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We found no significant correlation between refraction and VA while using LEW in linear regression (r=0.17). Still, younger participants performed better in terms of VA with the device compared to older participants despite no differences in BCVA (p<0.01). The achievable VA with LEW was in general reduced compared to uncorrected VA (0.50 vs 0.40 logMAR). Only myopic subjects reached a significantly higher VA using LEW (p<0.001). Presbyopic subjects showed enhanced near VA (0.25 logMAR) by reading at 15cm with LEW without any further necessary refractive correction. Nearly all patients (80%) showed stereopsis without need for additional adjustments.
We conducted this trial to investigate a new wearable laser-eyewear (LEW). Images of an integrated camera are projected to the retina by a RGB-Laser (<1µW) and MEMS-mirror system. This enables a full-color live video as augmented reality embedded in the field of vision of the wearer. Thin parallel laser beams are projected following the principle of Maxwellian view through the center of the ocular lens to ensure independency of refractive errors. We performed a study with healthy subjects to test this independency.
Visual impairment (VI) is considered as a difficult condition worldwide both for the affected person and for the adequate care regarding therapy and adjustment of the best low vision aid (LVA) for the affected person. Age-related macular degeneration (AMD), diabetic retinopathy and glaucoma are in the majority of cases the reason for VI and blindness in developed countries.1 Other diseases affecting the anterior segment of the eye can also leading to blindness. These includes VI due to corneal diseases, e.g., keratokonus, corneal dystrophies, opacities caused by chemical or thermal burns and graft-versus-host disease (GvHD). While the most patients receive effectively treatment with surgery, like keratoplasty or limbal-stem-cell transplantation, some patients cannot undergo surgery due to ocular risk factors (e.g., uveitis, uncontrolled IOP, vascularization, etc.)2,3 or due to other comorbidities or even rejection of surgery. Often, there are long waiting periods of months or years for patients who could benefit from surgery because a suitable graft is necessary for them.4 These patient cohorts have to sustain from VI and from its implications regarding social miscommunication, reading disability, problems in recognizing faces and in accomplishing activities of daily living. Higher prevalence of depression, decrease of self-sufficiency and a loss of quality of life are the consequences of the above mentioned problems of patients suffering from VI.5–7 Therefore, it is important to support the patient´s visual rehabilitation and subsequently to increase their autonomy. Reading ability can be successfully improved by LVAs, e.g., electronic video (CCTV) or optical magnifiers.8 For most of visually impaired patients, magnification is currently the only option to improve their vision. However, patients with impairment of the optic media and preserved sensory function could enhance their vision by bypassing the diseased anterior part of the eye.3
A new type of retinal imaging LEW might be able to deliver such a bypass: The new technique allows projecting images directly onto the retina and improving thereby the VA of patients. Firstly, this was tried using a technique similar to the “Scanning Laser Ophthalmoscope” (SLO), which was used to project Landolt C´s onto the retina in 1981.9 Later Furness et al investigated the possibility of a direct retinal projection by means of a low-energy laser for LVAs.10 By using a laser, sharp images could be projected onto the retina, independent of the patient´s refractive errors and focusing ability.11 This could be achieved by the principle of “Maxwellian view,” in which the thin parallel laser beam projects images through the center of the ocular lens directly onto the retina.12 This laser projection technique allowed also passing through corneal opacities. The image was projected in a raster pattern, pixel by pixel onto the retina by means of a red laser diode and a mechanical resonance scanner (MRS).13 As a result of advances in recent years, technology has been further developed to project full color images of a camera, integrated into a spectacle, directly onto the retina.12,14,15 For this Retinal Imaging Laser Eye Wear (RILEW), a RGB (Red, Green and Blue)-Laser was used instead of the red laser diode by Furness et al, and the MRS-mirror was replaced by a microelectromechanical (MEMS) system, which allows even higher scan speeds (about 20ns) and thus higher-resolution (see ). Due to an autofocus and automated contrast settings the device can be operated in various circumstances and lighting conditions. The projection eyewear offers the unique opportunity to improve the VA by direct retinal projection in patients with corneal diseases. The wearer sees a full-color video, in real time, monocular as an augmented reality (AR) embed in his central field of vision, which still allows for peripheral vision opposed to virtual reality (VR) systems. Full color is realized by using a Red (640µm wavelength), Green (515µm) and Blue (465µm) laser diode.12
To be used as a LVA a laser eyewear system must satisfy two conditions: First, it is of extreme importance that the device inflicts no harm to the eye. Secondly, it should still be able to project clear images to be useful as a LVA.
The laser used in our study device is classified as a Class-1-laser according the IEC60825-1. The low energy output could be shown to be lower compared to a fluorescent lamp and is therefore harmless to the eye.12,16 To evaluate the second condition, if the device is, despite the low energy output, still able to project clear images independent of refractive errors we performed this prospective, single-site, clinical trial in healthy subjects. Secondary objectives were to investigate if the wearer experiences double vision while using the LEW, if reading is possible and if magnification by approximation is feasible.
Laser treatment is a valuable approach for many retinal conditions, including diabetic macular edema, retinal tears and detachments, proliferative retinopathy, and choroidal neovascularization. Correct coding for retinal laser treatments starts with answering these three key questions.
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A single laser treatment can be used in many different procedures and is represented by a variety of CPT codes. The appropriate CPT code to use is based on the patient’s diagnosis, not the treatment itself (Table 1).1 For example, if laser treatment is indicated for a retinal detachment, the correct CPT code is 67105. If the same laser procedure is indicated for a retinal tear and prophylaxis of retinal detachment, CPT code 67145 is correct.
The next question to answer is whether the laser treatment is considered a major or minor procedure. This is determined by the global period. A major surgery is defined as a procedure with a 90-day global period; a minor surgery has either no global period or a 10-day global period.
Retinal laser therapy can be considered either a major or minor surgery. A crucial step to confirm the correct coding is to note if an examination was performed on the same day. For examinations performed on the same day as a major surgery, append modifier -57, decision for major surgery.
When the laser treatment is a minor surgery, review the documentation for the examination and confirm it meets the definition for modifier -25, or significant, separately identifiable examination the same day as a minor surgery. Consider that, while medically necessary, if the examination was performed to confirm the need for the laser therapy, it is not separately billable. Table 2 is a quick reference guide that provides the Medicare global period for each retinal laser therapy approach and the appropriate modifier to consider for the same-day examination.
Although Medicare Part B has designated global periods for retinal laser therapy codes, other payers may not recognize the same postoperative days. For example, since January 2016, Medicare has assigned a 10-day global period to CPT code 67228 (treatment of extensive or progressive retinopathy [eg, diabetic retinopathy], photocoagulation), while some Medicaid plans still recognize CPT code 67228 as a major surgery with a 90-day postoperative period.
Another good example is CPT code 67145—the global period changed in January 2022 to 10 days, but many commercial and other payers have a delayed implementation.
Determining the global period based on the laser code and payer is essential to correct coding. This will help you properly track the postoperative days and know when to bill for office visits. Additionally, for the same-day examination, the correct modifier, -25 or -57, is dependent on the payers’ global period assignment and the designation of a major or minor surgery.
Developing an internal quick reference guide that outlines the unique payer nuances related to retinal laser therapy codes will assist in appropriate coding of these procedures. For more resources related to retina coding, visit aao.org/retinapm.
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