ophthalmologist who can confirm if the new symptoms are from CNV and who can begin treatment if indicated.” (17)
Summary of Evidence
Evidence from multiple trials indicates that drusen ablation does not prevent visual loss, CNV, or AMD. Furthermore, the evidence from trials indicates that drusen ablation may be accompanied by harm. The literature indicates that photocoagulation of macular drusen procedure is not clinically appropriate; this approach is considered not medically necessary.
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1. FDA – 510(k) Summary (2003). OcuLight® (k031665). Available at <http://www.accessdata.fda.gov> (accessed May 15, 2018).
2. Figueroa MS, Regueras A, Bertrand J, et al. Laser photocoagulation to treat macular soft drusen in age-related macular degeneration. Retina. 1994; 14(5):391-6. PMID 7899712
3. Frennesson IC. and Nilsson SE. Effects of argon (green) laser treatment of soft drusen in early age-related maculopathy: a 6-month prospective study. Br J Ophthalmol. 1995; 79(10):905-9. PMID 7488578
4. Frennesson C. and Nilsson SE. Prophylactic laser treatment in early age related maculopathy reduced the incidence of exudative complications. Br J Ophthalmol. 1998; 82(10):1169-74. PMID 9924306
5. Figueroa MS, Regueras A, Bertrand J, et al. Laser photocoagulation for macular soft drusen. Updated results. Retina. 1997; 17(5):378-84. PMID 9355184
6. Ho AC, Maguire MG, Yoken J, et al. Laser-induced drusen reduction improves visual function at 1 year. Choroidal Neovascularization Prevention Trial Research Group. Ophthalmology. 1999; 106(7):1367-73. PMID 10406624
7. Choroidal Neovascularization Prevention Trial Research Group. Choroid neovascularization in the Choroidal Neovascular Prevention Trial. Ophthalmology. 1998; 105(8):1364-72. PMID 9709744
8. Choroidal Neovascularization Prevention Trial Research Group. Laser treatment in fellow eyes with large drusen: updated findings from a pilot randomized clinical trial. Ophthalmology. 2003; 110(5):971-8. PMID 12750100
9. Complications of Age-Related Macular Degeneration Prevention Trial Research Group. Laser treatment in patients with bilateral large drusen: the complications of age-related macular degeneration prevention trial. Ophthalmology. 2006; 113(11):1974-86. PMID 17074563
10. Olk RJ, Friberg TR, Stickney KL, et al. Therapeutic benefits of infrared (810-nm) diode laser macular grid photocoagulation in prophylactic treatment of nonexudative age-related macular degeneration: two-year results of a randomized pilot study. Ophthalmology. 1999; 106(11):2082-90. PMID 10571341
11. Friberg TR, Musch DC, Lim JI, et al. Prophylactic treatment of age-related macular degeneration report number 1: 810-nanometer laser to eyes with drusen. Unilaterally eligible patients. Ophthalmology. 2006; 113(4):622. PMID 16581422
12. Owens SL, Bunce C, Brannon AJ, et al. Prophylactic laser treatment hastens choroidal neovascularization in unilateral age-related maculopathy: final results of the drusen laser study. Am J Ophthalmol. 2006; 141(2):276-81. PMID 16458680
13. Friberg TR, Brennen PM, Freeman WR, et al. Prophylactic treatment of age-related macular degeneration report number 2: 810-nanometer laser to eyes with drusen: bilaterally eligible patients. Ophthalmic Surg Lasers Imaging. 2009; 40(6):530-8. PMID 19928717
14. Parodi MB, Virgili G, Evans JR. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev. 2009; (3):CD006537. PMID 19588397
15. Lenassi E, Troeger E, Wilke R, et al. Laser clearance of drusen deposit in patients with autosomal dominant drusen. Am J Opthalmol. 2013; 155(1):190-198. PMID 23036572
16. Virgili G, Michelessi M, Parodi MB, et al. Laser treatment of drusen to prevent progression to advanced age-related macular degeneration. Cochrane Database Syst Rev. 2015; 10:CD006537. PMID 26493180
17. American Academy of Ophthalmology. Age-Related Macular Degeneration Preferred Practice Pattern. San Francisco: American Academy of Ophthalmology, (2009, revised 2015). Available at <http://www.aao.org> (accessed May 15, 2018).
18. Photocoagulation of Macular Drusen (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2011 May) Vision 9.03.11
|7/15/2018||Document updated with literature review. Coverage unchanged. Added references 1, 16.|
|7/15/2017||Reviewed. No changes|
|7/15/2016||Document updated with literature review. Coverage unchanged.|
|2/1/2015||Document updated with literature review. Coverage unchanged.|
|12/15/2012||Document updated with literature review. Coverage unchanged.|
|11/1/2010||CPT/HCPCS code(s) updated (with bit changes)|
|9/15/2009||Revised/updated entire document. No coverage changes. This policy is no longer scheduled for routine literature review and update.|
|9/15/2007||Revised/updated entire document|
|6/15/2006||Revised/updated entire document|
|12/1/2003||New medical document|
|Title:||Effective Date:||End Date:|
|Photocoagulation of Macular Drusen||07-15-2017||07-14-2018|
|Photocoagulation of Macular Drusen||07-15-2016||07-14-2017|
|Photocoagulation of Macular Drusen||02-01-2015||07-14-2016|
|Photocoagulation of Macular Drusen||12-15-2012||01-31-2015|
|Photocoagulation of Macular Drusen||11-01-2010||12-14-2012|
|Photocoagulation of Macular Drusen||09-15-2009||10-31-2010|
|Photocoagulation of Macular Drusen||09-15-2007||09-14-2009|
|Photocoagulation of Macular Drusen||06-15-2006||09-14-2007|
|Photocoagulation of Macular Drusen||12-01-2003||06-14-2006|